A Randomized Trial of Caregiver-Mediated Function-Based Elopement Treatment for Autistic Children
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| Title: | A Randomized Trial of Caregiver-Mediated Function-Based Elopement Treatment for Autistic Children |
|---|---|
| Language: | English |
| Authors: | Mindy Scheithauer (ORCID |
| Source: | Autism: The International Journal of Research and Practice. 2025 29(8):1973-1986. |
| Availability: | SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: https://sagepub.com |
| Peer Reviewed: | Y |
| Page Count: | 14 |
| Publication Date: | 2025 |
| Document Type: | Journal Articles Reports - Research |
| Education Level: | Adult Education |
| Descriptors: | Behavior Problems, Children, Preadolescents, Autism Spectrum Disorders, Program Effectiveness, Parent Education, Parent Role, Intervention, Functional Behavioral Assessment, Safety |
| Assessment and Survey Identifiers: | Aberrant Behavior Checklist, Autism Diagnostic Observation Schedule, Childhood Autism Rating Scale |
| DOI: | 10.1177/13623613251330388 |
| ISSN: | 1362-3613 1461-7005 |
| Abstract: | Elopement is a common and dangerous behavior among autistic children. Behavioral treatments can reduce elopement, but most evidence comes from small-N evaluations in specialized settings with strategies varying across studies. The current study compared the efficacy of the caregiver-mediated function-based elopement treatment to parent education program (PEP) in a 16-week randomized clinical trial of 76 autistic children (age = 4-12 years). Function-based elopement treatment involves 12 weekly appointments aimed at improving safety, identifying the function of elopement, and implementing subsequent function-based treatment strategies. No group differences were observed on the Aberrant Behavior Checklist-Hyperactivity (primary outcome). Significant improvement from baseline to endpoint in function-based elopement treatment compared to parent education program participants was observed for secondary outcomes, including caregiver ratings of safety measures (p < 0.01), severity of elopement based on the Elopement Questionnaire (p < 0.01), and caregiver-collected data on elopement (p < 0.01). The Clinical Global Impression--Improvement Scale (CGI-I) rated by a treatment-blind evaluator found 31.6% of function-based elopement treatment participants improved compared to 2.6% in parent education program (p = 0.001). Improvements were maintained at a 28-week follow-up. Attrition was 5.26%, and no significant adverse events were deemed related to treatment. Function-based elopement treatment was superior to parent education program on elopement-specific outcomes and appears safe and acceptable. |
| Abstractor: | As Provided |
| Entry Date: | 2025 |
| Accession Number: | EJ1476855 |
| Database: | ERIC |
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| FullText | Links: – Type: pdflink Url: https://content.ebscohost.com/cds/retrieve?content=AQICAHj0k_4E0hTGH8RJwT4gCJyBsGNe_WN95AvKlDbXJGqwxwGDDnBhH1Kag3UZXWH14dqXAAAA4jCB3wYJKoZIhvcNAQcGoIHRMIHOAgEAMIHIBgkqhkiG9w0BBwEwHgYJYIZIAWUDBAEuMBEEDATkPebNZ-IzTsdnOwIBEICBmoxzk9ntevF7M1SySSoO2Dq3zbSwBfu_tBS_5hZ36m2pbKXQGlZxdiNWFJqK_N5hGzuBHxGaFf2K26H4mDzk6Kk8hmpVA1VD7WatYKKobOaHy91GcgDEeWnouhHui2kpyzqeZ5s0HSCUjXmB0Y6JL1plY70k3Gj902onifngKl48t0gOeja2K2ZakUF6rBLLg20dhd4j4Urt_YU= Text: Availability: 1 Value: <anid>AN0186601740;f9d01aug.25;2025Jul15.05:29;v2.2.500</anid> <title id="AN0186601740-1">A Randomized Trial of Caregiver-Mediated Function-Based Elopement Treatment for Autistic Children </title> <p>Elopement is a common and dangerous behavior among autistic children. Behavioral treatments can reduce elopement, but most evidence comes from small-N evaluations in specialized settings with strategies varying across studies. The current study compared the efficacy of the caregiver-mediated function-based elopement treatment to parent education program (PEP) in a 16-week randomized clinical trial of 76 autistic children (age = 4–12 years). Function-based elopement treatment involves 12 weekly appointments aimed at improving safety, identifying the function of elopement, and implementing subsequent function-based treatment strategies. No group differences were observed on the Aberrant Behavior Checklist-Hyperactivity (primary outcome). Significant improvement from baseline to endpoint in function-based elopement treatment compared to parent education program participants was observed for secondary outcomes, including caregiver ratings of safety measures (p &lt; 0.01), severity of elopement based on the Elopement Questionnaire (p &lt; 0.01), and caregiver-collected data on elopement (p &lt; 0.01). The Clinical Global Impression–Improvement Scale (CGI-I) rated by a treatment-blind evaluator found 31.6% of function-based elopement treatment participants improved compared to 2.6% in parent education program (p = 0.001). Improvements were maintained at a 28-week follow-up. Attrition was 5.26%, and no significant adverse events were deemed related to treatment. Function-based elopement treatment was superior to parent education program on elopement-specific outcomes and appears safe and acceptable. Many autistic children exhibit wandering or running away from supervision (i.e. elopement), which can include leaving the house in the middle of the night or getting lost from a parent in a crowded location. Elopement can result in injury when the child is not supervised and is incredibly stressful for parents. Research suggests that behavioral intervention can help with elopement. However, most studies include only a few children. In addition, treatment strategies differ across studies, making it difficult to compare outcomes. The function-based elopement treatment has compiled strategies across different studies to build a 12-session treatment manual that can be followed by clinicians. The manual guides the therapist on the delivery of parent-training strategies to improve the child's safety and reduce elopement. We compared function-based elopement treatment to a control condition where parents met weekly with a clinician for more general parent training. Children whose parents received function-based elopement treatment showed greater improvement in elopement than children whose parents received more general parent education. This result suggests that the treatment works. Further study is needed to move function-based elopement treatment into clinical practice.</p> <p>Keywords: autism spectrum disorders; elopement; function-based treatment; interventions—psychosocial/behavioral; randomized clinical trial</p> <p>Elopement, defined as wandering or running away from adult supervision, is common and dangerous for autistic children. In 2017, the National Autism Association published a review of 808 cases of missing autistic persons. A third of these cases were fatal, and another third were classified as close calls ([<reflink idref="bib25" id="ref1">25</reflink>]). In a parent survey of 3518 children (age = 6–17 years), elopement was reported in 42% of the sample in the past year ([<reflink idref="bib18" id="ref2">18</reflink>]). A separate survey of 1218 parents of children (age = 4–17 years) reported elopement in 49% of autistic youth compared to only 13% of siblings without autism ([<reflink idref="bib3" id="ref3">3</reflink>]). Just over half of the children with a history of elopement had at least one incident in which the duration was long enough to cause concern. Close calls for injury were common: 65% with a traffic incident and 24% with drowning ([<reflink idref="bib3" id="ref4">3</reflink>]). Elopement is associated with significant caregiver stress ([<reflink idref="bib3" id="ref5">3</reflink>]; [<reflink idref="bib22" id="ref6">22</reflink>]).</p> <p>Available evidence from single-case studies and small sample case series suggests that interventions based in applied behavior analysis (ABA) can reduce elopement in autistic children (e.g. [<reflink idref="bib6" id="ref7">6</reflink>]; [<reflink idref="bib7" id="ref8">7</reflink>]; [<reflink idref="bib17" id="ref9">17</reflink>]; [<reflink idref="bib33" id="ref10">33</reflink>]). These interventions focus on the antecedents to (i.e. events or situations that precede elopement) and consequences of elopement (i.e. events that follow elopement) to identify the function, or purpose, of the behavior ([<reflink idref="bib6" id="ref11">6</reflink>]; [<reflink idref="bib15" id="ref12">15</reflink>]). The function is then used to inform intervention by teaching the individual who elopes an appropriate replacement behavior to obtain the functional reinforcer and ensuring the reinforcer is delivered following the appropriate behavior instead of elopement (i.e. differential reinforcement). For example, a therapist might provide a preferred item following an appropriate request rather than elopement in pursuit of the preferred item (see [<reflink idref="bib37" id="ref13">37</reflink>] for an overview of function-based treatments).</p> <p>The body of evidence for these interventions from single-subject studies ([<reflink idref="bib6" id="ref14">6</reflink>]) and case series analyses ([<reflink idref="bib7" id="ref15">7</reflink>]) is informative but has several limitations. First, treatment components differ across these studies (e.g. how reinforcement is implemented). Second, most studies were conducted in specialized settings by researchers and therapists that specialize in function-based interventions. Third, the small samples limit the generalizability of results. Fourth, few studies included caregiver training to promote maintenance of treatment effects. Caregiver training is especially relevant for implementing strategies to reduce elopement-related safety risks, which have largely been excluded from past studies focused on behavioral interventions for elopement. Last, most studies have not evaluated the maintenance of behavior change with follow-up data.</p> <p>Caregivers endorse having access to minimal information regarding how to manage elopement, with most information limited to online postings and recommendations from pediatricians ([<reflink idref="bib22" id="ref16">22</reflink>]). Most caregivers of autistic children who elope also report having very few safety procedures in place ([<reflink idref="bib28" id="ref17">28</reflink>]). This deficit in accessing care may be attributable to the above-mentioned limitations in research. Variable treatment components across studies might limit implementation by community-based clinicians, especially given that most Board Certified Behavior Analysts (BCBAs<sups>©</sups>; a primary provider of therapeutic care for autistic children; [<reflink idref="bib8" id="ref18">8</reflink>]) do not receive specialized training in the treatment of concerns such as elopement ([<reflink idref="bib27" id="ref19">27</reflink>]). Community-based BCBAs also report barriers in providing caregiver training ([<reflink idref="bib14" id="ref20">14</reflink>]).</p> <p>To address the gaps in past research that may be contributing to barriers in accessing care for elopement, the function-based elopement treatment (FBET) manual was developed. The FBET manual is built on the behavior analytic conceptualization of elopement as a learned behavior that serves a specific function for the individual and, as such, is amenable to differential reinforcement (described above; [<reflink idref="bib40" id="ref21">40</reflink>]). FBET is a structured, 12-week caregiver-mediated intervention that includes therapist scripts designed to coach caregivers on implementing an assessment with the child to identify the function of elopement and then uses the results of this assessment to coach the caregiver through implementing appropriate function-based treatment strategies. FBET includes instructions for implementing prevention and safety strategies related to elopement and is designed to be implemented in community-based settings (e.g. the child's home or public locations where elopement is common) by behavioral therapists that do not have specialization in treating elopement. The companion caregiver workbook includes handouts on each topic.</p> <p>In a pilot randomized trial of 24 autistic children with elopement, FBET was acceptable to parents as evidenced by low attrition and high attendance. Therapists delivered the intervention with greater than 90% fidelity. Compared to the waitlist group, children in FBET showed greater reduction in parent-rated hyperactivity (Aberrant Behavior Checklist-Hyperactivity subscale (ABC-H)) and parents in FBET were more successful in implementing safety measures ([<reflink idref="bib33" id="ref22">33</reflink>]).</p> <p>Although promising, this was a small sample, did not include an active control group, outcomes were not elopement-specific, and follow-up data were limited. The current study extends these findings in a larger randomized controlled trial (RCT) with 76 autistic youth randomized to receive either FBET or an active control condition (Parent Education Program; PEP) with the following hypotheses:</p> <p></p> <ulist> <item> <emph>HQ1. Participants receiving FBET, compared to PEP, will show significant improvement on the ABC-H.</emph> </item> <p></p> <item> <emph>HQ2. Significantly more participants receiving FBET, compared to PEP, will be marked as improved by a blinded evaluator on the CGI-I at endpoint.</emph> </item> <p></p> <item> <emph>HQ3. Participants receiving FBET, compared to PEP, will show significant improvement on elopement-specific measures (including caregiver ratings on elopement safety, caregiver-collected data on elopement, and an exploratory outcome of the severity of elopement based on a caregiver-completed questionnaire) from baseline to endpoint.</emph> </item> <p></p> <item> <emph>HQ4. Improvement noted on outcome measures following FBET will maintain at follow-up.</emph> </item> </ulist> <hd id="AN0186601740-2">Methods</hd> <p></p> <hd id="AN0186601740-3">Design</hd> <p>Between May 2019 and November 2022, participants were randomly assigned to FBET or a PEP for 12 sessions delivered over approximately 16 weeks for flexibility in scheduling. Following the randomized phase, caregivers of children in PEP were offered FBET. The single-site study was conducted in an outpatient autism center that provides diagnostic assessments and specialized services for behavioral problems, feeding disorders, and language delays in autistic children. A separate team at the center provided data management and data analysis. An unblinded statistician monitored recruitment, attrition, adverse events, and data quality and provided reviews every 6 months. The trial ended when recruitment goals were met.</p> <hd id="AN0186601740-4">Research ethics, conflicts of interest, and funding</hd> <p>The Institutional Review Board (IRB) at Emory University approved the trial, and caregivers provided informed consent. The IRB waived assent due to age and developmental delays in the population. For children with the ability to understand the study procedures, an investigator reviewed the fundamentals of the study and answered questions. All study procedures were conducted in accordance with the World Medical Association Declaration of Helsinki.</p> <p>This study was supported by an Autism Speaks Treatment Grant; authors received grant funding from this organization. The authors work in an autism clinic and use behavioral treatments in their clinical responsibilities.</p> <hd id="AN0186601740-5">Participants and recruitment</hd> <p>Caregivers of children with a presenting concern of elopement on the clinic waitlist were informed about the study. Participants were also recruited through clinician referrals and self-referrals (from marketing regarding the study posted through the clinic). After an initial phone call to gauge interest, a study coordinator completed a screen with caregivers for a preliminary review of inclusion/exclusion criteria. Next, a study investigator conducted a consent procedure in person or using videoconference with parents of potentially eligible participants. Written informed consent was obtained before the collection of study data.</p> <p>Eligible children were aged 4–12 years diagnosed with autism, a caregiver-reported primary concern of elopement, and a score of ⩾18 on the ABC-H subscale. Diagnosis was based on history and supported by the Autism Diagnostic Observation Schedule ([<reflink idref="bib21" id="ref23">21</reflink>]) prior to the COVID-19 pandemic and the Childhood Autism Rating Scale 2 ([<reflink idref="bib34" id="ref24">34</reflink>]) or the Autism Diagnostic Interview–Revised ([<reflink idref="bib31" id="ref25">31</reflink>]) during and post COVID-19.</p> <p>Children of caregivers who expressed doubt about meeting study requirements (e.g. regular attendance) or reported primary concerns (medical or behavioral) that required a different treatment were excluded. Children on medication or receiving other treatments were included if the medication/treatment was stable for at least a month with no planned changes for the study duration. Behavioral and medical concerns and ongoing or planned treatments were assessed through a caregiver interview. Concerns that may have indicated exclusion were discussed with the research team (at least two licensed psychologists and doctoral-level behavior analysts) to come to a consensus about inclusion/exclusion. If all entry criteria were met, the study coordinator scheduled a baseline evaluation.</p> <hd id="AN0186601740-6">Characterization</hd> <p>All participants completed a detailed assessment prior to randomization, including autism (described above), cognitive, and adaptive assessments. Differential Abilities Scale ([<reflink idref="bib12" id="ref26">12</reflink>]) or Mullen Scales of Early Learning ([<reflink idref="bib23" id="ref27">23</reflink>]), based on the child's age and developmental level, evaluated cognitive capacity. Adaptive functioning was assessed with the Vineland Adaptive Behavior Scales III ([<reflink idref="bib38" id="ref28">38</reflink>]).</p> <p>All medications were recorded at baseline and updated at each visit. Psychotropic medications are reported for all participants. Medications with multiple potential indications were included if the caregiver reported the indication was for a behavioral or mental health concern (e.g. clonidine was included if indicated for behavioral concerns but excluded if indicated for sleep).</p> <hd id="AN0186601740-7">Randomization and blinding</hd> <p>At the baseline visit, children were randomly assigned to FBET or PEP in a 1:1 ratio using permuted blocks of two and four in a parallel design (PEP participants were offered FBET after the conclusion of the endpoint visit). The allocation pattern was known only by the statistician who managed randomization. The statistician provided the random assignment in a sealed envelope to the study coordinator, who informed the caregiver. Caregivers, the coordinator, and therapists were aware of treatment assignment. It was not feasible to have caregivers or therapists blind to treatment assignment given the nature of a behavioral caregiver-mediated intervention that required caregiver and therapist awareness of treatment goals. It was essential for the primary caregiver to complete outcome questionnaires and home-data given their knowledge of the child. However, the independent evaluator (IE) was an investigator blind to treatment assignment. This treatment-blind IE met with the caregiver at each assessment timepoint and reminded the caregiver they were blind to group assignment and of topics to avoid discussing to protect the blind. The IE completed the parent target problem narrative, Clinical Global Impression (CGI) ratings, and adverse event recording.</p> <p>Upon completion of the baseline visit, the coordinator scheduled FBET or PEP sessions for each participant. Assessment visits were scheduled at midpoint (Week 8), endpoint (Week 16), and follow-up (Week 28). Outcomes were completed at each timepoint (baseline, midpoint, endpoint, and follow-up) unless otherwise specified. For 17.10% of endpoint and follow-up visits, protocol deviations occurred where researchers collected at least one outcome measure after the designated window (±14 days from target assessment date) due to rescheduling the IE visit or late return of questionnaires. The average length from baseline to endpoint was 16.6 weeks (range = 14.3–20.1) and to follow-up was 28.72 weeks (range = 27–32.42).</p> <p>To avoid lengthy delays to participants receiving the active treatment (and improve acceptability of the trial), participants randomized to PEP were offered FBET after the endpoint visit. However, due to the complexity of scheduling, most PEP participants completed very few crossover appointments prior to their follow-up assessment (M = 2.89; Mdn = 2; range = 0–9 crossover FBET appointments completed before follow-up). Thus, we included follow-up data based on randomized group regardless of cross-over status.</p> <hd id="AN0186601740-8">Outcome measures</hd> <p></p> <hd id="AN0186601740-9">Primary outcome</hd> <p></p> <hd id="AN0186601740-10">Aberrant Behavior Checklist</hd> <p>The Aberrant Behavior Checklist (ABC) is a validated, 58-item caregiver-completed measure with five subscales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactivity, Inappropriate Speech; [<reflink idref="bib16" id="ref29">16</reflink>]). Items are scored from 0 to 3, with higher scores indicating greater severity. The ABC has been used in several clinical trials with autistic children (e.g. [<reflink idref="bib4" id="ref30">4</reflink>]; [<reflink idref="bib33" id="ref31">33</reflink>]). We used the 16-item ABC-H subscale as the primary outcome.</p> <p>Although the ABC-H is not specifically intended to measure elopement, it was selected due to a dearth of validated measures specific to elopement, with past research relying on a single or few-item parent report ([<reflink idref="bib3" id="ref32">3</reflink>]). Although not designed as a measure of elopement, the ABC-H contains items on hyperactivity, impulsiveness, and noncompliant behavior that are often relevant to elopement and demonstrated sensitivity to change with FBET in the pilot study. Thus, given the large precedent for the use of the ABC in clinical trials with autistic youth, the ABC-H was selected as the primary outcome. However, other elopement-specific measures were also included (described below) to ensure comprehensive multi-modal measurement of elopement. The ABC-Irritability subscale (ABC-I) was evaluated as an exploratory outcome given its prevalent use in past parent-mediated interventions for behavioral concerns.</p> <hd id="AN0186601740-11">Secondary outcomes</hd> <p></p> <hd id="AN0186601740-12">Caregiver-collected home elopement data</hd> <p>For 1-week preceding IE visits, caregivers recorded whether an episode of elopement occurred that day (secondary outcome), including elopement attempts successfully stopped. For analyses, this was converted to a percentage of days that elopement occurred.</p> <hd id="AN0186601740-13">Elopement safety checklist</hd> <p>This 22-item caregiver-reported checklist (secondary outcome), designed for the pilot study of FBET ([<reflink idref="bib33" id="ref33">33</reflink>]), is based on a review of items recommended in published safety toolkits for elopement (e.g. [<reflink idref="bib24" id="ref34">24</reflink>]). The checklist contains five items on caregiver actions to prevent elopement (e.g. locks and alarms), four items to reduce safety risks if elopement occurs (e.g. teaching the child to cross a street safely), and 13 items to promote rapid location of the child following elopement (e.g. emergency form to provide first responders). Caregivers marked each item with yes or no to indicate if the safety measure was currently in place.</p> <hd id="AN0186601740-14">Parent target problem</hd> <p>At baseline, the IE asked the caregiver to nominate the child's top 2–3 problems (with elopement being one) and engaged the caregiver in a discussion to develop a narrative for each. Narratives described the concern including frequency, duration, and observable features as well as the impact on the child and family. The IE read the narrative back to the caregiver to confirm accuracy with edits as needed. At the midpoint and endpoint, the IE reviewed the baseline narrative and made revisions to reflect current status. The parent target problem (PTP) narratives were used by IEs to inform the Clinical Global Impression–Improvement Scale (CGI-I; [<reflink idref="bib36" id="ref35">36</reflink>]). This method has been applied in several clinical trials of behavioral interventions in autistic children ([<reflink idref="bib4" id="ref36">4</reflink>]; [<reflink idref="bib20" id="ref37">20</reflink>]; [<reflink idref="bib32" id="ref38">32</reflink>]; [<reflink idref="bib33" id="ref39">33</reflink>]).</p> <hd id="AN0186601740-15">CGI</hd> <p>At baseline, the IE (blind to treatment assignment) rated the CGI Severity scale (CGI-S; [<reflink idref="bib13" id="ref40">13</reflink>]), a seven-point scale ranging from 1 (Normal—no symptoms) to 7 (Extreme). At midpoint and endpoint, the IE rated change from baseline on the Improvement item (CGI-I). The CGI-I is a seven-point scale ranging from 1 (Very Much Improved), through 4 (No Change), to 7 (Very Much Worse). A rating of Very Much Improved or Much Improved defined positive response. In the current study, IEs were doctoral-level investigators (psychologist or BCBA-D) with several years of experience with autistic youth who elope. An expert in the use of the CGI in clinical trials (third author) trained all IEs on reliability prior to study launch and held calibration conferences throughout the trial. Training included an overview of procedures and use of CGI in past studies and scoring hypothetical cases based on participants from the pilot FBET RCT until raters agreed on CGI scores for consecutive cases. The IE used all available information for the CGI, including caregiver-completed questionnaires, caregiver-collected home data, the PTP narratives, and characterization information (e.g. age and diagnoses).</p> <hd id="AN0186601740-16">Exploratory outcome (elopement questionnaire)</hd> <p>In the absence of a validated caregiver-completed measure for elopement, we developed the 30-item Elopement Questionnaire. The structure is based on the modified Home Situations Questionnaire (HSQ) developed and validated for use in children with autism ([<reflink idref="bib9" id="ref41">9</reflink>]). On the Elopement Questionnaire, caregivers are asked to provide yes/no responses to the occurrence of potential elopement situations over the past 2 weeks. For items marked "yes," the caregiver rates the severity from 1 (mild) to 9 (severe). The questionnaire is scored by summing the severity ratings and dividing by the number of items.</p> <p>For item development, the research team reviewed past elopement literature and the PTP narratives from the pilot FBET RCT ([<reflink idref="bib33" id="ref42">33</reflink>]). The draft list was presented to a panel of four doctoral-level BCBAs with expertise in treating elopement who recommended modifications. The revised list was reviewed by the panel in a subsequent meeting, and the 30 most relevant items were agreed upon and retained. At baseline in the current study, the Elopement Questionnaire had adequate internal consistency (Cronbach's alpha = 0.93).</p> <hd id="AN0186601740-17">Acceptability and safety outcomes</hd> <p></p> <hd id="AN0186601740-18">Attendance</hd> <p>The coordinator recorded enrollment and session attendance (appointments completed divided by 12). Missed appointments successfully rescheduled were considered complete.</p> <hd id="AN0186601740-19">Treatment Acceptability Rating Form-Revised</hd> <p>FBET caregivers completed the Treatment Acceptability Rating Form-Revised (TARF-R) at the endpoint of the randomized phase ([<reflink idref="bib30" id="ref43">30</reflink>]). This measure, tailored to FBET, included 31 items rated on a seven-point scale with higher scores reflecting greater acceptability. Items include satisfaction with the treatment/program (21 items) and satisfaction with the therapist (seven items). Three items on behavior severity were excluded from analyses.</p> <hd id="AN0186601740-20">Adverse events</hd> <p>The IE completed the Safety Review Form at baseline, midpoint, and endpoint. This form includes questions about child's recent illnesses, health complaints, and medical visits and common health concerns ([<reflink idref="bib26" id="ref44">26</reflink>]). All new or worsened adverse events were documented on the Adverse Event Log whether considered related to study interventions or not (e.g. [<reflink idref="bib4" id="ref45">4</reflink>]; [<reflink idref="bib32" id="ref46">32</reflink>]). The IE rated adverse events as mild (present, but not a problem), moderate (some interference in daily life), severe (in need of intervention), or serious (need for hospitalization). The IE also recorded relatedness to the study intervention: not, unlikely, possibly, probably, or definitely related. The IE tracked adverse events in subsequent visits until resolved or the end of the trial.</p> <hd id="AN0186601740-21">Therapist training and fidelity</hd> <p>All therapists were BCBAs trained on FBET and PEP. The training included a review of manuals where the therapist and first author (supervisor) verbally read the manuals and discussed content and details of implementation. The supervisor also engaged therapists in role-play on key components. Therapists met at least every other week with the supervisor to review cases. All therapists had at least 1 year of experience in the assessment and treatment of behavioral concerns prior to initiating training for the study but were not previously exposed to FBET or PEP content.</p> <p>The supervisor observed a subset of appointments and scored therapist fidelity with a checklist of all key items that should be completed during the appointment. Fidelity was calculated by taking the items completed by the total items.</p> <hd id="AN0186601740-22">FBET procedures</hd> <p>Caregiver/child dyads met with a study therapist for 12, 2 h sessions over. Prior to COVID-19 restrictions, sessions took place in the family home or in a community setting where elopement occurred (e.g. store or park). Sessions were temporarily halted due to COVID-19. We then switched to virtual sessions with the therapist at their home or office and the family at home or in the relevant community settings. When COVID-19 restrictions relaxed, sessions were delivered in-person in the home or community or by video conference based on therapist and caregiver agreement. In total, 9 participants (FBET = 5; PEP = 4) completed treatment entirely in person, 31 (FBET = 1; PEP = 30) entirely virtual, and 28 (FBET = 26, PEP = 2) hybrid. Of those that were hybrid, 44.48% of FBET and 41.67% of PEP appointments were virtual.</p> <p>During the initial session, the FBET manual had the therapist provide caregivers with information about elopement, function-based interventions, and how to collect data using the antecedent-behavior-consequence model. In the second session, the therapist provided the caregiver with instructions on the functional analysis (described below). The therapist and the caregiver also developed a child-specific Elopement Safety Plan. The Elopement Safety Plan incorporated items not already in place based on the baseline caregiver-reported Elopement Safety Questionnaire. The therapist and caregiver documented an action plan for each item, which was reviewed and updated at subsequent sessions. The FBET manual provided guidance for developing this plan and for overcoming barriers to completing the safety items.</p> <p>For Sessions 3–4, the therapist coached the caregiver on implementing the functional analysis. The FBET manual provides protocols and graphing templates for a latency-based functional analysis in a multi-element format with 5 min sessions (see [<reflink idref="bib17" id="ref47">17</reflink>] for additional explanation on this procedure). The manual also provides guidance for modifications (e.g. synthesized conditions, increasing session length, adding idiosyncratic test conditions, conducting pairwise-matched control conditions) and example caregiver questionnaires if needed to guide assessment decisions.</p> <p>In Session 5, the therapist introduced treatment techniques based on the results of the functional analysis. The standard treatment protocol included a synchronous schedule of reinforcement ([<reflink idref="bib11" id="ref48">11</reflink>]) with a moderately preferred item (i.e. the child retained access to a preferred item so long as elopement did not occur). Treatment also included differential reinforcement of an alternative behavior (DRA; [<reflink idref="bib29" id="ref49">29</reflink>]; [<reflink idref="bib39" id="ref50">39</reflink>]), in that the caregiver provided a highly preferred stimuli (the functional reinforcer whenever possible) contingent on a defined appropriate behavior (e.g. remaining near a caregiver; a communication response for a preferred item). If safe and feasible, extinction (i.e. ensuring the functional reinforcer was withheld following elopement) was also implemented. Initially, the DRA was set at dense intervals (determined based on latency to elopement in the functional analysis), and this interval was gradually lengthened across appointments. The FBET manual also included guidance for conducting preference assessments (e.g. [<reflink idref="bib10" id="ref51">10</reflink>]).</p> <p>At subsequent sessions, the therapist coached the caregiver to implement treatment, made treatment modifications, and assigned homework for the caregiver to practice interventions between sessions. FBET included several modifications based on treatment progress. For example, if treatment was going well, the therapist might suggest reducing the frequency or magnitude of reinforcement or extending the successful techniques to new settings. If progress was stalled, the therapist might suggest altering the reinforcer or increasing the frequency of reinforcement. The FBET manual included supplemental sessions on several topics with guidelines of when to use these strategies. Supplemental sessions included least-to-most prompting, incorporating visual aids to signal reinforcement delays, token economies, time-out, managing elopement in open spaces, and child-directed play. Supplemental material was also available to facilitate the safety plan and to adapt treatment strategies for difficult settings.</p> <hd id="AN0186601740-23">PEP procedures</hd> <p>Caregivers of participants randomized to the PEP also completed 12, 1–2 h long sessions. The content was based on parent education used in control conditions in past studies ([<reflink idref="bib4" id="ref52">4</reflink>]). The first appointment included an introduction to autism, and the second focused on behavioral concerns and elopement. In this second appointment, the therapist reviewed elopement, the elopement safety checklist, and the Big Red Safety Toolkit ([<reflink idref="bib24" id="ref53">24</reflink>]). This toolkit had instructions for several items on the Elopement Safety Checklist. The therapist advised caregivers to complete the items and helped troubleshoot implementation barriers. However, the toolkit and safety items were not revisited in future appointments. This approach is similar to what is offered at a school meeting or doctor's appointment and more intensive than what most caregivers report receiving in treatment as usual for elopement ([<reflink idref="bib18" id="ref54">18</reflink>]). The remaining sessions covered understanding clinical evaluations; developmental issues; family/sibling concerns; genetics and medications; choosing effective treatments; alternative treatments; advocacy and support services; educational planning; child-directed play; and other treatment options. All sessions followed a scripted narrative that involved psychoeducation on the topic, several points of caregiver-engagement, and caregiver handouts and worksheets.</p> <hd id="AN0186601740-24">Data analysis</hd> <p>Sample size was selected based on pilot data ([<reflink idref="bib33" id="ref55">33</reflink>]). Seventy-six participants (accounting for attrition) allowed for 80% power to detect an effect size of 0.70 (α = 0.05) on the ABC-H and 80% power to detect a significant difference on the CGI-I (α = 0.05).</p> <p>All analyses were conducted in SAS version 9.4 (Cary, NC, USA); statistical significance was assessed at the 0.05 threshold. The sample was described overall and by study groups (FBET vs PEP) using frequency distributions for categorical and means and standard deviations for continuous variables. Baseline comparisons between study groups were conducted using chi-square tests of independence or Fisher's exact test for categorical variables and two-sample <emph>t</emph>-tests for continuous variables. Efficacy analyses followed intention-to-treat (ITT) principles. Continuous outcomes (ABC-H, ABC-I, Home Elopement Data, Elopement Safety Checklist, and Elopement Questionnaire) were analyzed with linear mixed models (LMMs), using all available data, and conditioned on baseline. Results are presented as raw means and standard deviations, with LMM-estimated differences in least square means (LS-means), 95% confidence intervals and <emph>p</emph>-values, and Cohen's <emph>d</emph> effect sizes at endpoint. Effect sizes were calculated by dividing endpoint LS-mean differences by corresponding pooled standard deviations at baseline and interpreted as small (0.2), moderate (0.5), and large (0.8). To test intervention efficacy on the CGI-I, a Fisher's exact test was used to compare the proportion of children showing positive response (rating of <emph>Much Improved</emph> or <emph>Very Much Improved</emph>) between groups at endpoint. By convention, participants who dropped out were classified with a negative response.</p> <p>Data are available by reasonable request from the first author.</p> <hd id="AN0186601740-25">Community involvement</hd> <p>In the pilot study of FBET ([<reflink idref="bib33" id="ref56">33</reflink>]), caregivers completed acceptability rating scales, which included a qualitative section for feedback on the study and the FBET manual. In addition, therapists from the pilot study were interviewed by the research team on issues with implementation and recommendations for manual improvement. These qualitative findings were informally summarized and reviewed by a panel of four experienced, doctoral-level behavior therapists who agreed on adaptations to the FBET manual (e.g. including additional guidelines for non-extinction-based treatments, extra troubleshooting tips for assessment and treatment) and study design (e.g. increasing the duration of treatment to account for more scheduling flexibility) in response to this feedback.</p> <hd id="AN0186601740-26">Results</hd> <p>In total, 142 caregivers completed the phone screen; 26 children were excluded as screen fails. Of the 116 remaining, parents of 29 children did not return for consent and were lost to follow-up. Parents of 87 children provided informed consent. Five participants did not attend the baseline visit. Six children, who attended the baseline visit, met exclusionary criteria. A total of 76 eligible participants completed baseline and were randomized; 38 to each group (see CONSORT diagram in Figure 1 for additional details).</p> <p>Graph: Figure 1. CONSORT diagram.*Three participants who did not receive the intended treatment completed endpoint measures and were analyzed via intent-to-treat principles.</p> <p>Participants had a mean age of 6.01 years (range = 4.0–12.8); 82.9% were male; 36.8% were Black, 34.2% White (34.2%), and 14.5% were more than one race (Table 1). Forty-five (59.2%) had an intellectual disability with a cognitive score below 70. Eighteen (23.7%) participants were on a medication for a behavioral or mental health indication.</p> <p>Table 1. Descriptive statistics of the sample.</p> <p>Graph</p> <p> <ephtml> &lt;table&gt;&lt;colgroup&gt;&lt;col align="left" /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;/colgroup&gt;&lt;thead&gt;&lt;tr&gt;&lt;th align="left"&gt;Variable&lt;/th&gt;&lt;th align="left"&gt;FBET&lt;/th&gt;&lt;th align="left"&gt;PEP&lt;/th&gt;&lt;th align="left"&gt;Total&lt;/th&gt;&lt;th align="left"&gt;&lt;italic&gt;p&lt;/italic&gt;&lt;/th&gt;&lt;/tr&gt;&lt;/thead&gt;&lt;tbody&gt;&lt;tr&gt;&lt;td&gt;Demographics&lt;/td&gt;&lt;td&gt;M (SD)&lt;/td&gt;&lt;td&gt;M (SD)&lt;/td&gt;&lt;td&gt;M (SD)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Age (years)&lt;/td&gt;&lt;td&gt;5.9 (2.0)&lt;/td&gt;&lt;td&gt;6.1 (2.0)&lt;/td&gt;&lt;td&gt;6.0 (2.0)&lt;/td&gt;&lt;td&gt;0.577&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Gender&lt;/td&gt;&lt;td&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/td&gt;&lt;td&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/td&gt;&lt;td&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Male&lt;/td&gt;&lt;td&gt;33 (86.8)&lt;/td&gt;&lt;td&gt;30 (78.9)&lt;/td&gt;&lt;td&gt;63 (82.9)&lt;/td&gt;&lt;td rowspan="2"&gt;0.361&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Female&lt;/td&gt;&lt;td&gt;5 (13.2)&lt;/td&gt;&lt;td&gt;8 (21.1)&lt;/td&gt;&lt;td&gt;13 (17.1)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Race&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Black&lt;/td&gt;&lt;td&gt;17 (44.5)&lt;/td&gt;&lt;td&gt;11 (28.9)&lt;/td&gt;&lt;td&gt;28 (36.8)&lt;/td&gt;&lt;td rowspan="5"&gt;0.001&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; White&lt;/td&gt;&lt;td&gt;13 (34.2)&lt;/td&gt;&lt;td&gt;13 (34.2)&lt;/td&gt;&lt;td&gt;26 (34.2)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Asian&lt;/td&gt;&lt;td&gt;4 (10.5)&lt;/td&gt;&lt;td&gt;6 (15.8)&lt;/td&gt;&lt;td&gt;10 (13.2)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; More than one&lt;/td&gt;&lt;td&gt;3 (7.9)&lt;/td&gt;&lt;td&gt;8 (21.1)&lt;/td&gt;&lt;td&gt;11 (14.5)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Other&lt;/td&gt;&lt;td&gt;1 (1.3)&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;1 (1.3)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Ethnicity&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Hispanic&lt;/td&gt;&lt;td&gt;4 (10.5)&lt;/td&gt;&lt;td&gt;4 (10.5)&lt;/td&gt;&lt;td&gt;8 (10.5)&lt;/td&gt;&lt;td rowspan="3"&gt;0.972&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Not Hispanic&lt;/td&gt;&lt;td&gt;32 (84.2)&lt;/td&gt;&lt;td&gt;33 (86.8)&lt;/td&gt;&lt;td&gt;65 (85.5)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Not reported&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;3 (4.0)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Total household income&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; &amp;#62;$100,001&lt;/td&gt;&lt;td&gt;5 (13.2)&lt;/td&gt;&lt;td&gt;3 (7.9)&lt;/td&gt;&lt;td&gt;8 (10.5)&lt;/td&gt;&lt;td rowspan="5"&gt;0.664&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; $60,001&amp;#8211;100,000&lt;/td&gt;&lt;td&gt;7 (18.4)&lt;/td&gt;&lt;td&gt;8 (21.1)&lt;/td&gt;&lt;td&gt;15 (19.7)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; $20,000&amp;#8211;60,000&lt;/td&gt;&lt;td&gt;12 (31.6)&lt;/td&gt;&lt;td&gt;10 (26.3)&lt;/td&gt;&lt;td&gt;22 (29.0)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; &amp;#60;$20,000&lt;/td&gt;&lt;td&gt;8 (21.1)&lt;/td&gt;&lt;td&gt;6 (15.8)&lt;/td&gt;&lt;td&gt;14 (18.4)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Not reported&lt;/td&gt;&lt;td&gt;6 (15.8)&lt;/td&gt;&lt;td&gt;11 (29.0)&lt;/td&gt;&lt;td&gt;17 (22.4)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Cognitive score&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; &amp;#10878; 85&lt;/td&gt;&lt;td&gt;8 (21.1)&lt;/td&gt;&lt;td&gt;6 (15.8)&lt;/td&gt;&lt;td&gt;14 (18.4)&lt;/td&gt;&lt;td rowspan="4"&gt;0.316&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; 70-84&lt;/td&gt;&lt;td&gt;9 (23.7)&lt;/td&gt;&lt;td&gt;8 (21.0)&lt;/td&gt;&lt;td&gt;17 (22.4)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; 50-69&lt;/td&gt;&lt;td&gt;6 (15.8)&lt;/td&gt;&lt;td&gt;13 (34.2)&lt;/td&gt;&lt;td&gt;19 (25.0)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; &amp;#60;50&lt;/td&gt;&lt;td&gt;15 (39.5)&lt;/td&gt;&lt;td&gt;11 (29.0)&lt;/td&gt;&lt;td&gt;26 (34.2)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Medications&lt;/td&gt;&lt;td&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/td&gt;&lt;td&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/td&gt;&lt;td&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Medication amount&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; 1 psychotropic&lt;/td&gt;&lt;td&gt;4 (10.5)&lt;/td&gt;&lt;td&gt;4 (10.5)&lt;/td&gt;&lt;td&gt;9 (11.8)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; 2 psychotropics&lt;/td&gt;&lt;td&gt;4 (10.5)&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;5 (6.6)&lt;/td&gt;&lt;td&gt;0.358&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; &amp;#10878;3 psychotropics&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;3 (7.9)&lt;/td&gt;&lt;td&gt;5 (6.6)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Medication type&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Methylphenidate&lt;/td&gt;&lt;td&gt;5 (13.2)&lt;/td&gt;&lt;td&gt;3 (7.9)&lt;/td&gt;&lt;td&gt;8 (10.5)&lt;/td&gt;&lt;td&gt;0.711&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Guanfacine&lt;/td&gt;&lt;td&gt;5 (13.2)&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;7 (9.2)&lt;/td&gt;&lt;td&gt;0.430&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Risperidone&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;4 (5.3)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Clonidine&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;4 (5.3)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Aripiprazole&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;3 (3.9)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Valproate&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;3 (3.9)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Fluoxetine&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;2 (2.6)&lt;/td&gt;&lt;td&gt;0.493&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Mixed amphetamine salts&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;1 (1.3)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Atomoxetine&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;1 (1.3)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Sertraline&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;1 (1.3)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Amantadine&lt;xref ref-type="table-fn" rid="tfn2"&gt;a&lt;/xref&gt;&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;1 (1.3)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Lithium&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;1 (1.3)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Dextroamphetamine&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;1 (1.3)&lt;/td&gt;&lt;td&gt;1.000&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Psychological assessments&lt;/td&gt;&lt;td&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/td&gt;&lt;td&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/td&gt;&lt;td&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;CGI&amp;#8211;severity&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Mild&lt;/td&gt;&lt;td&gt;3 (7.9)&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;5 (6.6)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Moderate&lt;/td&gt;&lt;td&gt;9 (23.7)&lt;/td&gt;&lt;td&gt;11 (28.9)&lt;/td&gt;&lt;td&gt;20 (26.3)&lt;/td&gt;&lt;td&gt;0.638&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Marked&lt;/td&gt;&lt;td&gt;24 (63.2)&lt;/td&gt;&lt;td&gt;25 (65.8)&lt;/td&gt;&lt;td&gt;49 (64.5)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Severe&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;2 (2.6)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Vineland-3&lt;/td&gt;&lt;td&gt;M (SD)&lt;/td&gt;&lt;td&gt;M (SD)&lt;/td&gt;&lt;td&gt;M (SD)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Communication&lt;/td&gt;&lt;td&gt;54.0 (20.6)&lt;/td&gt;&lt;td&gt;59.4 (17.6)&lt;/td&gt;&lt;td&gt;56.7 (19.2)&lt;/td&gt;&lt;td&gt;0.228&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Daily living skills&lt;/td&gt;&lt;td&gt;64.2 (12.3)&lt;/td&gt;&lt;td&gt;62.7 (11.4)&lt;/td&gt;&lt;td&gt;63.5 (11.8)&lt;/td&gt;&lt;td&gt;0.583&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Socialization&lt;/td&gt;&lt;td&gt;56.5 (13.6)&lt;/td&gt;&lt;td&gt;56.4 (11.4)&lt;/td&gt;&lt;td&gt;56.5 (12.5)&lt;/td&gt;&lt;td&gt;0.956&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Composite&lt;/td&gt;&lt;td&gt;58.7 (13.1)&lt;/td&gt;&lt;td&gt;60.0 (11.2)&lt;/td&gt;&lt;td&gt;59.4 (12.1)&lt;/td&gt;&lt;td&gt;0.659&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Aberrant behavior checklist&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Irritability&lt;/td&gt;&lt;td&gt;17.2 (9.5)&lt;/td&gt;&lt;td&gt;16.9 (9.0)&lt;/td&gt;&lt;td&gt;17.0 (9.2)&lt;/td&gt;&lt;td&gt;0.902&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Social withdrawal&lt;/td&gt;&lt;td&gt;12.9 (8.3)&lt;/td&gt;&lt;td&gt;11.1 (7.4)&lt;/td&gt;&lt;td&gt;12.0 (7.9)&lt;/td&gt;&lt;td&gt;0.299&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Stereotypy&lt;/td&gt;&lt;td&gt;7.1 (4.4)&lt;/td&gt;&lt;td&gt;7.3 (4.9)&lt;/td&gt;&lt;td&gt;7.2 (4.6)&lt;/td&gt;&lt;td&gt;0.844&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Hyperactivity&lt;/td&gt;&lt;td&gt;30.2 (8.9)&lt;/td&gt;&lt;td&gt;27.1 (8.7)&lt;/td&gt;&lt;td&gt;28.6 (8.8)&lt;/td&gt;&lt;td&gt;0.130&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Inappropriate speech&lt;/td&gt;&lt;td&gt;4.8 (3.5)&lt;/td&gt;&lt;td&gt;5.1 (3.4)&lt;/td&gt;&lt;td&gt;5.0 (3.5)&lt;/td&gt;&lt;td&gt;0.717&lt;/td&gt;&lt;/tr&gt;&lt;/tbody&gt;&lt;/table&gt; </ephtml> </p> <p>1 Statistics shown are <emph>n</emph> (column %) for categorical variables and mean (SD) for continuous. <emph>p</emph>-values are from Pearson's chi-square test or Fisher's exact test for categorical variables and between-group <emph>t</emph>-tests for continuous variables.</p> <p>2 Caregiver indicated that it was prescribed for anxiety.</p> <p>The elopement questionnaire was analyzed at baseline for 73 participants to describe elopement in our sample (three records were excluded due to missing data). Of the completed records, 64 (87.67%) caregivers rated elopement in at least one setting as significant severity (rating of 7 or higher) indicating frequent and severe interruption to family routines or activities; avoiding these situations/tasks as much as possible; or elopement regularly placing the child at serious risk of harm. The most common situations rated as severe were waiting in lines (<emph>N</emph> = 39; 53.42%), going to a friend's home (<emph>N</emph> = 39; 53.42%), malls or grocery stores (<emph>N</emph> = 37; 50.68%), the dentist (<emph>N</emph> = 37; 50.68%), and removing or denying access to electronics (<emph>N</emph> = 33; 45.21%).</p> <hd id="AN0186601740-27">Attrition, attendance, and fidelity</hd> <p>Two children from each group dropped out after baseline. Of these, three children returned for assessment visits. Seventy-two participants (94.7%) attended at least one treatment appointment. For participants who received some treatment, the mean number of appointments completed was 10.7 for a mean attendance of 89.3% (85.2% for FBET; 93.5% for PEP); 84.6% of participants completed all 12 appointments. Therapist fidelity was reviewed in 22.0% FBET and 20.1% PEP sessions. Mean fidelity was 95.2% (SD = 9.2) for FBET and 97.0% (SD = 6.5) for PEP.</p> <hd id="AN0186601740-28">Efficacy outcomes</hd> <p>No significant differences between FBET and PEP participants were observed on the ABC-H or ABC-I (Table 2). From baseline to endpoint, children in FBET showed significant improvements compared to PEP participants in caregiver-collected home data (<emph>p</emph> = 0.002; Effect Size [ES] = 1.04); Elopement Safety Checklist (<emph>p</emph> &lt; 0.001; ES = 1.33); and the Elopement Questionnaire (<emph>p</emph> = 0.003; ES = 0.80). On the CGI-I at endpoint, 31.6% of children in FBET were classified with positive response compared to 2.6% in PEP (<emph>p</emph> &lt; 0.001; Table 3).</p> <p>Table 2. Raw means and adjusted mean differences for outcomes at endpoint and follow-up.</p> <p>Graph</p> <p> <ephtml> &lt;table&gt;&lt;colgroup&gt;&lt;col align="left" /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;/colgroup&gt;&lt;thead&gt;&lt;tr&gt;&lt;th /&gt;&lt;th align="left"&gt;FBETRaw mean (SD)&lt;/th&gt;&lt;th align="left"&gt;PEPRaw mean (SD)&lt;/th&gt;&lt;th align="left"&gt;Baseline adjusted mean difference (95% CI)&lt;xref ref-type="table-fn" rid="tfn3"&gt;a&lt;/xref&gt;&lt;/th&gt;&lt;th align="left"&gt;&lt;italic&gt;p&lt;/italic&gt; (effect size)&lt;xref ref-type="table-fn" rid="tfn4"&gt;b&lt;/xref&gt;&lt;/th&gt;&lt;/tr&gt;&lt;/thead&gt;&lt;tbody&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Aberrant Behavior Checklist&amp;#8211;Hyperactivity&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Baseline (&lt;italic&gt;n&lt;/italic&gt; = 76)&lt;/td&gt;&lt;td&gt;30.2 (8.9)&lt;/td&gt;&lt;td&gt;27.1 (8.7)&lt;/td&gt;&lt;td&gt;&amp;#8722;&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Endpoint (&lt;italic&gt;n&lt;/italic&gt; = 66)&lt;/td&gt;&lt;td&gt;23.8 (9.5)&lt;/td&gt;&lt;td&gt;22.1 (8.2)&lt;/td&gt;&lt;td&gt;&amp;#8722;0.11 (&amp;#8722;4.02, 3.8)&lt;/td&gt;&lt;td&gt;0.955 (0.01)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Follow-up (&lt;italic&gt;n&lt;/italic&gt; = 65)&lt;/td&gt;&lt;td&gt;24.6 (10.5)&lt;/td&gt;&lt;td&gt;22.0 (9.1)&lt;/td&gt;&lt;td&gt;&amp;#8722;1.24 (&amp;#8722;5.51, 3.02)&lt;/td&gt;&lt;td&gt;0.563 (0.14)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Aberrant Behavior Checklist&amp;#8211;Irritability&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Baseline (&lt;italic&gt;n&lt;/italic&gt; = 76)&lt;/td&gt;&lt;td&gt;17.2 (9.5)&lt;/td&gt;&lt;td&gt;16.9 (9.0)&lt;/td&gt;&lt;td&gt;&amp;#8211;&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Endpoint (&lt;italic&gt;n&lt;/italic&gt; = 66)&lt;/td&gt;&lt;td&gt;13.9 (9.9)&lt;/td&gt;&lt;td&gt;14.3 (7.4)&lt;/td&gt;&lt;td&gt;0.29 (&amp;#8722;2.95, 3.52)&lt;/td&gt;&lt;td&gt;0.861 (0.03)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Follow-up (&lt;italic&gt;n&lt;/italic&gt; = 65)&lt;/td&gt;&lt;td&gt;14.7 (11.4)&lt;/td&gt;&lt;td&gt;14.1 (8.9)&lt;/td&gt;&lt;td&gt;&amp;#8722;1.55 (&amp;#8722;5.02, 1.92)&lt;/td&gt;&lt;td&gt;0.375 (0.17)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Elopement Safety Checklist&lt;xref ref-type="table-fn" rid="tfn5"&gt;c&lt;/xref&gt;&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Baseline (&lt;italic&gt;n&lt;/italic&gt; = 73)&lt;/td&gt;&lt;td&gt;22.7 (22.1)&lt;/td&gt;&lt;td&gt;26.8 (35.0)&lt;/td&gt;&lt;td&gt;&amp;#8211;&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Endpoint (&lt;italic&gt;n&lt;/italic&gt; = 65)&lt;/td&gt;&lt;td&gt;64.4 (49.0)&lt;/td&gt;&lt;td&gt;26.9 (17.3)&lt;/td&gt;&lt;td&gt;&amp;#8722;39.26 (&amp;#8722;56.97, &amp;#8722;21.55)&lt;/td&gt;&lt;td&gt;&amp;#60; 0.001 (1.33)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Follow-up (&lt;italic&gt;n&lt;/italic&gt; = 64)&lt;/td&gt;&lt;td&gt;69.6 (56.9)&lt;/td&gt;&lt;td&gt;39.7 (18.7)&lt;/td&gt;&lt;td&gt;&amp;#8722;30.31 (&amp;#8722;51.48, &amp;#8722;9.13)&lt;/td&gt;&lt;td&gt;0.006 (1.03)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Elopement Questionnaire&lt;xref ref-type="table-fn" rid="tfn5"&gt;c&lt;/xref&gt;&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Baseline (&lt;italic&gt;n&lt;/italic&gt; = 73)&lt;/td&gt;&lt;td&gt;56.3 (18.3)&lt;/td&gt;&lt;td&gt;52.1 (16.5)&lt;/td&gt;&lt;td&gt;&amp;#8211;&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Endpoint (&lt;italic&gt;n&lt;/italic&gt; = 65)&lt;/td&gt;&lt;td&gt;39.9 (22.0)&lt;/td&gt;&lt;td&gt;50.2 (19.5)&lt;/td&gt;&lt;td&gt;13.81 (5.03, 22.59)&lt;/td&gt;&lt;td&gt;0.003 (0.80)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Follow-up (&lt;italic&gt;n&lt;/italic&gt; = 63)&lt;/td&gt;&lt;td&gt;33.8 (19.4)&lt;/td&gt;&lt;td&gt;45.0 (20.6)&lt;/td&gt;&lt;td&gt;12.12 (3.04, 21.21)&lt;/td&gt;&lt;td&gt;0.010 (0.70)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="5"&gt;Home Elopement Data&lt;xref ref-type="table-fn" rid="tfn5"&gt;c&lt;/xref&gt;&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Baseline (&lt;italic&gt;n&lt;/italic&gt; = 70)&lt;/td&gt;&lt;td&gt;82.0 (24.1)&lt;/td&gt;&lt;td&gt;77.5 (22.5)&lt;/td&gt;&lt;td&gt;&amp;#8211;&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Endpoint (&lt;italic&gt;n&lt;/italic&gt; = 64)&lt;/td&gt;&lt;td&gt;42.9 (32.9)&lt;/td&gt;&lt;td&gt;66.8 (31.6)&lt;/td&gt;&lt;td&gt;24.22 (9.04, 39.4)&lt;/td&gt;&lt;td&gt;0.002 (1.04)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Follow-up (&lt;italic&gt;n&lt;/italic&gt; = 63)&lt;/td&gt;&lt;td&gt;34.1 (33.5)&lt;/td&gt;&lt;td&gt;66.2 (32.1)&lt;/td&gt;&lt;td&gt;33.81 (18.12, 49.49)&lt;/td&gt;&lt;td&gt;&amp;#60; 0.001 (1.45)&lt;/td&gt;&lt;/tr&gt;&lt;/tbody&gt;&lt;/table&gt; </ephtml> </p> <ulist> <item>3 Endpoint and follow-up LS-mean difference results-LMM include all data (baseline, midpoint, endpoint, and follow-up).</item> <item>4 Effect size interpreted using Cohen's <emph>d</emph> criteria: small (0.2), moderate (0.5), and large (0.8).</item> <item>5 Participants with missing data included to satisfy ITT. All participants were analyzed by assigned group.</item> </ulist> <p>Table 3. Endpoint and follow-up clinical global impressions-improvement scale outcomes.</p> <p>Graph</p> <p> <ephtml> &lt;table&gt;&lt;colgroup&gt;&lt;col align="left" /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;/colgroup&gt;&lt;thead&gt;&lt;tr&gt;&lt;th /&gt;&lt;th align="left" colspan="3"&gt;Endpoint&lt;/th&gt;&lt;th align="left" colspan="3"&gt;Follow-up&lt;/th&gt;&lt;/tr&gt;&lt;tr&gt;&lt;th /&gt;&lt;th align="left"&gt;FBET&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/th&gt;&lt;th align="left"&gt;PEP&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/th&gt;&lt;th align="left"&gt;&lt;italic&gt;p&lt;/italic&gt;&lt;xref ref-type="table-fn" rid="tfn6"&gt;a&lt;/xref&gt;&lt;/th&gt;&lt;th align="left"&gt;FBET&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/th&gt;&lt;th align="left"&gt;PEP&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/th&gt;&lt;th align="left"&gt;&lt;italic&gt;p&lt;/italic&gt;&lt;xref ref-type="table-fn" rid="tfn6"&gt;a&lt;/xref&gt;&lt;/th&gt;&lt;/tr&gt;&lt;/thead&gt;&lt;tbody&gt;&lt;tr&gt;&lt;td colspan="7"&gt;CGI-I&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Much or very much improved&lt;/td&gt;&lt;td&gt;12 (31.6)&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;&amp;#60; 0.001&lt;/td&gt;&lt;td&gt;19 (50.0)&lt;/td&gt;&lt;td&gt;6 (15.8)&lt;/td&gt;&lt;td rowspan="3"&gt;0.005&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Minimally improved&lt;/td&gt;&lt;td&gt;12 (31.6)&lt;/td&gt;&lt;td&gt;5 (13.2)&lt;/td&gt;&lt;td /&gt;&lt;td&gt;7 (18.4)&lt;/td&gt;&lt;td&gt;9 (23.7)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; No change&lt;/td&gt;&lt;td&gt;14 (36.8)&lt;/td&gt;&lt;td&gt;32 (84.2)&lt;/td&gt;&lt;td /&gt;&lt;td&gt;12 (31.2)&lt;/td&gt;&lt;td&gt;23 (60.5)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td colspan="7"&gt;CGI-I&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Responder&lt;xref ref-type="table-fn" rid="tfn7"&gt;b&lt;/xref&gt;&lt;/td&gt;&lt;td&gt;12 (31.6)&lt;/td&gt;&lt;td&gt;1 (2.6)&lt;/td&gt;&lt;td&gt;0.001&lt;/td&gt;&lt;td&gt;19 (50.0)&lt;/td&gt;&lt;td&gt;6 (15.8)&lt;/td&gt;&lt;td rowspan="2"&gt;0.002&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt; Non-responder&lt;xref ref-type="table-fn" rid="tfn8"&gt;c&lt;/xref&gt;&lt;/td&gt;&lt;td&gt;26 (68.4)&lt;/td&gt;&lt;td&gt;37 (97.4)&lt;/td&gt;&lt;td /&gt;&lt;td&gt;19 (50.0)&lt;/td&gt;&lt;td&gt;32 (84.2)&lt;/td&gt;&lt;/tr&gt;&lt;/tbody&gt;&lt;/table&gt; </ephtml> </p> <ulist> <item>6 Fisher's exact test measured the difference between FBET and PEP.</item> <item>7 Responder was defined as "Much Improved or Very Much Improved."</item> <item>8 Participants lost to follow-up were assumed to be non-responders.</item> </ulist> <p>Results maintained at follow-up. FBET participants showed significant improvements, compared to PEP participants, in caregiver-collected home data (<emph>p</emph> &lt; 0.001; ES = 1.45); Elopement Safety Checklist (<emph>p</emph> = 0.006; ES = 1.03); and the Elopement Questionnaire (<emph>p</emph> = 0.010; ES = 0.70). On the CGI-I at follow-up, 50% of children in FBET were classified with a positive response compared to 15.8% in PEP (<emph>p</emph> = 0.002).</p> <hd id="AN0186601740-29">Safety and acceptability</hd> <p>A total of 86 adverse events were recorded (45 in FBET; 41 in PEP). Those occurring in three or more participants are in Table 4 and are largely representative of common childhood conditions. Three adverse events in FBET participants were recorded as possibly related to the study intervention and included an increase in aggression, a leg injury that may have been related to an incident of elopement, and weight gain (possibly related to food reinforcement—an option in the FBET manual). All other adverse events were recorded as unrelated to the study.</p> <p>Table 4. Adverse events in FBET and PEP participants.</p> <p>Graph</p> <p> <ephtml> &lt;table&gt;&lt;colgroup&gt;&lt;col align="left" /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;/colgroup&gt;&lt;thead&gt;&lt;tr&gt;&lt;th align="left" rowspan="2"&gt;Adverse event type&lt;xref ref-type="table-fn" rid="tfn9"&gt;a&lt;/xref&gt;&lt;/th&gt;&lt;th align="left"&gt;FBET&lt;/th&gt;&lt;th align="left"&gt;PEP&lt;/th&gt;&lt;th align="left"&gt;Total&lt;/th&gt;&lt;/tr&gt;&lt;tr&gt;&lt;th align="left"&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/th&gt;&lt;th align="left"&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/th&gt;&lt;th align="left"&gt;&lt;italic&gt;N&lt;/italic&gt; (%)&lt;/th&gt;&lt;/tr&gt;&lt;/thead&gt;&lt;tbody&gt;&lt;tr&gt;&lt;td&gt;Cough&lt;/td&gt;&lt;td&gt;3 (7.9)&lt;/td&gt;&lt;td&gt;4 (10.5)&lt;/td&gt;&lt;td&gt;7 (9.2)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Rhinitis&lt;/td&gt;&lt;td&gt;7 (18.4)&lt;/td&gt;&lt;td&gt;3 (7.9)&lt;/td&gt;&lt;td&gt;10 (13.2)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Crying or emotional lability&lt;/td&gt;&lt;td&gt;4 (10.5)&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;6 (7.9)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Aggression&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;4 (10.5)&lt;/td&gt;&lt;td&gt;6 (7.9)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Ear infection&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;2 (5.3)&lt;/td&gt;&lt;td&gt;4 (5.3)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Property disruption&lt;/td&gt;&lt;td&gt;5 (13.2)&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;5 (6.6)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Self-injurious behavior&lt;/td&gt;&lt;td&gt;0 (0)&lt;/td&gt;&lt;td&gt;3 (7.9)&lt;/td&gt;&lt;td&gt;3 (3.8)&lt;/td&gt;&lt;/tr&gt;&lt;/tbody&gt;&lt;/table&gt; </ephtml> </p> <p>9 Includes all AEs that occurred in three or more participants.</p> <p>Twenty-nine FBET caregivers completed the TARF-R at endpoint with a mean program acceptability score of 6.03 (SD = 0.67) and therapist acceptability of 6.82 (SD = 0.58). Most caregivers (89.7%) indicated they would recommend the treatment.</p> <hd id="AN0186601740-30">Discussion</hd> <p>Results indicate that FBET is acceptable, safe, feasible to implement, and efficacious when evaluated with elopement-specific outcomes and improvements maintained at follow-up. This is the largest evaluation to date of a treatment for elopement in autistic youth. Results mostly verify the pilot RCT ([<reflink idref="bib33" id="ref57">33</reflink>]), further suggesting efficacy. This is one of only a few studies to evaluate function-based treatments in an RCT using a standardized treatment with a well-characterized sample. An advantage of FBET is the caregiver-mediated and time-limited format, which has potential as an accessible service-delivery model. Thus, this study adds significant innovation to the existing literature.</p> <p>Study outcomes set the groundwork for additional research in several ways. First, we did not identify a significant effect on our primary outcome (ABC-H), possibly due to the measure not specifically targeting elopement. The ABC-H was selected as the primary outcome given our pilot data and the dearth of validated measures specific to elopement. However, the ABC-H is not designed to capture elopement, which likely contributed to the null finding, especially given the significant findings in other outcome measures (i.e. CGI-I and elopement-specific measures). Future research should evaluate the ABC as it relates to specific topographies of behavioral concerns. The Elopement Questionnaire and Elopement Safety Checklists were designed for this line of research and are a necessary innovation given the limited evidence-based measures for elopement. It is possible these measures, combined with the CGI-I, are better primary outcomes for future elopement treatment research. However, additional study is needed to evaluate the psychometrics of these measures across settings and studies.</p> <p>A strength of the study is the measurement of adverse events, which are often not included in behavioral treatment research ([<reflink idref="bib5" id="ref58">5</reflink>]). The method used to elicit and document adverse events in this study was adapted from systems with origins in pharmacological research (e.g. [<reflink idref="bib1" id="ref59">1</reflink>]). Future trials may consider tailoring adverse event measurement systems more specifically for behavioral interventions (e.g. more detailed reporting of the child's emotional responding or loss of caregiver time/resources when implementing the intervention).</p> <p>Future research is also needed on the comparative and combined effect of FBET with other interventions. For example, medications to target hyperactivity or irritability that may be associated with elopement ([<reflink idref="bib2" id="ref60">2</reflink>]) or cognitive behavioral therapy (CBT) to target underlying anxiety that may impact elopement ([<reflink idref="bib19" id="ref61">19</reflink>]). Future research may delineate if certain diagnostic or elopement profiles are best suited for a specific type (or combination) of treatment strategies considering the potential side effects (e.g. physiological side effects of pharmaceuticals), pre-requisite skills (e.g. communication repertoire for CBT), and other presenting concerns.</p> <p>It is notable that the rate of positive responders in PEP was poorer than in past RCTs that used very similar material (e.g. [<reflink idref="bib4" id="ref62">4</reflink>]; 39.6% positive response rate in parent education). This may be related to our sample, which had more participants with cognitive impairments. This is further supported by a similar response to parent education in past samples with more cognitive impairments (e.g. [<reflink idref="bib35" id="ref63">35</reflink>]; 5.3% positive response to parent education). However, it is also possible that our IEs were more conservative in their ratings of improvement in both groups. Future research should consider incorporating experienced raters outside of the immediate research team to ensure consistency of rating the CGI-I across studies and evaluate the impact of child variables on response to parent education.</p> <p>Due to the COVID-19 pandemic, we kept any appointments that could be successfully held virtually in this format. This resulted in more virtual appointments for PEP participants compared to FBET. This may have contributed to a poorer response rate in PEP. Due to variability in the portion of appointments in person versus virtual in both groups, we were underpowered to evaluate this variable. The impact of virtual delivery of PEP and behavioral parent-training programs should be evaluated in future research.</p> <p>We included only children with autism aged 4–12 years in the study to target those most likely to elope ([<reflink idref="bib3" id="ref64">3</reflink>]). However, it is unclear if FBET is efficacious with other groups. Our sample was diverse regarding cognitive functioning, adaptive abilities, race, and household income. This is a strength, but future research should evaluate if treatment was differentially efficacious based on these variables. In addition, it is essential to evaluate the maintenance of treatment gains across time after completion of FBET.</p> <p>FBET was specifically designed for therapists with limited specialized training or experience treating elopement. However, the therapists in this trial were employed by a specialized autism clinic and received detailed training and supervision. This is typical in early efficacy RCTs to promote fidelity, but future research should focus on evaluating FBET when implemented by community-based providers without detailed oversight. The FBET manual provides detailed recommendations about treatment modifications and when to use them. Future research should explore which aspects of the manual are essential in driving positive response, especially for therapists with less specialized training.</p> <p>Further work on the development of elopement measures and refinement of FBET should incorporate stakeholder feedback, including autistic individuals. This input is crucial to ensure social validity and to promote a neurodiversity-affirming framework. This study fills several significant gaps in the literature on evidence-based interventions for elopement. Results provide evidence for efficacy and set the groundwork for important future research on elopement treatments.</p> <p>The authors acknowledge Elizabeth (Shea) Buckley and Kelly Shirley for their hard work in the implementation of the FBET and PEP protocols and Ansley Reich for her assistance in study oversight.</p> <ref id="AN0186601740-31"> <title> References </title> <blist> <bibl id="bib1" idref="ref59" type="bt">1</bibl> <bibtext> Aman M. G., Arnold M. L., Eugene McDougle C. J., Vitiello B., Scahill L., Davies M., McCracken J. T., Tierney E., Nash P. L., Posey D. J. (2005). Acute and long-term safety and tolerability of risperidone in children with autism. Journal of Child &amp; Adolescent Psychopharmacology, 15(6), 869–884.</bibtext> </blist> <blist> <bibl id="bib2" idref="ref60" type="bt">2</bibl> <bibtext> Andersen A. M., Law J. K., Marvin A. R., Lipkin P. H. (2020). Elopement patterns and caregiver strategies. 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Journal of Applied Behavior Analysis, 53(3), 1299–1303. https://doi.org/10.1002/jaba.701</bibtext> </blist> </ref> <ref id="AN0186601740-32"> <title> Footnotes </title> <blist> <bibtext> Mindy Scheithauer: Conceptualization; Data curation; Formal analysis; Funding acquisition; Investigation; Methodology; Project administration; Supervision; Validation; Visualization; Writing—original draft; Writing—review &amp; editing.Joanna Lomas Mevers: Conceptualization; Methodology; Validation; Writing—review &amp; editing.Lawrence Scahill: Conceptualization; Data curation; Investigation; Methodology; Supervision; Writing—review &amp; editing.Sarah Slocum Freeman: Conceptualization; Investigation; Validation.Colin Muething: Conceptualization; Investigation; Validation.Chelsea Rock: Data curation; Investigation; Project administration; Validation; Writing—original draft.Scott Gillespie: Conceptualization; Formal analysis; Validation; Writing—original draft; Writing—review &amp; editing.Laura Johnson: Formal analysis; Validation; Writing—review &amp; editing.Nathan Call: Conceptualization; Data curation; Funding acquisition; Investigation; Methodology; Supervision; Writing—review &amp; editing.</bibtext> </blist> <blist> <bibtext> The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.</bibtext> </blist> <blist> <bibtext> The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by an Autism Speaks Treatment Grant; authors received grant funding from this organization. Some of the authors work in an autism clinic and use behavioral treatments in their clinical responsibilities.</bibtext> </blist> <blist> <bibtext> Website: https://clinicaltrials.gov/study/NCT03899831?titles=elopement&amp;rank=1#study-overview. Trial name: A Caregiver-Mediated Function-Based Elopement Treatment for Autistic Children: A Randomized Controlled Trial. Trial number: NCT0389983.</bibtext> </blist> <blist> <bibtext> Mindy Scheithauer</bibtext> </blist> <blist> <bibtext>Graph</bibtext> </blist> <blist> <bibtext>https://orcid.org/0000-0002-0775-1013 Lawrence Scahill</bibtext> </blist> <blist> <bibtext>Graph https://orcid.org/0000-0001-5073-1707</bibtext> </blist> </ref> <aug> <p>By Mindy Scheithauer; Joanna Lomas Mevers; Lawrence Scahill; Sarah Slocum Freeman; Colin Muething; Chelsea Rock; Scott Gillespie; Laura Johnson and Nathan Call</p> <p>Reported by Author; Author; Author; Author; Author; Author; Author; Author; Author</p> </aug> <nolink nlid="nl1" bibid="bib25" firstref="ref1"></nolink> <nolink nlid="nl2" bibid="bib18" firstref="ref2"></nolink> <nolink nlid="nl3" bibid="bib22" firstref="ref6"></nolink> <nolink nlid="nl4" bibid="bib17" firstref="ref9"></nolink> <nolink nlid="nl5" bibid="bib33" firstref="ref10"></nolink> <nolink nlid="nl6" bibid="bib15" firstref="ref12"></nolink> <nolink nlid="nl7" bibid="bib37" firstref="ref13"></nolink> <nolink nlid="nl8" bibid="bib28" firstref="ref17"></nolink> <nolink nlid="nl9" bibid="bib27" firstref="ref19"></nolink> <nolink nlid="nl10" bibid="bib14" firstref="ref20"></nolink> <nolink nlid="nl11" bibid="bib40" firstref="ref21"></nolink> <nolink nlid="nl12" bibid="bib21" firstref="ref23"></nolink> <nolink nlid="nl13" bibid="bib34" firstref="ref24"></nolink> <nolink nlid="nl14" bibid="bib31" firstref="ref25"></nolink> <nolink nlid="nl15" bibid="bib12" firstref="ref26"></nolink> <nolink nlid="nl16" bibid="bib23" firstref="ref27"></nolink> <nolink nlid="nl17" bibid="bib38" firstref="ref28"></nolink> <nolink nlid="nl18" bibid="bib16" firstref="ref29"></nolink> <nolink nlid="nl19" bibid="bib24" firstref="ref34"></nolink> <nolink nlid="nl20" bibid="bib36" firstref="ref35"></nolink> <nolink nlid="nl21" bibid="bib20" firstref="ref37"></nolink> <nolink nlid="nl22" bibid="bib32" firstref="ref38"></nolink> <nolink nlid="nl23" bibid="bib13" firstref="ref40"></nolink> <nolink nlid="nl24" bibid="bib30" firstref="ref43"></nolink> <nolink nlid="nl25" bibid="bib26" firstref="ref44"></nolink> <nolink nlid="nl26" bibid="bib11" firstref="ref48"></nolink> <nolink nlid="nl27" bibid="bib29" firstref="ref49"></nolink> <nolink nlid="nl28" bibid="bib39" firstref="ref50"></nolink> <nolink nlid="nl29" bibid="bib10" firstref="ref51"></nolink> <nolink nlid="nl30" bibid="bib19" firstref="ref61"></nolink> <nolink nlid="nl31" bibid="bib35" firstref="ref63"></nolink> |
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| Items | – Name: Title Label: Title Group: Ti Data: A Randomized Trial of Caregiver-Mediated Function-Based Elopement Treatment for Autistic Children – Name: Language Label: Language Group: Lang Data: English – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Mindy+Scheithauer%22">Mindy Scheithauer</searchLink> (ORCID <externalLink term="https://orcid.org/0000-0002-0775-1013">0000-0002-0775-1013</externalLink>)<br /><searchLink fieldCode="AR" term="%22Joanna+Lomas+Mevers%22">Joanna Lomas Mevers</searchLink><br /><searchLink fieldCode="AR" term="%22Lawrence+Scahill%22">Lawrence Scahill</searchLink> (ORCID <externalLink term="https://orcid.org/0000-0001-5073-1707">0000-0001-5073-1707</externalLink>)<br /><searchLink fieldCode="AR" term="%22Sarah+Slocum+Freeman%22">Sarah Slocum Freeman</searchLink><br /><searchLink fieldCode="AR" term="%22Colin+Muething%22">Colin Muething</searchLink><br /><searchLink fieldCode="AR" term="%22Chelsea+Rock%22">Chelsea Rock</searchLink><br /><searchLink fieldCode="AR" term="%22Scott+Gillespie%22">Scott Gillespie</searchLink><br /><searchLink fieldCode="AR" term="%22Laura+Johnson%22">Laura Johnson</searchLink><br /><searchLink fieldCode="AR" term="%22Nathan+Call%22">Nathan Call</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="SO" term="%22Autism%3A+The+International+Journal+of+Research+and+Practice%22"><i>Autism: The International Journal of Research and Practice</i></searchLink>. 2025 29(8):1973-1986. – Name: Avail Label: Availability Group: Avail Data: SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: https://sagepub.com – Name: PeerReviewed Label: Peer Reviewed Group: SrcInfo Data: Y – Name: Pages Label: Page Count Group: Src Data: 14 – Name: DatePubCY Label: Publication Date Group: Date Data: 2025 – Name: TypeDocument Label: Document Type Group: TypDoc Data: Journal Articles<br />Reports - Research – Name: Audience Label: Education Level Group: Audnce Data: <searchLink fieldCode="EL" term="%22Adult+Education%22">Adult Education</searchLink> – Name: Subject Label: Descriptors Group: Su Data: <searchLink fieldCode="DE" term="%22Behavior+Problems%22">Behavior Problems</searchLink><br /><searchLink fieldCode="DE" term="%22Children%22">Children</searchLink><br /><searchLink fieldCode="DE" term="%22Preadolescents%22">Preadolescents</searchLink><br /><searchLink fieldCode="DE" term="%22Autism+Spectrum+Disorders%22">Autism Spectrum Disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Program+Effectiveness%22">Program Effectiveness</searchLink><br /><searchLink fieldCode="DE" term="%22Parent+Education%22">Parent Education</searchLink><br /><searchLink fieldCode="DE" term="%22Parent+Role%22">Parent Role</searchLink><br /><searchLink fieldCode="DE" term="%22Intervention%22">Intervention</searchLink><br /><searchLink fieldCode="DE" term="%22Functional+Behavioral+Assessment%22">Functional Behavioral Assessment</searchLink><br /><searchLink fieldCode="DE" term="%22Safety%22">Safety</searchLink> – Name: SubjectThesaurus Label: Assessment and Survey Identifiers Group: Su Data: <searchLink fieldCode="SU" term="%22Aberrant+Behavior+Checklist%22">Aberrant Behavior Checklist</searchLink><br /><searchLink fieldCode="SU" term="%22Autism+Diagnostic+Observation+Schedule%22">Autism Diagnostic Observation Schedule</searchLink><br /><searchLink fieldCode="SU" term="%22Childhood+Autism+Rating+Scale%22">Childhood Autism Rating Scale</searchLink> – Name: DOI Label: DOI Group: ID Data: 10.1177/13623613251330388 – Name: ISSN Label: ISSN Group: ISSN Data: 1362-3613<br />1461-7005 – Name: Abstract Label: Abstract Group: Ab Data: Elopement is a common and dangerous behavior among autistic children. Behavioral treatments can reduce elopement, but most evidence comes from small-N evaluations in specialized settings with strategies varying across studies. The current study compared the efficacy of the caregiver-mediated function-based elopement treatment to parent education program (PEP) in a 16-week randomized clinical trial of 76 autistic children (age = 4-12 years). Function-based elopement treatment involves 12 weekly appointments aimed at improving safety, identifying the function of elopement, and implementing subsequent function-based treatment strategies. No group differences were observed on the Aberrant Behavior Checklist-Hyperactivity (primary outcome). Significant improvement from baseline to endpoint in function-based elopement treatment compared to parent education program participants was observed for secondary outcomes, including caregiver ratings of safety measures (p < 0.01), severity of elopement based on the Elopement Questionnaire (p < 0.01), and caregiver-collected data on elopement (p < 0.01). The Clinical Global Impression--Improvement Scale (CGI-I) rated by a treatment-blind evaluator found 31.6% of function-based elopement treatment participants improved compared to 2.6% in parent education program (p = 0.001). Improvements were maintained at a 28-week follow-up. Attrition was 5.26%, and no significant adverse events were deemed related to treatment. Function-based elopement treatment was superior to parent education program on elopement-specific outcomes and appears safe and acceptable. – Name: AbstractInfo Label: Abstractor Group: Ab Data: As Provided – Name: DateEntry Label: Entry Date Group: Date Data: 2025 – Name: AN Label: Accession Number Group: ID Data: EJ1476855 |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1177/13623613251330388 Languages: – Text: English PhysicalDescription: Pagination: PageCount: 14 StartPage: 1973 Subjects: – SubjectFull: Behavior Problems Type: general – SubjectFull: Children Type: general – SubjectFull: Preadolescents Type: general – SubjectFull: Autism Spectrum Disorders Type: general – SubjectFull: Program Effectiveness Type: general – SubjectFull: Parent Education Type: general – SubjectFull: Parent Role Type: general – SubjectFull: Intervention Type: general – SubjectFull: Functional Behavioral Assessment Type: general – SubjectFull: Safety Type: general – SubjectFull: Aberrant Behavior Checklist Type: general – SubjectFull: Autism Diagnostic Observation Schedule Type: general – SubjectFull: Childhood Autism Rating Scale Type: general Titles: – TitleFull: A Randomized Trial of Caregiver-Mediated Function-Based Elopement Treatment for Autistic Children Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Mindy Scheithauer – PersonEntity: Name: NameFull: Joanna Lomas Mevers – PersonEntity: Name: NameFull: Lawrence Scahill – PersonEntity: Name: NameFull: Sarah Slocum Freeman – PersonEntity: Name: NameFull: Colin Muething – PersonEntity: Name: NameFull: Chelsea Rock – PersonEntity: Name: NameFull: Scott Gillespie – PersonEntity: Name: NameFull: Laura Johnson – PersonEntity: Name: NameFull: Nathan Call IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 08 Type: published Y: 2025 Identifiers: – Type: issn-print Value: 1362-3613 – Type: issn-electronic Value: 1461-7005 Numbering: – Type: volume Value: 29 – Type: issue Value: 8 Titles: – TitleFull: Autism: The International Journal of Research and Practice Type: main |
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