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A Feasibility Randomized Clinical Trial of a Structured Function-Based Intervention for Elopement in Children with Autism Spectrum Disorder

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Title: A Feasibility Randomized Clinical Trial of a Structured Function-Based Intervention for Elopement in Children with Autism Spectrum Disorder
Language: English
Authors: Scheithauer, Mindy (ORCID 0000-0002-0775-1013), Call, Nathan A., Lomas Mevers, Joanna, McCracken, Courtney E., Scahill, Lawrence
Source: Journal of Autism and Developmental Disorders. Aug 2021 51(8):2866-2875.
Availability: Springer. Available from: Springer Nature. One New York Plaza, Suite 4600, New York, NY 10004. Tel: 800-777-4643; Tel: 212-460-1500; Fax: 212-460-1700; e-mail: customerservice@springernature.com; Web site: https://link.springer.com/
Peer Reviewed: Y
Page Count: 10
Publication Date: 2021
Sponsoring Agency: National Institutes of Health (DHHS)
Document Type: Journal Articles
Reports - Research
Descriptors: Randomized Controlled Trials, Intervention, Behavior Problems, Children, Autism, Pervasive Developmental Disorders, Check Lists, Behavior Modification, Outcomes of Treatment, Guides
Assessment and Survey Identifiers: Aberrant Behavior Checklist
DOI: 10.1007/s10803-020-04753-4
ISSN: 0162-3257
Abstract: Elopement is a common and dangerous concern in autism spectrum disorder (ASD). There is evidence that behavior analytic treatments can successfully treat elopement, but the research is limited due to small samples and treatment components varying across studies. The current study evaluated the feasibility of studying a manualized intervention for elopement, based on strategies from single-subject research, in a randomized clinical trial with 24 individuals with ASD. Results demonstrated that recruitment was feasible; the manual was acceptable to parents; and therapists followed the manual with high-integrity. Initial efficacy results measured by the Aberrant Behavior Checklist, Clinical Global Impression Scale, and a Home Elopement Safety Checklist suggested improvement in the treatment group that should be studied in future research.
Abstractor: As Provided
Entry Date: 2021
Accession Number: EJ1302629
Database: ERIC
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  Value: <anid>AN0151229727;aut01aug.21;2021Jul06.02:55;v2.2.500</anid> <title id="AN0151229727-1">A Feasibility Randomized Clinical Trial of a Structured Function-Based Intervention for Elopement in Children with Autism Spectrum Disorder </title> <p>Elopement is a common and dangerous concern in autism spectrum disorder (ASD). There is evidence that behavior analytic treatments can successfully treat elopement, but the research is limited due to small samples and treatment components varying across studies. The current study evaluated the feasibility of studying a manualized intervention for elopement, based on strategies from single-subject research, in a randomized clinical trial with 24 individuals with ASD. Results demonstrated that recruitment was feasible; the manual was acceptable to parents; and therapists followed the manual with high-integrity. Initial efficacy results measured by the Aberrant Behavior Checklist, Clinical Global Impression Scale, and a Home Elopement Safety Checklist suggested improvement in the treatment group that should be studied in future research.</p> <p>Keywords: Autism spectrum disorder; Elopement; Applied behavior analysis; Treatment; Intervention; Randomized clinical trial</p> <p>The most recent publication from the Centers for Disease Control reports that autism spectrum disorder (ASD) affects 18.5 per 1000 school-age children (Maenner et al. [<reflink idref="bib24" id="ref1">24</reflink>]). The defining features of ASD include impaired social communication, repetitive behavior, and restricted interests (American Psychiatric Association [<reflink idref="bib3" id="ref2">3</reflink>]). Children with ASD also exhibit a wide range of behavioral problems including elopement, hyperactivity, aggression, tantrums, self-injury, and noncompliance (Soke et al. [<reflink idref="bib38" id="ref3">38</reflink>], [<reflink idref="bib37" id="ref4">37</reflink>]).</p> <p>Leaving adult supervision, also called elopement, is among the most challenging behaviors exhibited by children with ASD. Some children with ASD wander off without destination, while others may be highly fixated on a specific destination or object. Pursuit of that interest may cause the child to bolt to a toy aisle in a store, across a parking lot, or even into traffic. Based on caregiver report, 49% to 68% of children with ASD have a history of elopement (Anderson et al. [<reflink idref="bib5" id="ref5">5</reflink>]; Pereira-Smith et al. [<reflink idref="bib29" id="ref6">29</reflink>]), with 27% eloping in the last year (Kiely et al. [<reflink idref="bib20" id="ref7">20</reflink>]). Not surprisingly, caregivers of children with ASD describe elopement as an extremely stressful event (Anderson et al. [<reflink idref="bib5" id="ref8">5</reflink>]; National Autism Association [NAA], [<reflink idref="bib26" id="ref9">26</reflink>]; Woodard [<reflink idref="bib39" id="ref10">39</reflink>]).</p> <p>The danger of elopement is amplified in children with language and cognitive delays. Language delays may limit the child's ability to provide identifying information after becoming lost; increasing the time it takes to find the caregiver. Additionally, children who cannot effectively communicate vocally are at risk of exhibiting aggression and other disruptive behaviors along with elopement (Fitzpatrick et al. [<reflink idref="bib16" id="ref11">16</reflink>]), exacerbating the difficulty of the situation. Cognitive delays may limit the child's ability to navigate dangerous circumstances. For example, a child with a cognitive delay may not have important skills to maintain safety following an elopement incident, such as the ability to cross a street or the knowledge to avoid water if the child does not know how to swim. As such, elopement in ASD can be associated with profoundly detrimental outcomes, including injury and death due to traffic accidents, drowning, and exposure to weather (Anderson et al. [<reflink idref="bib5" id="ref12">5</reflink>]; NAA [<reflink idref="bib26" id="ref13">26</reflink>]).</p> <p>Tools that include prevention strategies targeting elopement are available to parents (e.g., Andersen et al. [<reflink idref="bib4" id="ref14">4</reflink>]; Center for Disease Control and Prevention [<reflink idref="bib11" id="ref15">11</reflink>]; NAA [<reflink idref="bib25" id="ref16">25</reflink>]; Pereira-Smith et al. [<reflink idref="bib29" id="ref17">29</reflink>]). Examples include installing locks on doors, teaching safety skills (e.g., crossing a street safely, encouraging children to learn their phone number and address, learning to swim, etc.). Interventions may also establish strategies for a missing child in advance of an elopement event (NAA [<reflink idref="bib25" id="ref18">25</reflink>]; NAA [<reflink idref="bib26" id="ref19">26</reflink>]). These prevention strategies are important as they may decrease the probability of elopement or mitigate the risk of harm if it does occur. However, they may not constitute a complete treatment plan for children who show repeated elopement attempts because they may not address the underlying behavioral mechanisms causing persistent elopement.</p> <p>Treatments based in applied behavior analysis (ABA) have been shown to decrease elopement attempts in children with ASD in single-subject demonstrations (Boyle and Adamson [<reflink idref="bib8" id="ref20">8</reflink>]; Lang et al. [<reflink idref="bib22" id="ref21">22</reflink>]) and a review of clinical case records (Call et al. [<reflink idref="bib10" id="ref22">10</reflink>]). These treatments are guided by a <emph>functional analysis</emph> (Iwata et al. [<reflink idref="bib18" id="ref23">18</reflink>]) designed to identify the reinforcers that maintain elopement. This assessment is key to understanding the reason behind the child's behavior (Hanley et al. [<reflink idref="bib17" id="ref24">17</reflink>]). In a functional analysis of elopement, situations are arranged that are likely to evoke elopement and potential reinforcers are provided following elopement. For example, some children may elope while on a shopping trip when specific toys come into view because they want access to the toys. To test this, the therapist might restrict access to specific toys and observe if the child will elope to gain access to these toys. If elopement occurs at high rates in this condition compared to times when toys are freely available, it suggests elopement occurs to gain access to these items. Other test conditions are designed to evaluate if elopement occurs to get adult attention (e.g., to get a parent to chase him/her) or to escape nonpreferred tasks (e.g., eloping out of the house to avoid doing homework). Finally, there are conditions to test whether elopement is automatically maintained (i.e., the act of running is self-reinforcing). See Boyle and Adamson ([<reflink idref="bib8" id="ref25">8</reflink>]) for a thorough description of functional analyses of elopement.</p> <p>Information from the functional analysis is used to develop an individualized treatment plan that includes teaching the child alternative ways to access the same reinforcer(s) (e.g., toys, attention, or escape). The combination of reinforcing the alternative behaviors and withholding reinforcement following elopement (i.e., extinction) are applied to reduce the frequency of the maladaptive behavior.</p> <p>While this treatment approach has been shown effective in multiple evaluations (e.g., Boyle et al. [<reflink idref="bib9" id="ref26">9</reflink>]; Lang et al. [<reflink idref="bib21" id="ref27">21</reflink>]; Piazza et al. [<reflink idref="bib30" id="ref28">30</reflink>]), there are several limitations in the treatment literature. First, published interventions are highly individualized and have been primarily evaluated in specialized facilities with clinical teams that specialize in the treatment of challenging behavior (Call et al. [<reflink idref="bib10" id="ref29">10</reflink>]; Lang et al. [<reflink idref="bib22" id="ref30">22</reflink>]). Research extending these techniques to a wider range of settings (e.g., homes, community settings) has been limited to a few studies (Boyle and Adamson [<reflink idref="bib8" id="ref31">8</reflink>]). In addition, compared to the well-trained clinical teams that often publish research in this area, clinicians in community-based treatment settings may not have sufficient experience with functional analyses to complete them effectively (Oliver et al. [<reflink idref="bib28" id="ref32">28</reflink>]). Last, most studies have not reported on the involvement of parents in treatment, an important step to promote maintenance of treatment gains.</p> <p>The Function Based Elopement Treatment (FBET) manual was developed to address these gaps in the literature and increase the likelihood that community-based providers have the resources necessary to conduct function-based treatments for elopement. This manual provides instructions, decision trees, and guidance on conducting a functional analysis for elopement in a home or community setting. The FBET manual also provides guidance for selecting treatment components and provides scripting for parent training to promote a parent-mediated method of delivery. In addition, the manual includes prevention strategies highlighted in past resources. The current study evaluated the feasibility of this structured treatment. Outcomes focus on (a) ability to recruit and retain participants; (b) acceptability of the intervention and study procedures by parents; and (c) the degree to which clinicians implement the treatment with fidelity. Results also present the preliminary efficacy of the intervention. This feasibility trial is a necessary precursor to large-scale efficacy trials (Smith et al. [<reflink idref="bib36" id="ref33">36</reflink>]).</p> <hd id="AN0151229727-2">Method</hd> <p></p> <hd id="AN0151229727-3">Design</hd> <p>The study was a 12-week randomized trial. Eligible participants were randomly assigned to treatment with FBET or waitlist using permuted blocks with allocation patterns concealed to investigators. Study participants were scheduled to complete outcome measures (described below) at baseline, mid-point (6 weeks post baseline), and end-point (12 weeks post baseline). At Week 12, participants in the waitlist group were offered FBET.</p> <hd id="AN0151229727-4">Setting and Participants</hd> <p>Recruitment methods included fliers and referrals from providers (e.g., medical personnel and ABA therapists) at an outpatient ASD clinic in the southeast United States. Researchers also contacted parents of children on an ABA clinic waitlist with a complaint of elopement. Boys and girls between 4 and 12 years of age with a diagnosis of ASD and a parent report of elopement were included. Children with other behavioral challenges that required treatment prior to targeting elopement, those currently receiving behavioral treatment for elopement (or planning to start in the next 6 months), and participants with planned medication changes were excluded. If caregivers reported other behavioral concerns, the researcher asked follow-up questions regarding the type, frequency/duration, and impact (e.g., injuries, environmental damage) of the behavior. The researcher presented this information to at least three doctoral level Board Certified Behavior Analysts (BCBA-D) that specialized in the treatment of challenging behavior and a determination was made as to if the other challenging behaviors should be targeted prior to treating elopement. The investigators came to a unanimous consensus for each case presented, but a voting system was in the protocol for the study if this were not the case. Parents were asked not to initiate any new treatments during the study period. The researcher also asked caregivers if they could reliably attend appointments at the same time each week for 10 weeks between the hours of 8:30 and 5:30. Children of caregivers who reported they could not reliably attend appointments were excluded.</p> <p>Enrollment began with a parent phone interview to describe the purpose of the study and to screen the child for eligibility. Participants who appeared eligible were invited for formal assessment. The assessment included informed consent, the Autism Diagnostic Observation Schedule (ADOS; Lord et al. [<reflink idref="bib23" id="ref34">23</reflink>]), Stanford-Binet 5 (Roid [<reflink idref="bib34" id="ref35">34</reflink>]), Vineland Adaptive Behavior Scale, and a parent interview to confirm eligibility.</p> <hd id="AN0151229727-5">Feasibility Measures</hd> <p>Measures of feasibility included: refusal by parent of presumably eligible participants, attrition, session attendance, successful data collection, therapist reliability, and parental adherence. Each of these metrics had a preset benchmark expressed as a percentage. Calculation of refusal rate was a percentage of participants who were contacted about the study and appeared eligible but did not consent (target ≤ 20% refusal). The benchmark for attrition was set at ≤ 15%, measured by participants who were randomized, but did not complete endpoint. An appointment log kept by the therapist measured session attendance through the percentage of appointments completed out of the targeted 10 appointments (target ≥ 85% attendance). The benchmark for measure completion was set at ≥ 90% completed, measured by the percentage of primary outcome measures returned at baseline, midpoint, and endpoint for all participants consented.</p> <p>An investigator attended at least 20% of appointments for each participant, distributing attendance across appointments so each appointment (1–10) was evaluated across participants. A list of items was generated for each appointment that included the essential elements for that session. The investigator observed the therapist and recorded whether each task was completed correctly or incorrectly. The integrity score was based on the percentage of items marked as correct over all possible items, averaged across appointments (target integrity ≥ 90%).</p> <p>At the completion of each appointment, therapists rated caregiver completion of tasks assigned to them at the prior visit and tasks the therapist asked the caregiver to complete during the appointment as a measure of caregiver integrity. For example, in an appointment focused on reviewing functions of elopement, an integrity item addressed whether caregivers accurately identified examples of behaviors maintained by various reinforcers (i.e., why the behavior in the examples occurred). Other items addressed if caregivers practiced treatment accurately and collected data between appointments. The therapist marked items as "complete" or "incomplete", used to calculate a percentage of items completed (target caregiver integrity ≥ 80%).</p> <p>The TARF-R (Reimers and Wacker [<reflink idref="bib31" id="ref36">31</reflink>]) targeted acceptability of FBET. This questionnaire is a 31-item measure, measuring acceptability of the treatment program and the therapist. Caregivers rated each question on a 7-point scale with anchors varying based on the question. The total score is the sum of all items divided by the maximum score possible multiplied by 100. Thus, a score of 100% indicates that each item was marked as the most acceptable. The content of the measure was modified for this study to reflect the FBET intervention. Our targeted TARF-R score was ≥ 80%.</p> <hd id="AN0151229727-6">Efficacy Measures</hd> <p>The below measures were completed at baseline, midpoint, and endpoint.</p> <hd id="AN0151229727-7">Aberrant Behavior Checklist (ABC)</hd> <p>The ABC (Aman et al. [<reflink idref="bib2" id="ref37">2</reflink>]) is a 58-item parent report measure assessing a range of maladaptive behaviors (Bearss et al. [<reflink idref="bib7" id="ref38">7</reflink>]). The measure includes five subscales: Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactivity, and Inappropriate Speech. Items are rated zero to three with higher scores indicating greater severity. Interpretation of scores is aided by normative data in youth with ASD (Kaat et al. [<reflink idref="bib19" id="ref39">19</reflink>]). The Irritability (ABC-I) and Hyperactivity (ABC-H) subscales were most relevant for a behavioral treatment of elopement.</p> <hd id="AN0151229727-8">Parenting Stress Index—Short Form (PSI)</hd> <p>The PSI is a 36-item parent self-report questionnaire measuring parental impressions and difficulties in the parenting role. PSI reliability and validity are well-established in several pediatric clinical populations (Abidin [<reflink idref="bib1" id="ref40">1</reflink>]). The measure consists of three, 12-item subscales: Parental Distress (PD; burdens in the parenting role); Parent–Child Dysfunctional Interaction (P-CDI; dissatisfaction with the parent–child relationship); and Difficult Child (DC; child behaviors that are challenging for the parent).</p> <hd id="AN0151229727-9">Home Elopement Safety Checklist (HESC)</hd> <p>The HESC is a 22-item measure developed for this study to assess preventative measures to reduce the likelihood of elopement (e.g., locks on doors) and caregiver readiness to manage episodes of elopement (e.g., organizing a search group). It also includes a list of skills that may reduce the danger if elopement occurs (e.g., teaching the child how to cross streets or report his or her phone number). Caregivers reviewed each item and selected "yes" if the item was present and "no" if the item was not present. The score is a percentage of items endorsed as "yes".</p> <p>Three BCBA-D investigators with extensive experience in the assessment and treatment of elopement developed the measure based on experiences working with children who elope. Recommendations regarding elopement safety in pre-existing parent resources (NAA [<reflink idref="bib25" id="ref41">25</reflink>]) also guided the development of several items. An evaluation of the reliability of the HESC using a standardized Cronbach alpha of all measures completed at baseline (N = 23), resulted in high internal consistency (Cronbach α = 0.84).</p> <hd id="AN0151229727-10">Parent Target Problems (PTP)</hd> <p>PTPs are brief narratives designed to capture the child's two most pressing problems (Arnold et al. [<reflink idref="bib6" id="ref42">6</reflink>]; Scahill et al. [<reflink idref="bib35" id="ref43">35</reflink>]). Using a semi-structured interview, a research coordinator, blind to treatment assignment, met with the caregiver at baseline to generate the PTP. The interview focused on behavioral descriptions such as the frequency and duration of problems such as elopement, as well as the impact on the child and family. The research coordinator created a paragraph summarizing the conversation and read this back to the caregiver to refine the description. At midpoint and endpoint, the coordinator met with the parent to revise the narrative to reflect current behavior.</p> <hd id="AN0151229727-11">Clinical Global Impression—Improvement Scale (CGI-I)</hd> <p>The CGI-I is a seven-point scale designed to measure change from baseline (Bearss et al. [<reflink idref="bib7" id="ref44">7</reflink>]). Using all available information (all measures described above), the CGI-I is rated from one (Very Much Improved) through four (No Change) to seven (Very Much Worse). By convention, scores of one (Very Much Improved) and two (Much Improved) define positive response. Scores of three (Minimally Improved) and lower indicated no improvement (Bearss et al. [<reflink idref="bib7" id="ref45">7</reflink>]; Research Units on Pediatric Psychopharmacology [<reflink idref="bib32" id="ref46">32</reflink>]). At the completion of the study, two experienced, blinded clinicians independently evaluated the PTP narratives and all other available information (e.g., ABC, PSI, HESC) to score the CGI-I. Disagreement on classification of positive or negative response on the CGI-I were resolved by consensus.</p> <hd id="AN0151229727-12">Treatment Protocol</hd> <p>The treatment included ten, two-hour appointments, over the course of 12 weeks. Therapists were Board Certified Behavior Analysts (BCBAs) and all appointments were conducted in the home or community settings (e.g., store, park, church).</p> <p>The treatment manual followed a decision tree with different protocols based on the child's clinical presentation. There were two protocols in the manual, classified as bolting or wandering. In a parental interview during screening, the research coordinator asked the caregiver several questions about the child's elopement. Three members of the research team (all BCBA-D) with extensive experience in the treatment of elopement reviewed the information from the interview and classified the elopement as bolting or wandering.</p> <p>Bolting was applied to children who frequently ran from adult supervision and/or eloped even when closely supervised (e.g., walking next to a caregiver while holding hands and bolting towards the playground). Bolting captured elopement towards a clear destination or away from a nonpreferred setting (i.e., there was a clear environmental event that preceded and/or followed elopement). Wandering was applied to children who primarily eloped during times of low supervision. For example, a child who leaves the house in the middle of the night or walks away from the classroom when the teacher is distracted. Wandering classification captured elopement with no clear surrounding environmental events. These distinctions were based on the assumption that bolting elopement is likely maintained by consequences under the control of another person (i.e., socially-maintained) and the source of reinforcement for wandering may be nonsocial (i.e., automatically maintained) or difficult to determine in an abbreviated assessment.</p> <p>While the initial classification occurred at screening, therapists switched protocols based on information from assessment and treatment. A child classified as a wanderer switched to the bolting protocol if data collected from the caregiver indicated clear environmental antecedents or consequences to elopement. Similarly, a child classified as a bolter switched to the wandering protocol if a clear function was not identified in the functional analysis.</p> <p>A brief overview of each appointment is included below. A more detailed description of the manual is available from the first author.</p> <hd id="AN0151229727-13">Bolting & Wandering Appointment 1- 2: Psychoeducation and Home Elopement Safety Plan</hd> <p>In the first appointment for both protocols, the therapist described elopement, the antecedent-behavior-consequence paradigm, and the concepts of reinforcement and extinction. Caregivers recorded information about antecedents-behaviors-consequences for each episode of elopement between appointments and data were reviewed at subsequent appointments.</p> <p>Appointment two focused on the home elopement safety plan (HESP) aimed at prevention strategies for elopement. The therapist reviewed the baseline HESC (described above). Items marked "no" were written on the HESP along with a plan for addressing the item (see Fig. 1). A few items were designated for homework each week and the therapist updated the HESP at each subsequent appointment. After the HESP, content differed based on the bolting or wandering protocol.</p> <p>Graph: Fig. 1 Example items from a Home Elopement Safety Plan</p> <hd id="AN0151229727-14">Bolting Protocol: Appointments 3–4</hd> <p>The therapist coached the caregiver to implement a trial-based functional analysis (Davis et al. [<reflink idref="bib12" id="ref47">12</reflink>]; Neidert et al. [<reflink idref="bib27" id="ref48">27</reflink>]), implemented where elopement was reportedly most likely (e.g., store, park). Trial length varied (5 to 15 min) based on caregiver report of average latency from exposure to the relevant antecedent to elopement. Conditions were selected based on parent-report, but the assessment for most participants included tangible, attention, escape, and toy play conditions. Each condition was conducted at least 3 times, with more replications if results were unclear. In each condition, the targeted antecedent was implemented at the commencement of the trial and, if elopement occurred, the hypothesized functional reinforcer was delivered for either two minutes or the remainder of the trial, whichever was longer. The control condition included free-access to all hypothesized functional reinforcers (see Neidert et al. [<reflink idref="bib27" id="ref49">27</reflink>] for a more detailed description of similar procedures). The caregiver implemented the functional analysis contingences while the therapist recorded the latency to elopement. The manual included instructions for graphing and data interpretation.</p> <hd id="AN0151229727-15">Bolting Protocol: Appointment 5</hd> <p>The therapist implemented behavioral skills training with the parent for each treatment component. Treatment was based on results of the functional analysis with three components: (a) delivery of the functional reinforcer on a non-resetting differential reinforcement of other behavior (DRO) schedule (interval set at 80% of the average latency to elopement in the functional analysis); (b) preventing access to the functional reinforcer following elopement (i.e., extinction); and (c) noncontingent access to moderately preferred item(s) and/or attention with a response cost contingent on elopement.</p> <hd id="AN0151229727-16">Bolting Protocol: Appointments 6–10</hd> <p>The therapist observed the caregiver implementing treatment with the child and modified strategies as needed. If treatment was going well, the therapist increased the length of the DRO interval, reduced noncontingent access to items, generalized to new settings, and trained additional caregivers. Other modifications included visual aids (e.g., timers, indicators for reinforcer availability), strategies for implementing extinction (e.g., blocking elopement attempts, prompting), and reducing the DRO time. The manual provided instructions on when to implement each supplemental strategy.</p> <p>After each appointment, the caregiver was assigned homework to practice treatment and collect data on the child's behavior. When the DRO interval was short, this was assigned as practice sessions conducted 3–5 times a week. When the DRO interval was long enough to implement feasibly across the day, the therapist instructed the caregiver to implement treatment at all times where elopement historically occurred. At the last appointment, the clinician discussed additional strategies for maintenance and generalization post-discharge.</p> <hd id="AN0151229727-17">Wandering Protocol: Appointment 3–10</hd> <p>The hypothesis inherent in the wandering protocol was that a functional reinforcer responsible for maintaining elopement was unlikely to be reliably identified in a brief assessment. Thus, the therapist identified reinforcers with a structured interview (Reinforcer Assessment for Individuals with Severe Disability; Fisher et al. [<reflink idref="bib15" id="ref50">15</reflink>]) and a multiple stimulus without replacement (MSWO) preference assessment (see DeLeon and Iwata [<reflink idref="bib14" id="ref51">14</reflink>] for details).</p> <p>The therapist then provided behavioral skills training for each treatment component. The treatment included two components: (a) a resetting DRO where the child received the most preferred item from the MSWO if he/she did not elope for a pre-determined amount of time and (b) response blocking and redirection implemented contingent on elopement. After training, the therapist observed the caregiver implement treatment and adapted treatment as necessary. Changes outlined in the manual and homework assigned were similar to the bolting protocol.</p> <hd id="AN0151229727-18">Data Analysis</hd> <p>The primary outcomes, evaluating preliminary efficacy, included the CGI-I and the HESC. Secondary outcomes included the ABC-H, ABC-I, and PSI. All analyses were conducted following the intention to treat principle. Missing items on a measure (e.g., ABC) were scored in congruence with the scoring manual. Analyses were conducted using SAS v. 9.4 or R v. 3.5.1, with statistical significance assessed at the 0.05 level with two-sided tests.</p> <p>For the CGI-I, the percentage of participants rated as responders (i.e., much improved or very much improved) at endpoint were compared across groups using a Chi-square test. Participants who dropped out were rated as non-responders on the CGI-I.</p> <p>Data-analysis of the ABC-H, ABC-I, HESC, and PSI used mixed effects linear models, with the repeated measurement from baseline to endpoint. Appropriate assumptions and model conditions were verified prior to analysis. Cohen's d effect sizes were also calculated by dividing differences in mean change from baseline by the pooled standard deviations at baseline for that measure. All models included baseline measurements as a covariate to adjust for potential differences between treatment and control groups at baseline.</p> <hd id="AN0151229727-19">Results</hd> <p></p> <hd id="AN0151229727-20">Participants</hd> <p>Table 1 summarizes demographic and clinical characteristics of the 24 randomized participants (22 males, 2 females; mean age 6.7; SD = 2.11; range 4 to 10 years).</p> <p>Table 1 Demographic information for participants at baseline</p> <p> <ephtml> <table frame="hsides" rules="groups"><thead><tr><th align="left"><p>Variable</p></th><th align="left"><p>Treatment group (n = 12)</p></th><th align="left"><p>Control group (n = 11)</p></th></tr></thead><tbody><tr><td align="left"><p>Age, Mean (SD)</p></td><td char="(" align="char"><p>6.42 (2.20)</p></td><td char="(" align="char"><p>7.07 (2.06)</p></td></tr><tr><td align="left"><p>Male, No (%)</p></td><td char="(" align="char"><p>12 (100%)</p></td><td char="(" align="char"><p>8 (66.66%)</p></td></tr><tr><td align="left" colspan="3"><p>Race, No (%)</p></td></tr><tr><td align="left"><p> White</p></td><td char="(" align="char"><p>7 (58.33%)</p></td><td char="(" align="char"><p>4 (33.33%)</p></td></tr><tr><td align="left"><p> Black</p></td><td char="(" align="char"><p>4 (33.33%)</p></td><td char="(" align="char"><p>7 (58.33%)</p></td></tr><tr><td align="left"><p> Other</p></td><td char="(" align="char"><p>1 (8.33%)</p></td><td char="(" align="char"><p>1 (8.33%)</p></td></tr><tr><td align="left" colspan="3"><p>ABC<sup>a</sup>, Mean (SD)</p></td></tr><tr><td align="left"><p> Irritability</p></td><td char="(" align="char"><p>12.7 (2.8)</p></td><td char="(" align="char"><p>11.4 (2.4)</p></td></tr><tr><td align="left"><p> Hyperactivity</p></td><td char="(" align="char"><p>24.9 (3.2)</p></td><td char="(" align="char"><p>18.8 (3.5)</p></td></tr><tr><td align="left"><p> Lethargy</p></td><td char="(" align="char"><p>11.1 (7.3)</p></td><td char="(" align="char"><p>8.6 (5.6)</p></td></tr><tr><td align="left"><p> Stereotypic Behavior</p></td><td char="(" align="char"><p>6.7 (4.9)</p></td><td char="(" align="char"><p>5.1 (4.6)</p></td></tr><tr><td align="left"><p> Inappropriate Speech</p></td><td char="(" align="char"><p>4.6 (3.3)</p></td><td char="(" align="char"><p>3.9 (3.6)</p></td></tr><tr><td align="left" colspan="3"><p>Level of ASD<sup>b</sup>, No (%)</p></td></tr><tr><td align="left"><p> High</p></td><td char="(" align="char"><p>11 (91.67%)</p></td><td char="(" align="char"><p>6 (50.00%)</p></td></tr><tr><td align="left"><p> Moderate</p></td><td char="(" align="char"><p>1(8.33%)</p></td><td char="(" align="char"><p>5 (41.67%)</p></td></tr><tr><td align="left"><p> Low</p></td><td char="(" align="char"><p>0 (0%)</p></td><td char="(" align="char"><p>1 (8.33%)</p></td></tr><tr><td align="left"><p> SB 5 ABIQ<sup>c</sup>, Mean (SD)</p></td><td char="(" align="char"><p>57.83 (19.72)</p></td><td char="(" align="char"><p>(24.82)</p></td></tr></tbody></table> </ephtml> </p> <p> <sups>a</sups>Aberrant Behavior Checklist (ABC) <sups>b</sups>Level of Autism Spectrum Disorder determined with the Autism Diagnostic Observation Schedule comparison score (3–4 = low; 5–7 = moderate; 8–10 = high) <sups>c</sups>Stanford Binet 5 Abbreviated IQ (SB 5 ABIQ)</p> <p>In total, 41 potential participants were screened, with 24 participants enrolling in the study. Of the 17 who did not enroll, reasons included not completing the clinical characterization due to cancellations, no-shows, or failing to return calls to schedule (n = 4) and meeting exclusionary criteria (n = 13). Reasons for exclusion included: clinical characterization indicated no ASD diagnosis (n = 3); caregivers expressed they were unable to attend appointments (n = 3); the child was in, or would start, other treatment for elopement during the study (n = 2); caregiver reported other challenging behavior that required treatment (n = 2); caregiver was not interested in research (n = 2); and caregiver reported elopement was no longer a significant concern (n = 1).</p> <hd id="AN0151229727-21">Feasibility</hd> <p>Individuals who did not attend the clinical characterization appointment and parents that were not interested in research counted in the measure of refusal of presumably eligible participants (6 out of 41; 14.63%). The overall rate of attrition was 16.67% (1 of 12 in FBET and 3 of 12 in control). Attendance to FBET was 90.83%; 109 of 120 appointments completed.</p> <p>Complete data on therapist-rated caregiver adherence was available on 86.24% of completed appointments with a mean caregiver adherence of 82.24%. Of the 109 treatment appointments, 26 were directly observed for therapist fidelity, with a mean therapist fidelity to the manual of 92.14%. Finally, the majority of caregivers assigned to treatment completed the TARF-R acceptability measure (83.33%), with mean acceptability of 90.25% (SD = 4.29%). All caregivers reported they would recommend the treatment to other parents of children with ASD.</p> <p>Caregivers completed 84.38% of targeted outcome measures. At baseline, 23 out of 24 HESC and ABC measures were completed (12 FBET; 11 control); 22 PSIs were completed (11 FBET; 11 control). At endpoint, 20 HESCs and ABCs were completed (11 FBET; 9 control); 16 PSIs were completed (8 FBET; 8 control).</p> <hd id="AN0151229727-22">Efficacy</hd> <p>On the CGI-I, 42% of FBET participants were much improved or very much improved compared to 17% for controls (p = 0.37). Caregivers in the FBET reported significant gains on the HESC, with a change from baseline of 47.4 percentage points compared to 2.3 percentage points for the control group (p < 0.001, d = 1.96). For the ABC-Hyperactivity, children in the active treatment demonstrated a 7.5 point improvement compared to 2.1 points in the control group (p < 0.05, d = 0.18). There was no significant difference between the control and treatment group in improvements on the ABC-Irritability subscale or the Parenting Stress Index (see Table 2).</p> <p>Table 2 Mean (standard deviation) efficacy outcomes for treatment and control groups</p> <p> <ephtml> <table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="2"><p>Outcome</p></th><th align="left" colspan="2"><p>Treatment</p></th><th align="left" colspan="2"><p>Control</p></th></tr><tr><th align="left"><p>Pre</p></th><th align="left"><p>Post</p></th><th align="left"><p>Pre</p></th><th align="left"><p>Post</p></th></tr></thead><tbody><tr><td align="left"><p>HESC</p></td><td char="(" align="char"><p>24.2 (18.1)</p></td><td char="(" align="char"><p>71.9 (18.6)</p></td><td char="(" align="char"><p>19.6 (11.3)</p></td><td char="(" align="char"><p>21.9 (10.8)</p></td></tr><tr><td align="left"><p>ABC-I</p></td><td char="(" align="char"><p>12.7 (2.8)</p></td><td char="(" align="char"><p>9.2 (2.8)</p></td><td char="(" align="char"><p>11.4 (2.4)</p></td><td char="(" align="char"><p>12.2 (2.4)</p></td></tr><tr><td align="left"><p>ABC-H</p></td><td char="(" align="char"><p>24.9 (3.2)</p></td><td char="(" align="char"><p>17.4 (3.3)</p></td><td char="(" align="char"><p>18.8 (3.5)</p></td><td char="(" align="char"><p>20.9 (3.6)</p></td></tr><tr><td align="left"><p>PSI-DC</p></td><td char="(" align="char"><p>31.5 (8.0)</p></td><td char="(" align="char"><p>28.3 (7.1)</p></td><td char="(" align="char"><p>31.8 (8.6)</p></td><td char="(" align="char"><p>30.6 (7.6)</p></td></tr><tr><td align="left"><p>PSI-TS</p></td><td char="(" align="char"><p>81.1 (92.2)</p></td><td char="(" align="char"><p>79.3 (17.3)</p></td><td char="(" align="char"><p>87.5 (20.9)</p></td><td char="(" align="char"><p>85.9 (18.7)</p></td></tr></tbody></table> </ephtml> </p> <p> <emph>HESC</emph> Home Elopement Safety Checklist, <emph>ABC</emph>-<emph>I</emph> Aberrant Behavior Checklist—Irritability Subscale, <emph>ABC</emph>-<emph>H</emph> Aberrant Behavior Checklist—Hyperactivity Subscale, <emph>PSI</emph>-<emph>DC</emph> Parenting Stress Index—difficult child subscale, <emph>PSI-TS</emph> Parenting Stress Index—Total Stress.</p> <hd id="AN0151229727-23">Discussion</hd> <p>Our results suggest that the FBET, a manual built on the principles of ABA using a function-based approach in combination with prevention strategies, is acceptable to parents of children with ASD as evidenced by willingness to participate in a randomized trial, low attrition, consistent attendance, adequate caregiver adherence, and high scores on the acceptability measure. The treatment was also reliably delivered by BCBA therapists.</p> <p>Children of caregivers who participated in the FBET showed a significantly greater decrease on the ABC-Hyperactivity subscale compared to the children in the control group. On the HESC, a measure of safety steps in the home, caregivers in the FBET reported more items endorsed as completed at endpoint compared to the control group. There were no statistically significant group differences on the ABC-Irritability, PSI total score, or the rate of positive response on the CGI-I. Given the small sample size, which could only detect large treatment effects, a large-scale study is warranted to more thoroughly test the efficacy of this intervention.</p> <p>To our knowledge, this is the first study of a structured intervention targeting elopement in children with ASD. The assessment and the intervention in the manual rest on a body of evidence from single-case studies (e.g., Boyle and Adamson [<reflink idref="bib8" id="ref52">8</reflink>]; Davis et al. [<reflink idref="bib12" id="ref53">12</reflink>]; Lang et al. [<reflink idref="bib22" id="ref54">22</reflink>]; Neidert et al. [<reflink idref="bib27" id="ref55">27</reflink>]) as well as expert clinical experience (Call et al. [<reflink idref="bib10" id="ref56">10</reflink>]). However, this evidence comes from highly specialized centers and treatment strategies are varied across studies (Boyle and Adamson [<reflink idref="bib8" id="ref57">8</reflink>]; Lang et al. [<reflink idref="bib22" id="ref58">22</reflink>]). Structured treatment programs are more amenable for randomized controlled trials. In addition, development and testing of a structured manual are essential for replication and for eventual dissemination and implementation (Dawson [<reflink idref="bib13" id="ref59">13</reflink>]; Rogers and Vismara [<reflink idref="bib33" id="ref60">33</reflink>]). Feasibility studies are the accepted approach to demonstrate that the intervention is acceptable to the patient population and can be reliably delivered by trained therapists (Smith et al. [<reflink idref="bib36" id="ref61">36</reflink>]). Our results support the feasibility of the FBET.</p> <p>After completion of the study, the experimenters conducted informal debriefings with the therapists. Given the unstructured nature of these interviews, formal qualitative summaries are not possible. However, some suggestions for consideration in future research included adding guidelines for assessment and treatment in different settings (e.g., at parks when it is appropriate for the child to be some distance from a caregiver); inclusion of functional communication training; modifications if extinction is not possible (e.g., the caregiver cannot physically stop the child from accessing the functional reinforcer); and additional handouts for the caregiver.</p> <p>The researchers also evaluated caregiver and therapist errors to guide future manual development. The lowest scored caregiver integrity items were practicing the behavioral intervention and implementing steps from the HESP between appointments (percentage correct = 73.75%). Due to the dichotomous scoring, incorrect could indicate incomplete practice (e.g., the caregiver practiced some, but not as much as decided on in the prior appointment) or incorrect data-collection during practice. A more nuanced measure in future research could help determine the degree of this issue and potential solutions. The second item that received a low integrity score (percentage correct = 72.86%) was the caregivers' ability to describe extinction in the context of negatively reinforced behavior. Future iterations of the manual should include additional detail and clarification on this topic. In regards to therapist integrity, the sample was insufficient to identify trends in incorrect items as fidelity checks were spread across appointments, creating a small sample when evaluating individual items. However, qualitative notes taken by the integrity checker often indicated the therapist ran out of time during appointments with lower integrity scores. It is possible that the manual attempted to cover too much material in each appointment.</p> <p>A more refined measure, including caregiver and therapist integrity on each individual component of treatment scored in real-time while practicing treatment is ideal for future studies. This type of measure was included in the manual, but therapists reported difficulty with coaching the caregiver on treatment strategies, ensuring child safety, collecting data on the child's behavior, and scoring the caregivers' integrity in real-time. Thus, this aspect was removed from data-analysis. Future studies may address this problem through the use of video recordings for retrospective scoring.</p> <p>There are several limitations of this feasibility study to consider. First, outcomes relied on valid parent-rated outcome measures (e.g., Aberrant Behavior Checklist), which are not specific to elopement. Thus, the measures might not capture relevant changes in elopement. Development of a measure specific to elopement is a necessary future research step. Additionally, the researchers developed the HESC for the purpose of this study and the sample size was not sufficient for the analyses necessary to validate this assessment.</p> <p>Future research should also consider using an active control group, with psychoeducation about elopement and prevention strategies. The inclusion of psychoeducation creates a comparison condition that is more representative of what a caregiver might receive in the community from non-behavioral providers.</p> <p>This study lays the groundwork for evaluating a structured behavioral intervention for elopement in children with ASD, which will eventually promote dissemination to providers that may not otherwise have the necessary expertise to conduct this type of assessment and treatment. Elopement is an incredibly dangerous and stressful behavior, making accessibility of treatment of upmost importance. The results of the study support the feasibility of the FBET and sets the stage for a large-scale randomized trial with an active control to evaluate efficacy.</p> <hd id="AN0151229727-24">Author Contributions</hd> <p>MS, NAC, and JLM wrote the treatment manual and contributed to the conceptual design of the intervention and inclusion criteria; MS and NAC oversaw implementation of the clinical trial (including training therapists); LC provided conceptual input on the design of the study and provided oversight on implementation of the clinical trial; CEM oversaw the data-analytic plan, including randomization, data-management, analysis of data, and reporting of outcomes; MS, NAC, JLM, CEM, and LS contributed to writing the manuscript.</p> <hd id="AN0151229727-25">Funding</hd> <p>This study was funded by a grant from the National Institute of Health.</p> <hd id="AN0151229727-26">Publisher's Note</hd> <p>Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.</p> <ref id="AN0151229727-27"> <title> References </title> <blist> <bibl id="bib1" idref="ref40" type="bt">1</bibl> <bibtext> Abidin RR. 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  Data: A Feasibility Randomized Clinical Trial of a Structured Function-Based Intervention for Elopement in Children with Autism Spectrum Disorder
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  Data: <searchLink fieldCode="AR" term="%22Scheithauer%2C+Mindy%22">Scheithauer, Mindy</searchLink> (ORCID <externalLink term="http://orcid.org/0000-0002-0775-1013">0000-0002-0775-1013</externalLink>)<br /><searchLink fieldCode="AR" term="%22Call%2C+Nathan+A%2E%22">Call, Nathan A.</searchLink><br /><searchLink fieldCode="AR" term="%22Lomas+Mevers%2C+Joanna%22">Lomas Mevers, Joanna</searchLink><br /><searchLink fieldCode="AR" term="%22McCracken%2C+Courtney+E%2E%22">McCracken, Courtney E.</searchLink><br /><searchLink fieldCode="AR" term="%22Scahill%2C+Lawrence%22">Scahill, Lawrence</searchLink>
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  Data: <searchLink fieldCode="SO" term="%22Journal+of+Autism+and+Developmental+Disorders%22"><i>Journal of Autism and Developmental Disorders</i></searchLink>. Aug 2021 51(8):2866-2875.
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  Data: Springer. Available from: Springer Nature. One New York Plaza, Suite 4600, New York, NY 10004. Tel: 800-777-4643; Tel: 212-460-1500; Fax: 212-460-1700; e-mail: customerservice@springernature.com; Web site: https://link.springer.com/
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  Data: Y
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  Data: 10
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  Label: Publication Date
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  Data: 2021
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  Data: National Institutes of Health (DHHS)
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  Data: Journal Articles<br />Reports - Research
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  Label: Descriptors
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  Data: <searchLink fieldCode="DE" term="%22Randomized+Controlled+Trials%22">Randomized Controlled Trials</searchLink><br /><searchLink fieldCode="DE" term="%22Intervention%22">Intervention</searchLink><br /><searchLink fieldCode="DE" term="%22Behavior+Problems%22">Behavior Problems</searchLink><br /><searchLink fieldCode="DE" term="%22Children%22">Children</searchLink><br /><searchLink fieldCode="DE" term="%22Autism%22">Autism</searchLink><br /><searchLink fieldCode="DE" term="%22Pervasive+Developmental+Disorders%22">Pervasive Developmental Disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Check+Lists%22">Check Lists</searchLink><br /><searchLink fieldCode="DE" term="%22Behavior+Modification%22">Behavior Modification</searchLink><br /><searchLink fieldCode="DE" term="%22Outcomes+of+Treatment%22">Outcomes of Treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Guides%22">Guides</searchLink>
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  Data: 10.1007/s10803-020-04753-4
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  Label: ISSN
  Group: ISSN
  Data: 0162-3257
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Elopement is a common and dangerous concern in autism spectrum disorder (ASD). There is evidence that behavior analytic treatments can successfully treat elopement, but the research is limited due to small samples and treatment components varying across studies. The current study evaluated the feasibility of studying a manualized intervention for elopement, based on strategies from single-subject research, in a randomized clinical trial with 24 individuals with ASD. Results demonstrated that recruitment was feasible; the manual was acceptable to parents; and therapists followed the manual with high-integrity. Initial efficacy results measured by the Aberrant Behavior Checklist, Clinical Global Impression Scale, and a Home Elopement Safety Checklist suggested improvement in the treatment group that should be studied in future research.
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  Data: 2021
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  Data: EJ1302629
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      – TitleFull: A Feasibility Randomized Clinical Trial of a Structured Function-Based Intervention for Elopement in Children with Autism Spectrum Disorder
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