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Feasibility of Group Parent Training for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot

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Title: Feasibility of Group Parent Training for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot
Language: English
Authors: Burrell, T. Lindsey (ORCID 0000-0003-0682-2614), Postorino, Valentina, Scahill, Lawrence, Rea, Hannah M., Gillespie, Scott, Evans, A. Nichole, Bearss, Karen
Source: Journal of Autism and Developmental Disorders. Nov 2020 50(11):3883-3894.
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: 12
Publication Date: 2020
Document Type: Journal Articles
Reports - Research
Education Level: Adult Education
Descriptors: Intervention, Parent Education, Autism, Pervasive Developmental Disorders, Behavior Problems, Parent Child Relationship, Parent Attitudes, Outcomes of Treatment, Children
DOI: 10.1007/s10803-020-04427-1
ISSN: 0162-3257
Abstract: Delivery of interventions in a group format is a potential solution to limited access to specialized services for children with autism spectrum disorder (ASD). We conducted an open feasibility trial of group-based RUBI parent training in 18 children (mean age 6.12 ± 1.95 years) with ASD and disruptive behaviors. Parents participated in one of five groups (3 to 4 parents per group). Eighty-three percent of participants completed the 24-week trial. Session attendance was moderate (74.2%). All parents indicated that they would recommend the treatment. Therapists demonstrated 98.8% fidelity to the manual. Eleven of 18 (64.7%) participants were rated as much/very much improved by an independent evaluator at Week 24. Preliminary efficacy findings justify further study.
Abstractor: As Provided
Entry Date: 2020
Accession Number: EJ1272159
Database: ERIC
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  Value: <anid>AN0146431865;aut01nov.20;2020Oct16.05:22;v2.2.500</anid> <title id="AN0146431865-1">Feasibility of Group Parent Training for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot </title> <p>Delivery of interventions in a group format is a potential solution to limited access to specialized services for children with autism spectrum disorder (ASD). We conducted an open feasibility trial of group-based RUBI parent training in 18 children (mean age 6.12 ± 1.95 years) with ASD and disruptive behaviors. Parents participated in one of five groups (3 to 4 parents per group). Eighty-three percent of participants completed the 24-week trial. Session attendance was moderate (74.2%). All parents indicated that they would recommend the treatment. Therapists demonstrated 98.8% fidelity to the manual. Eleven of 18 (64.7%) participants were rated as much/very much improved by an independent evaluator at Week 24. Preliminary efficacy findings justify further study.</p> <p>Keywords: Autism spectrum disorder; Group intervention; Parent training; Disruptive behaviors; Feasibility</p> <hd id="AN0146431865-2">Introduction</hd> <p>Twenty-five to 50% of children with Autism Spectrum Disorder (ASD) exhibit behavior problems including tantrums, noncompliance, aggression and self-injury (Hartley et al. [<reflink idref="bib18" id="ref1">18</reflink>]; Hill et al. [<reflink idref="bib20" id="ref2">20</reflink>]; Mazurek et al. [<reflink idref="bib33" id="ref3">33</reflink>]). These behavior problems amplify caregiver stress (Hayes and Watson [<reflink idref="bib19" id="ref4">19</reflink>]; Lecavalier [<reflink idref="bib29" id="ref5">29</reflink>]; Postorino et al. [<reflink idref="bib36" id="ref6">36</reflink>]) and promote uncertainty regarding how to manage these problems (Iadarola et al. [<reflink idref="bib23" id="ref7">23</reflink>]). Serious behavior problems may lead to restrictive school placements (Horner et al. [<reflink idref="bib22" id="ref8">22</reflink>]; Mazefsky et al. [<reflink idref="bib32" id="ref9">32</reflink>]; Mazurek et al. [<reflink idref="bib33" id="ref10">33</reflink>]) as well as social isolation and stigma for parents (Gray [<reflink idref="bib15" id="ref11">15</reflink>]; Waltz [<reflink idref="bib54" id="ref12">54</reflink>]). Furthermore, heightened parenting stress due to serious behavior problems in children may take a toll on parental mental and physical health and undermine family functioning (Mancil et al. [<reflink idref="bib31" id="ref13">31</reflink>]; Tehee et al. [<reflink idref="bib50" id="ref14">50</reflink>]; Postorino et al. [<reflink idref="bib36" id="ref15">36</reflink>]). Heightened parental stress may perpetuate and worsen the child's maladaptive behaviors (Karst and Van Hecke [<reflink idref="bib26" id="ref16">26</reflink>]). Economic impacts include lower household incomes compared to families of children without ASD, due, at least in part, to costs of specialized interventions not covered by insurance and loss of work productivity (Hodgetts et al. [<reflink idref="bib21" id="ref17">21</reflink>]; Lavelle et al. [<reflink idref="bib28" id="ref18">28</reflink>]; Lecavalier [<reflink idref="bib29" id="ref19">29</reflink>]; Neitzel [<reflink idref="bib37" id="ref20">37</reflink>]).</p> <p>The impacts of ASD and disruptive behavior on the child and family warrant intervention. There is growing empirical support for treatments targeting disruptive behaviors in youth with ASD (e.g. Postorino et al. [<reflink idref="bib39" id="ref21">39</reflink>]); however, community demand for these treatments far outpaces availability. Furthermore evidence-based treatments (EBTs) are not always readily adopted in the community (see review in Weisz et al. [<reflink idref="bib61" id="ref22">61</reflink>]). Provider-related factors that limit uptake of EBTs include therapist workload, such as time and number of cases, and limited training opportunities (Weisz et al. [<reflink idref="bib61" id="ref23">61</reflink>]). This lack of access may result in long delays and high costs associated with limited access to expert providers (Lindgren et al. [<reflink idref="bib30" id="ref24">30</reflink>]).</p> <p>One approach to improving access and decreasing therapist workload is group-based delivery of EBTs. Parent training targeting disruptive behavior in young children with ASD is an EBT that is well-positioned for group-based intervention (Bearss et al. [<reflink idref="bib6" id="ref25">6</reflink>]). Group-based Parent Training may also provide social support leading to decreased parental stress and feelings of isolation, and may promote treatment adherence (Ingersoll and Wainer [<reflink idref="bib24" id="ref26">24</reflink>]; Plant and Sanders [<reflink idref="bib38" id="ref27">38</reflink>]; Stahmer and Gist [<reflink idref="bib48" id="ref28">48</reflink>]; Steiner et al. [<reflink idref="bib49" id="ref29">49</reflink>]).</p> <p>Group-based parent training interventions have shown promise for children with disruptive behavior—but without ASD (Webster-Stratton et al. [<reflink idref="bib55" id="ref30">55</reflink>]; Weinberg [<reflink idref="bib59" id="ref31">59</reflink>]). For children with ASD, some group-based interventions have targeted core symptoms (Anan et al. [<reflink idref="bib3" id="ref32">3</reflink>]; Minjarez et al. [<reflink idref="bib34" id="ref33">34</reflink>]; Tonge et al. [<reflink idref="bib51" id="ref34">51</reflink>]). Few group-based parent training interventions have focused on disruptive behaviors in this population (Postorino et al. [<reflink idref="bib39" id="ref35">39</reflink>]).</p> <p>In a multisite randomized trial, the Research Units on Behavioral Intervention (RUBI) network showed that parent training, when delivered individually to parents, was superior to parent education in reducing disruptive behavior and improving daily living skills in young children with ASD (Bearss et al. [<reflink idref="bib6" id="ref36">6</reflink>]; Scahill [<reflink idref="bib44" id="ref37">44</reflink>], [<reflink idref="bib45" id="ref38">45</reflink>]). The RUBI parent training (RUBI-PT) program, which is based on principles of applied behavior analysis (ABA), teaches parents practical strategies to manage the child's disruptive behavior in everyday situations (e.g., getting dressed, getting ready for bed or managing trips to the grocery store). RUBI-PT delivered in a group format has the potential to expand access to services for parents of children with ASD and disruptive behavior.</p> <p>The purpose of the current study is to evaluate the feasibility of RUBI-Group Parent Training (GPT) to determine whether it is acceptable to parents and can be reliably delivered by trained therapists. Parental acceptability was measured by attrition, parental attendance to RUBI-GPT sessions, adherence to the treatment regimen (in session and homework assignments), parent ratings of satisfaction post-treatment and successful collection of outcome data. Therapist reliability was measured by fidelity to the RUBI-GPT manual. In the current study, we established specific benchmarks based on findings from the original RUBI-PT trial (Bearss et al. [<reflink idref="bib6" id="ref39">6</reflink>]) to evaluate the feasibility of the RUBI-PT program when delivered in a group format. The comparison to pre-specified feasibility benchmarks permits an examination of outcomes in a new setting (Weersing [<reflink idref="bib58" id="ref40">58</reflink>]). The secondary aim was to examine the preliminary efficacy of RUBI-GPT to obtain initial signals of improvement in the child's target behaviors. Establishing the feasibility of RUBI-GPT is necessary to justify a large-scale randomized trial.</p> <hd id="AN0146431865-3">Methods</hd> <p></p> <hd id="AN0146431865-4">Design</hd> <p>RUBI-GPT program was delivered over 16 weeks with a follow-up at Week 24 (study endpoint). Our research plan specified five groups with parents of four children per group (N = 20). The intervention was delivered by one of three therapists who were trained to reliability in the RUBI-PT program. Outcome measures, including parent-reported measures and independent clinician ratings, were administered at Baseline, and Weeks 12, 16, and 24. The Emory University Institutional Review Board approved the trial and parents of all participants provided written informed consent at the in-person screen visit prior to collection of study data.</p> <hd id="AN0146431865-5">Participants</hd> <p>Potential participants were contacted for a telephone screen through referral from a clinician at the study treatment center, or outreach to parents of children on the Behavior Clinic wait-list who agreed to be contacted for research opportunities. To be eligible for the study, children between 3 and 8 years of age had: a community diagnosis of ASD that was supported by the Social Communication Questionnaire Lifetime (SCQ); a parental report of mild or greater behavioral problems as measured by the Aberrant Behavior Checklist-Irritability subscale score ≥ 10. In addition, children had to have a receptive language age-equivalent of at least 12 months to ensure comprehension of simple one-step commands; and be in a stable educational or behavioral program with no planned changes for 6 months. Children on stable medications (at least 4 weeks) with no planned changes for 6 months were allowed to participate. Children who did not have an English-speaking parent or a parent who could not travel weekly to the center were excluded. RUBI-GPT was provided at no charge. Families were not paid for their participation in the study.</p> <hd id="AN0146431865-6">Measures</hd> <p></p> <hd id="AN0146431865-7">Feasibility Outcome Measures</hd> <p></p> <hd id="AN0146431865-8">Therapist Treatment Fidelity Checklist (TFC)</hd> <p>This measure, which was used in the randomized trial of RUBI-PT, tracks therapist implementation of session goals for each of the 11 core PT sessions (Bearss et al. [<reflink idref="bib6" id="ref41">6</reflink>]). RUBI core sessions have a range of 6–13 goals per session. Therapists rated themselves on each treatment goal for a session as: 0 = Goal was not achieved; 1 = Goal was partially achieved; 2 = Goal was fully achieved. Treatment fidelity scores for each session are expressed as percentage by computing the sum of points scored for all session goals divided by the total possible points × 100.</p> <hd id="AN0146431865-9">Parent In-Session Adherence Checklist (PAC)</hd> <p>For each of the 11 core RUBI-GPT sessions, therapists also assessed the appropriateness of parental responses to in-session queries (e.g., correct identification of implementation errors in the video vignettes) and accuracy in completion of session activity worksheets. Parental responses for each query were rated on a three-point scale: 0 = Parent did not demonstrate skill or understanding/did not complete assignment(s); 1 = Parent understood or responded correctly to a few of the queries/partially completed assignment(s); 2 = Parent understood and responded correctly to nearly all queries/fully completed assignment(s). RUBI-GPT core sessions have a range of 3–5 parent queries per session. The parent adherence scores for each session are expressed as percentage by computing the sum of points earned for all queries for the session divided by the total possible points × 100.</p> <hd id="AN0146431865-10">Homework Completion</hd> <p>The homework completion scale assessed parent implementation of the homework assignment from each prior session. Parent homework completion (implementation) was rated on a three-point scale: 3 = Intervention implemented consistently and effectively; 2 = Intervention mostly implemented; 1 = Intervention partially implemented; 0 = Few or no interventions implemented. Homework was rated by the therapist following each session and a total mean score was calculated across all sessions.</p> <p>Therapists filled out the TFC, PAC, and Homework Completion forms at the end of each session. To assess therapist fidelity to the manual, parent in-session adherence to treatment, and parent homework completion, all sessions were recorded on video. An independent observer completed therapist TFC in a sample of 20% randomly selected sessions.</p> <hd id="AN0146431865-11">Therapist Impressions of Parental Engagement (TIPE)</hd> <p>The TIPE is a global clinician rating of the parent's overall level of participation and engagement in each treatment session. Ratings of engagement ranged from 0 to 3. Each rating corresponds with a behavior description including: 0 = "Parent does not learn or "buy in" to concepts"; 1 = "Parent struggles during much of the session"; 2 = "Parent is engaged and successful during the majority of the session"; or 3 = "Parent participates actively and positively throughout the session." Each brief descriptor also corresponds with a more detailed example of behaviors that would fit in each category. For example, a score of 0, which suggests that the parent does not understand or agree with concepts taught in session, may be represented by falling asleep in session, or refusing to answer questions or participate in group activities. If more than one caregiver attended the session, each caregiver received a TIPE rating. Therapists filled out the TIPE for each parent at the end of each session.</p> <hd id="AN0146431865-12">Parent Satisfaction Questionnaire (Research Unit on Pediatric Psychopharmacology; RUPP Autism...</hd> <p>This 20-item questionnaire was developed by the RUPP Autism Network (Aman et al. [<reflink idref="bib1" id="ref42">1</reflink>]). At the end of the RUBI-GPT program, each parent rated the quality of the program on the number and length of sessions, the usefulness of teaching tools (e.g., worksheets and homework), the value of program elements, and their confidence in handling future behavioral problems. Items were scored on a 3- or 4-point Likert scale, with higher scores reflecting greater levels of satisfaction.</p> <hd id="AN0146431865-13">Efficacy Outcome Measures</hd> <p></p> <hd id="AN0146431865-14">Aberrant Behavior Checklist (ABC; Aman and Singh 2017)</hd> <p>The ABC is a reliable and valid 58-item, parent-report that includes five subscales: <emph>Irritability</emph> (tantrums, aggression and self-injurious behaviors, 15 items); <emph>Social Withdrawal</emph> (16 items); <emph>Stereotypies</emph> (7 items); <emph>Hyperactivity</emph> (16 items); and <emph>Inappropriate Speech</emph> (4 items). Each item is rated on a 0 to 3 scale with higher scores indicating greater severity. Internal consistency for the five ABC subscales ranges from 0.72 to 0.89. The ABC also has normative data in children with ASD (Kaat et al. [<reflink idref="bib25" id="ref43">25</reflink>]). The primary outcome measure for this pilot study was the ABC Irritability subscale (ABC-I). This subscale has been used as an outcome measure in several clinical trials (Aman et al. [<reflink idref="bib1" id="ref44">1</reflink>]; Bearss et al. [<reflink idref="bib6" id="ref45">6</reflink>]). The report by Kaat et al. ([<reflink idref="bib25" id="ref46">25</reflink>]) provides data a sample of 1893 children with ASD (ages 2 to 18 years) ascertained from the Autism Treatment Network. The mean score on the ABC-I for this age group was approximately 13 ± 9. Thus, scores ≥ 22 reflect clinical concern on this dimension. The other ABC subscales were included as exploratory outcomes.</p> <hd id="AN0146431865-15">Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD; Chowdhury et al. 2016)</hd> <p>The HSQ-ASD is a 24-item parent rating of child noncompliance in everyday situations (Chowdhury et al. [<reflink idref="bib10" id="ref47">10</reflink>]). The measure contains two 12-item subscales (Demand-Specific; Socially Inflexible). Parents are asked whether or not the child was noncompliant in a given situation in the past 4 weeks. "Yes" items are then scored on a 1 to 9 scale, with higher scores indicating greater noncompliance. The sum of the severity scores on the "yes" items is divided by 24 to obtain a per item mean. Internal consistency is high for the two HSQ-ASD subscales (0.84–0.89 (Chowdhury et al. [<reflink idref="bib10" id="ref48">10</reflink>]). This version of the HSQ-ASD was used in the randomized RUBI-PT trial (Bearss et al. [<reflink idref="bib6" id="ref49">6</reflink>]). In that study, the mean score at baseline was 3.9 ± 1.5.</p> <hd id="AN0146431865-16">Parent Target Problems (PTP; Arnold et al. 2003; Scahill 2016a, b)</hd> <p>At Baseline, the Independent Evaluator (IE) asked the primary caregiver to describe the child's two most pressing problems. To characterize these problems, the IE inquired about the frequency (for episodic behaviors) or constancy (for problems such as hyperactivity that reflect more enduring behavior patterns), as well as the impact of the behavior on the family. Based on this discussion, the PTPs were documented in a brief narrative. The Baseline narrative was reviewed and revised at Weeks 12, 16 and 24 to capture a description of the child's current behavior. The same problem label was used at each time point.</p> <p>Examples of target problems:</p> <hd id="AN0146431865-17">Boy Age 6: Angry Outbursts, Baseline</hd> <p>Child engages in screaming and crying and sometimes hitting or kicking—if father is present. These behaviors occur two to four times each day and last 15 to 20 min. Higher intensity episodes including yelling, throwing objects, destroying property, hitting, and kicking, occur one to two times per week and last 20 to 40 min. Household is in constant turmoil.</p> <hd id="AN0146431865-18">Angry Outbursts, Week 24</hd> <p>Angry outbursts including screaming, crying, and rarely hitting, occur two to four times per week. Behaviors last between 15 and 20 min when they occur. More intense behaviors occur once monthly and may include yelling, throwing objects, and destroying property. He will occasionally hit is sister in a high intensity outburst. The household is no longer in constant upheaval.</p> <hd id="AN0146431865-19">Girl Age 4 Tantrums, Baseline</hd> <p>Tantrums occur one to four times daily when demands are placed. Tantrums include yelling, screaming, throwing objects, hitting herself, and throwing self on the floor. Behaviors last five to 10 min and often occur in public. Due to common occurrence of tantrums in public, parent avoids taking child to public places.</p> <hd id="AN0146431865-20">Tantrums, Week 24</hd> <p>Tantrums occur between one to three times each day and consist of yelling, screaming, stomping her feet, hitting herself, or throwing self to ground. Each tantrum lasts 2 to 3 min. Caregiver takes child to public places; tantrums still occur sometimes in public places.</p> <hd id="AN0146431865-21">Parent Target Problems Ratings</hd> <p>Following study completion of the study, the PTPs were reviewed and classified by behavioral topography (see Table 1). To reduce the number of categories, some behavioral topographies were collapsed into a single category. For example, tantrums that included aggression were collapsed into tantrums, if the aggression only occurred in the context of the tantrum (e.g. screaming, crying, and dropping to the floor). Behaviors described as not following rules or verbal instruction was collapsed into Noncompliance. The resulting categories included: (<reflink idref="bib1" id="ref50">1</reflink>) Tantrums, (<reflink idref="bib2" id="ref51">2</reflink>) Social and communication concerns, (<reflink idref="bib3" id="ref52">3</reflink>) Noncompliance, (<reflink idref="bib4" id="ref53">4</reflink>) Dangerous/impulsive behavior, (<reflink idref="bib5" id="ref54">5</reflink>) Behavioral rigidity, (<reflink idref="bib6" id="ref55">6</reflink>) Aggression, (<reflink idref="bib7" id="ref56">7</reflink>) Verbally demanding behavior, (<reflink idref="bib8" id="ref57">8</reflink>) Repetitive behavior, and (<reflink idref="bib9" id="ref58">9</reflink>) Anxiety.</p> <p>Parent target problem ratings</p> <p> <ephtml> <table frame="hsides" rules="groups"><thead><tr><th align="left"><p>Behavior N = 18 (%)</p></th><th align="left" /></tr></thead><tbody><tr><td align="left"><p>Tantrums</p></td><td char="(" align="char"><p>11 (61.11%)</p></td></tr><tr><td align="left"><p>Social and communication concerns</p></td><td char="(" align="char"><p>7 (38.89%)</p></td></tr><tr><td align="left"><p>Noncompliance</p></td><td char="(" align="char"><p>6 (33.33%)</p></td></tr><tr><td align="left"><p>Dangerous/impulsive behavior</p></td><td char="(" align="char"><p>3 (16.67%)</p></td></tr><tr><td align="left"><p>Behavioral rigidity</p></td><td char="(" align="char"><p>3 (16.67%)</p></td></tr><tr><td align="left"><p>Aggression</p></td><td char="(" align="char"><p>2 (11.11%)</p></td></tr><tr><td align="left"><p>Verbally demanding behavior</p></td><td char="(" align="char"><p>2 (11.11%)</p></td></tr><tr><td align="left"><p>Repetitive behavior</p></td><td char="(" align="char"><p>1 (5.56%)</p></td></tr><tr><td align="left"><p>Anxiety</p></td><td char="(" align="char"><p>1 (5.56%)</p></td></tr></tbody></table> </ephtml> </p> <hd id="AN0146431865-22">Clinical Global Impression: Improvement Scale (CGI-I; Guy 1976)</hd> <p>The CGI-I is a 7-point scale that was completed by the independent evaluator (IE) at Weeks 12, 16 and 24 to rate overall change from Baseline. Scores range from 1 (Very Much Improved) through 4 (Unchanged) to 7 (Very Much Worse). The IE, who was not involved in the delivery of group RUBI-PT, used all available information for each child (e.g., the ABC, HSQ-ASD, PTP) to score the CGI-I. The interpretation of change on the ABC-I and HSQ-ASD was based on reports by Kaat, Lecavalier and Aman ([<reflink idref="bib25" id="ref59">25</reflink>]) and Bearss et al. ([<reflink idref="bib6" id="ref60">6</reflink>]). Positive response was defined as a CGI-I score of 1 (Very Much Improved) or 2 (Much Improved) at Week 24. Participants with missing data at Week 24 were classified as having a negative treatment response.</p> <hd id="AN0146431865-23">The Vineland Adaptive Behavior Scales, Second Edition, Parent/Caregiver Form (Sparrow et al....</hd> <p>This version of the Vineland is completed by the primary caregiver to measure the child's adaptive behavior across three domains: Socialization, Communication, and Daily Living Skills (Sparrow et al. [<reflink idref="bib47" id="ref61">47</reflink>]). The Vineland-II asks parents to rate what the child actually "does" (versus what the child is able to do) in the course of daily living using the following scale: 0 = child is unable to perform the skill; 1 = child performs the skill sometimes or 2 = child regularly performs the skill. The Vineland-II domains have been standardized (mean of 100 ± 15). Internal consistency across domains ranges from 0.83 to 0.90, with test–retest reliability ranging from 0.78 to 0.92 (Sparrow et al. [<reflink idref="bib47" id="ref62">47</reflink>]). Results from a previous randomized trial of RUBI-PT showed that improvements in disruptive behavior were accompanied by improvements in the Vineland Daily Living Domain (Scahill [<reflink idref="bib44" id="ref63">44</reflink>], [<reflink idref="bib45" id="ref64">45</reflink>]).</p> <hd id="AN0146431865-24">RUBI-GPT Intervention</hd> <p>The RUBI-GPT program was derived from the one-to-one RUBI-PT program (Bearss et al. [<reflink idref="bib5" id="ref65">5</reflink>], [<reflink idref="bib7" id="ref66">7</reflink>]). Three RUBI-PT certified therapists with experience in parent training and ASD intervention conducted group sessions. Certification involves completion of 2 training cases with ≥ 80% treatment fidelity and direct supervision and feedback from a RUBI-PT treatment developer. RUBI-GPT involved 10 core sessions, 1 individual parent–child coaching session and 1 supplemental session (e.g., feeding, toileting, sleep) delivered over the course of 16 weeks. Each session lasted approximately 120 min. During the 16 weeks, parents had the opportunity to participate in up to two, 30-min individual sessions to make up a missed group session. A telephone booster session at Week 20 focused on generalization and maintenance of skills.</p> <p>The RUBI-GPT program was designed to address a wide range of disruptive behavior and skill deficits in children with ASD. As with the individually-delivered RUBI-PT program, the foundation of RUBI-GPT is the Antecedent-Behavior-Consequence (ABC) model. The ABC model identifies the antecedent (situations or events that precede disruptive behavior) and the consequence (parental or environmental response that may reinforce the behavior) of target behaviors. Analysis of these elements is used to determine the purpose or "function" of the child's behavior. Core sessions focus on teaching the ABC model to parents, presenting techniques for antecedent management, as well as strategies to implement appropriate consequences including positive reinforcement, planned ignoring, and compliance training. These sessions are followed by teaching techniques such as task analysis and chaining to improve the child's adaptive behaviors (e.g., brushing teeth, hand washing, dressing, tying shoes, manipulating buttons and zippers). Finally, parents are taught strategies to maintain and generalize the child's treatment gains to other environments, people, and stimuli. The organizing principle is that decreasing maladaptive behaviors through the use of the ABC model sets the stage for acquisition of new skills and regular performance of everyday living skills (Scahill [<reflink idref="bib44" id="ref67">44</reflink>], [<reflink idref="bib45" id="ref68">45</reflink>]). Supplemental sessions, such as toileting, feeding, and sleep, were offered according to child-specific needs. The RUBI-GPT manual includes detailed therapist scripts to promote treatment fidelity. Treatment sessions employ direct instruction, practice activities, and behavior rehearsal with feedback to foster parental skill acquisition. In addition, parents are presented with brief video vignettes to illustrate effective and ineffective responses to the child's behavior. Some vignettes also provide a test of parental knowledge of materials covered in the session. Weekly homework assignments encouraged parents to apply the new techniques to manage behavior.</p> <p>The transition from the original RUBI-PT protocol to a group format required careful consideration. The primary consideration involved the appropriate size of the group. A core component of RUBI is to review homework from the prior week as well as time at the end of session to design upcoming homework assignments to the child-specific needs. To maintain this personalized approach to reviewing and designing homework we limited the group size to caregivers of 4 children (other caregivers could also attend).</p> <p>Content modifications were also made (see Table 2 for a comparison of RUBI-PT and RUBI-GPT by session). For example, the two home visits were replaced with a group session focused on the home environment ("Controlling the Home Environment") that also included materials from Session 2 (Prevention Strategies). The original "Prevention Strategies" session was divided into two sessions due to the density of this content. By contrast, the "Planned Ignoring," was combined with "Functional Communication Skills;" "Reinforcement I" and "Reinforcement II" sessions were also combined.</p> <p>Group parent training session comparison to RUBI trial (Bearss et al. [<reflink idref="bib6" id="ref69">6</reflink>])</p> <p> <ephtml> <table frame="hsides" rules="groups"><thead><tr><th align="left"><p>Sessions</p></th><th align="left"><p>RUBI-PT</p></th><th align="left"><p>RUBI-GPT</p></th></tr></thead><tbody><tr><td align="left"><p>1</p></td><td align="left"><p>Behavioral principles</p></td><td align="left"><p>Orientation and baseline assessment</p></td></tr><tr><td align="left"><p>2</p></td><td align="left"><p>Prevention strategies</p></td><td align="left"><p>Behavioral principles</p></td></tr><tr><td align="left"><p>3</p></td><td align="left"><p>Daily schedules<sup>a</sup></p></td><td align="left"><p>Prevention strategies</p></td></tr><tr><td align="left"><p>4</p></td><td align="left"><p>Reinforcement I</p></td><td align="left"><p>Daily schedules</p></td></tr><tr><td align="left"><p>5</p></td><td align="left"><p>Reinforcement II</p></td><td align="left"><p>Home environment</p></td></tr><tr><td align="left"><p>6</p></td><td align="left"><p>Planned ignoring</p></td><td align="left"><p>Reinforcement I & II</p></td></tr><tr><td align="left"><p>7</p></td><td align="left"><p>Compliance training</p></td><td align="left"><p>Planned ignoring & FCT</p></td></tr><tr><td align="left"><p>8</p></td><td align="left"><p>FCT</p></td><td align="left"><p>Compliance training</p></td></tr><tr><td align="left"><p>9</p></td><td align="left"><p>Teaching skills I</p></td><td align="left"><p>Teaching skills I & II</p></td></tr><tr><td align="left"><p>10</p></td><td align="left"><p>Teaching skills II</p></td><td align="left"><p>Parent–child coaching</p></td></tr><tr><td align="left"><p>11</p></td><td align="left"><p>Generalization & maintenance</p></td><td align="left"><p>Generalization & maintenance</p></td></tr><tr><td align="left"><p>Optional sessions</p></td><td align="left"><p>Choice of 2</p></td><td align="left"><p>Choice of 1</p></td></tr></tbody></table> </ephtml> </p> <p> <sups>a</sups>Home visit in RUBI-PT was conducted after Daily Schedules (i.e., after session 3)</p> <hd id="AN0146431865-25">Analytic Plan</hd> <p></p> <hd id="AN0146431865-26">Feasibility</hd> <p>We examined attrition, session attendance (actual number of sessions attended divided by the expected number of sessions, multiplied by 100), parental adherence to session objectives, and satisfaction with delivery of the RUBI-GPT intervention. We also calculated therapist fidelity to the manual. Based on our prior study (Bearss et al. [<reflink idref="bib6" id="ref70">6</reflink>]), we set the following benchmarks: attrition ≤ 11%, attendance to core sessions≥ 90%, parental adherence ≥ 95%, and ≥ 97% for therapist fidelity.</p> <hd id="AN0146431865-27">Preliminary Efficacy</hd> <p>Statistical significance was evaluated at the 0.05 level, and data analyses were performed using SAS v9.4 (Cary, NC) ([<reflink idref="bib43" id="ref71">43</reflink>]). Quantitative summaries for child, parent, and household characteristics were calculated for the full sample using means and standard deviations for continuous variables and frequencies and percentages for categorical measures. Mixed effects linear regression, using all available data, was employed to evaluate least squares (LS) mean changes in study end points from Baseline to Weeks 12, 16 and 24 for the ABC, HSQ-ASD, and from Baseline to Week 24 for the Vineland measures. At each end point, the LS mean difference in measurement outcomes was estimated together with two-sided 95% confidence intervals (CI). The regression models for each measure included fixed effects for study visit (4 or 2 levels, based on measure). Random effects were the subject-specific intercepts. Model covariance structures were modeled separately for each round of participants (5 total), and degrees of freedom were estimated using the Kenward-Roger procedure. Residual errors were confirmed for normality in each case via histograms, boxplots, and quantile–quantile probability plots. Concurrent with the mixed model framework, missing data were assumed to be at random. Effect sizes (ES) were calculated across the different outcomes by dividing the absolute LS mean difference from Baseline by the pooled standard deviation at Baseline. ES were considered as small (0.2), medium (0.5), or large (0.8). On the CGI-I at Weeks 16 and 24, we calculated the percentage of participants showing a positive response.</p> <hd id="AN0146431865-28">Results</hd> <p></p> <hd id="AN0146431865-29">Participants</hd> <p>Participants were enrolled in the study over 2 years. Thirty-three children were screened for eligibility by telephone. Six children were ineligible for various reasons (e.g., age, did not have ASD). Based on the telephone screen, 27 children appeared eligible. Parents of 8 children declined to proceed due to distance from clinic, scheduling problems, or initiation of behavioral services in the community. The clinical evaluation was conducted by an experienced team. The assessment included a parent-completed demographic form that included child's sex, age, ethnicity, and school placement, as well as parent age, education, family living arrangement, and income. Parents also completed the 40-item Social Communication Questionnaire Lifetime (SCQ; Rutter et al. [<reflink idref="bib42" id="ref72">42</reflink>]). The SCQ is designed to assist with the diagnosis of ASD in individuals over the age of 4 years, with a mental age of at least 2 years. Internal consistency of the SCQ ranges from 0.84 to 0.93 across age groups (Corsello et al. [<reflink idref="bib12" id="ref73">12</reflink>]). The first item, which is not included in the scoring, asks whether the individual is verbal or non-verbal. If the child is non-verbal, the six language items are skipped. The total possible score is 0–33 for nonverbal children and 0–39 for verbal children. A total score > 15 is highly predictive of ASD (Corsello et al. [<reflink idref="bib12" id="ref74">12</reflink>]).</p> <p>The assessment also included cognitive testing according to the child's age and language abilities. Ten of 18 children completed the <emph>Stanford</emph>-<emph>Binet Intelligence Scales</emph>-<emph>Fifth Edition</emph> (SB-5; Roid [<reflink idref="bib41" id="ref75">41</reflink>]), four children completed the <emph>Differential Ability Scales</emph>-<emph>Second Edition</emph> (DAS-II; Elliott [<reflink idref="bib14" id="ref76">14</reflink>]), one child completed the <emph>Wechsler Preschool and Primary Scales</emph>—<emph>3rd Edition</emph> (WPPSI-III; Wechsler [<reflink idref="bib56" id="ref77">56</reflink>]), and one child completed the <emph>Wechsler Intelligence Scale for Children, Fourth Edition</emph> (WISC-IV; Wechsler [<reflink idref="bib57" id="ref78">57</reflink>]). Two children completed the <emph>Mullen Scales of Early Learning</emph> (Mullen [<reflink idref="bib35" id="ref79">35</reflink>]).</p> <p>Nineteen children completed the in-person screening visit. Of these, 18 participants (mean age = 6.12 ± 1.95 years; 12 boys and 6 girls) met eligibility criteria to participate. Caregivers of these 18 children participated in one of five groups (three groups of four and two groups of three parents). Table 3 presents demographic and clinical data of the study participants. The sample included 66.7% African American children and just over half the families reported annual household income of less than $40,000. Fifty-three percent of children had an IQ < 70 and a mean score of 69 on Vineland Communication at Baseline. All participants had a community diagnosis of ASD and all scored above the SCQ cut-off, supporting the diagnosis of ASD. Parents nominated tantrums in 11 of 18 (61.11%) children, social and communication concerns in 38.89%, noncompliance in 33.33%, dangerous/impulsive behavior in 16.67%, behavioral rigidity in 16.67%, aggression in 11.11%, verbally demanding behavior in 11.11%, repetitive behavior in 5.56%, and anxiety in 5.56%.</p> <p>Baseline demographic and clinical characteristics (N = 18)</p> <p> <ephtml> <table frame="hsides" rules="groups"><thead><tr><th align="left"><p>Characteristics</p></th><th align="left" /></tr></thead><tbody><tr><td align="left"><p>Child demographics</p></td><td align="left" /></tr><tr><td align="left"><p>Child age, mean ± SD</p></td><td align="left"><p>6.12 ± 1.95</p></td></tr><tr><td align="left"><p>Gender: males, N (%)</p></td><td align="left"><p>12 (66.7%)</p></td></tr><tr><td align="left"><p>Race, N (%)</p></td><td align="left" /></tr><tr><td align="left"><p> White, non-hispanic</p></td><td align="left"><p>4 (22.2%)</p></td></tr><tr><td align="left"><p> African American, Non-Hispanic</p></td><td align="left"><p>12 (66.7%)</p></td></tr><tr><td align="left"><p> Other (Asian, mixed race)</p></td><td align="left"><p>2 (11.1%)</p></td></tr><tr><td align="left"><p>Ethnicity: Hispanic</p></td><td align="left"><p>1 (5.9%)</p></td></tr><tr><td align="left"><p>School program, N (%)</p></td><td align="left" /></tr><tr><td align="left"><p> Regular school (public and private)</p></td><td align="left"><p>9 (50%)</p></td></tr><tr><td align="left"><p> Special education</p></td><td align="left"><p>8 (44.4%)</p></td></tr><tr><td align="left"><p> Home school</p></td><td align="left"><p>1 (5.6%)</p></td></tr><tr><td align="left"><p>Caregiver demographics</p></td><td align="left" /></tr><tr><td align="left"><p> Maternal age, mean ± SD</p></td><td align="left"><p>37 ± 6.74</p></td></tr><tr><td align="left"><p> Maternal race, N (%)</p></td><td align="left"><p>N (%)</p></td></tr><tr><td align="left"><p> White, Non-Hispanic</p></td><td align="left"><p>4 (22.2%)</p></td></tr><tr><td align="left"><p> African American, Non-Hispanic</p></td><td align="left"><p>12 (66.7%)</p></td></tr><tr><td align="left"><p> Other (Asian, mixed race)</p></td><td align="left"><p>2 (11.1%)</p></td></tr><tr><td align="left"><p> Maternal ethnicity: Hispanic</p></td><td align="left"><p>0 (0%)</p></td></tr><tr><td align="left"><p>Maternal employment</p></td><td align="left" /></tr><tr><td align="left"><p> Disabled</p></td><td align="left"><p>1 (5.6%)</p></td></tr><tr><td align="left"><p> Full-time</p></td><td align="left"><p>4 (22.2%)</p></td></tr><tr><td align="left"><p> Housekeeper</p></td><td align="left"><p>4 (22.2%)</p></td></tr><tr><td align="left"><p> Part-time</p></td><td align="left"><p>5 (27.8%)</p></td></tr><tr><td align="left"><p> Student</p></td><td align="left"><p>1 (5.6%)</p></td></tr><tr><td align="left"><p> Unemployed</p></td><td align="left"><p>3 (16.7%)</p></td></tr><tr><td align="left"><p>Maternal education, N (%)</p></td><td align="left" /></tr><tr><td align="left"><p> College or more</p></td><td align="left"><p>8 (44.4%)</p></td></tr><tr><td align="left"><p> Less than college</p></td><td align="left"><p>10 (55.6%)</p></td></tr><tr><td align="left"><p>Father age, mean ± SD (N = 13)</p></td><td align="left"><p>39.27 ± 7.36</p></td></tr><tr><td align="left"><p>Father race</p></td><td align="left" /></tr><tr><td align="left"><p> White, non-Hispanic</p></td><td align="left"><p>5 (27.8%)</p></td></tr><tr><td align="left"><p> African American, Non-Hispanic</p></td><td align="left"><p>12 (66.7%)</p></td></tr><tr><td align="left"><p> Other (Asian, mixed race)</p></td><td align="left"><p>1 (5.6%)</p></td></tr><tr><td align="left"><p> Father ethnicity: Hispanic</p></td><td align="left"><p>1 (5.9%)</p></td></tr><tr><td align="left"><p>Father employment</p></td><td align="left" /></tr><tr><td align="left"><p> Full time</p></td><td align="left"><p>12 (85.7%)</p></td></tr><tr><td align="left"><p> Part time</p></td><td align="left"><p>2 (14.3%)</p></td></tr><tr><td align="left"><p>Father education</p></td><td align="left" /></tr><tr><td align="left"><p> College or more</p></td><td align="left"><p>8 (53.3%)</p></td></tr><tr><td align="left"><p> Less than college</p></td><td align="left"><p>7 (46.7%)</p></td></tr><tr><td align="left"><p>Household income, N (%)</p></td><td align="left" /></tr><tr><td align="left"><p> < $40,000</p></td><td align="left"><p>9 (56.3%)</p></td></tr><tr><td align="left"><p> $40,000–$80,000</p></td><td align="left"><p>4 (25%)</p></td></tr><tr><td align="left"><p> > $80,000</p></td><td align="left"><p>3 (18.7%)</p></td></tr><tr><td align="left"><p>On federal assistance</p></td><td align="left"><p>11 (61.1%)</p></td></tr><tr><td align="left"><p>More than one child in the home</p></td><td align="left"><p>14 (77.8%)</p></td></tr><tr><td align="left"><p>Other ASD children in home</p></td><td align="left"><p>2 (14.2%)</p></td></tr><tr><td align="left"><p>Two-parent household (including step-parents)</p></td><td align="left"><p>10 (55.6%)</p></td></tr><tr><td align="left"><p>Partner involvement</p></td><td align="left" /></tr><tr><td align="left"><p> Not at all</p></td><td align="left"><p>2 (11.8%)</p></td></tr><tr><td align="left"><p> Somewhat</p></td><td align="left"><p>6 (35.3%)</p></td></tr><tr><td align="left"><p> Very</p></td><td align="left"><p>4 (23.5%)</p></td></tr><tr><td align="left"><p> Extremely</p></td><td align="left"><p>5 (29.4%)</p></td></tr><tr><td align="left"><p>Child clinical characteristics</p></td><td align="left" /></tr><tr><td align="left"><p> SCQ total score</p></td><td align="left"><p>21.06 ± 4.29</p></td></tr><tr><td align="left"><p>CGI severity, N (%)</p></td><td align="left" /></tr><tr><td align="left"><p> Moderately Ill</p></td><td align="left"><p>9 (64.3%)</p></td></tr><tr><td align="left"><p> Markedly Ill</p></td><td align="left"><p>5 (35.7%)</p></td></tr></tbody></table> </ephtml> </p> <hd id="AN0146431865-30">Feasibility Outcomes</hd> <p>The average time from screening to Baseline was 11 ± 12 days. Baseline assessments were completed at the first group session to ensure that severity measures were current. Table 4 compares RUBI-GPT feasibility outcomes to the pre-specified feasibility benchmarks. Three children (16.7%) dropped-out of treatment: two exited the trial prior to Week 16 and one exited the trial between Week 16 and Week 24. Reasons for drop-out included transportation difficulties, scheduling conflicts, and other family related circumstances (e.g. death in the family, caregiving requirements for an aging parent). Of the 198 expected core sessions (10 core sessions and 1 parent-coaching session × 18 participants), actual attendance was 147 (74.2%). Fourteen of 18 parents completed the <emph>Parent Satisfaction Questionnaire</emph>. Eighty-six percent (12 out of 14) reported that the number of sessions was appropriate and all participants found that the group format was <emph>somewhat</emph> to <emph>very helpful</emph>. All caregivers reported greater confidence in managing current and future disruptive behaviors and reportedly were implementing behavioral strategies to address child disruptive behaviors at home. All caregivers also indicated that they would recommend the program to other parents of children ASD and with similar problems.</p> <p>Feasibility benchmarks based on the RUBI trial (Bearss et al. [<reflink idref="bib6" id="ref80">6</reflink>])</p> <p> <ephtml> <table frame="hsides" rules="groups"><thead><tr><th align="left"><p>Outcome</p></th><th align="left"><p>Benchmark</p></th><th align="left"><p>Outcome</p></th></tr></thead><tbody><tr><td align="left"><p>Parent acceptability</p></td><td align="left" /><td align="left" /></tr><tr><td align="left"><p> Attrition</p></td><td align="left"><p>11.2%</p></td><td align="left"><p>16.7% (3/18)</p></td></tr><tr><td align="left"><p> Core session attendance</p></td><td align="left"><p>92%</p></td><td align="left"><p>74.2% (147/198)</p></td></tr><tr><td align="left"><p> Adherence</p></td><td align="left"><p>94.7%</p></td><td align="left"><p>91.7%</p></td></tr><tr><td align="left"><p> Satisfaction</p></td><td align="left"><p>95% recommend</p></td><td align="left"><p>100% recommend</p></td></tr><tr><td align="left"><p>Therapist fidelity</p></td><td align="left"><p>96.7%</p></td><td align="left"><p>98.8%</p></td></tr><tr><td align="left"><p>Outcome data collection</p></td><td align="left"><p>90%</p></td><td align="left"><p>77.8% at week 24</p></td></tr></tbody></table> </ephtml> </p> <p>Independent review of the 20% randomly selected video recordings by a RUBI-GPT trained therapist who was not involved in delivery. Therapist showed excellent fidelity to the manual (mean: 98.8%, SD: 2.7%). Parent in-session adherence to treatment was moderate with notable variability (mean % adherence = 78.1%, SD = 20.5%, range 20–97.33%). The mean parental engagement score indicated that parents were "mostly engaged" during the sessions (mean = 2.2 out of 3, SD = 0.6; range 0.3–2.9). Parent homework completion was variable (mean = 1.5 of 3; SD: 0.6; range 0.125 to 2.25).</p> <hd id="AN0146431865-31">Efficacy Outcomes</hd> <p>From Baseline to Week 24, there were statistically significant improvements on the parent-rated ABC-I and HSQ-ASD with effect sizes of 0.87 and 0.48, respectively (Table 5). Figures 1 and 2 show the steady reduction in the ABC-I and HSQ-ASD over time. The Social Withdrawal, Hyperactivity, Stereotypy, and Inappropriate Speech subscales of the ABC also showed significant improvements from Baseline to Week 24 (see Table 5). At Week 24, Vineland Standard Scores showed no significant change from Baseline. On the CGI-I, the independent evaluator rated eight of 18 (44.4%) and 11 of 18 participants (61.1%) as much improved or very much improved by at Weeks 16 and 24, respectively.</p> <p>Change in measure scores from Baseline to Week 24</p> <p> <ephtml> <table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="2"><p>Domain</p></th><th align="left" colspan="2"><p>All patients (N = 18)</p></th><th align="left" rowspan="2"><p>Baseline to 24-week mean difference (SE)</p></th><th align="left" rowspan="2"><p>95% CI for mean difference (lower, upper)</p></th><th align="left" rowspan="2"><p>P-value (effect size)</p></th></tr><tr><th align="left"><p>Baseline LS-mean (SE)</p></th><th align="left"><p>Week 24 LS-mean (SE)</p></th></tr></thead><tbody><tr><td align="left"><p>ABC</p></td><td align="left" /><td align="left" /><td align="left" /><td align="left" /><td align="left" /></tr><tr><td align="left"><p> Irritability</p></td><td char="(" align="char"><p>26.05 (2.82)</p></td><td char="(" align="char"><p>18.71 (2.93)</p></td><td char="(" align="char"><p>− 7.34 (1.87)</p></td><td char="(" align="char"><p>(− 11.08, − 3.60)</p></td><td char="(" align="char"><p>< 0.001 (0.87)*<sup>a</sup></p></td></tr><tr><td align="left"><p> Lethargy</p></td><td char="(" align="char"><p>9.69 (1.58)</p></td><td char="(" align="char"><p>6.77 (1.71)</p></td><td char="(" align="char"><p>− 2.92 (1.35)</p></td><td char="(" align="char"><p>(− 5.62, − 0.22)</p></td><td char="(" align="char"><p>0.034 (0.50)*</p></td></tr><tr><td align="left"><p> Stereotypies</p></td><td char="(" align="char"><p>5.96 (1.35)</p></td><td char="(" align="char"><p>2.97 (1.39)</p></td><td char="(" align="char"><p>− 2.99 (0.87)</p></td><td char="(" align="char"><p>(− 4.74, − 1.25)</p></td><td char="(" align="char"><p>0.001 (0.51)*</p></td></tr><tr><td align="left"><p> Hyperactivity</p></td><td char="(" align="char"><p>27.01 (2.55)</p></td><td char="(" align="char"><p>19.45 (2.65)</p></td><td char="(" align="char"><p>− 7.56 (1.77)</p></td><td char="(" align="char"><p>(− 11.12, − 4.01)</p></td><td char="(" align="char"><p>< 0.001 (0.95)*</p></td></tr><tr><td align="left"><p> Inapp. speech</p></td><td char="(" align="char"><p>4.89 (0.76)</p></td><td char="(" align="char"><p>3.76 (0.78)</p></td><td char="(" align="char"><p>− 1.13 (0.56)</p></td><td char="(" align="char"><p>(− 2.26, − 0.01)</p></td><td char="(" align="char"><p>0.049 (0.37) *</p></td></tr><tr><td align="left"><p>HSQ-ASD</p></td><td align="left" /><td align="left" /><td align="left" /><td align="left" /><td align="left" /></tr><tr><td align="left"><p> Per item mean</p></td><td char="(" align="char"><p>2.84 (0.39)</p></td><td char="(" align="char"><p>2.11 (0.42)</p></td><td char="(" align="char"><p>− 0.74 (0.29)</p></td><td char="(" align="char"><p>(− 1.32, − 0.16)</p></td><td char="(" align="char"><p>0.014 (0.48)*</p></td></tr><tr><td align="left"><p>Vineland</p></td><td align="left" /><td align="left" /><td align="left" /><td align="left" /><td align="left" /></tr><tr><td align="left"><p> Communication</p></td><td char="(" align="char"><p>69.18 (5.35)</p></td><td char="(" align="char"><p>75.85 (6.29)</p></td><td char="(" align="char"><p>6.68 (5.67)</p></td><td char="(" align="char"><p>(− 5.30, 18.65)</p></td><td char="(" align="char"><p>0.256 (0.33)</p></td></tr><tr><td align="left"><p> Daily living</p></td><td char="(" align="char"><p>75.72 (4.32)</p></td><td char="(" align="char"><p>78.42 (5.24)</p></td><td char="(" align="char"><p>2.70 (5.08)</p></td><td char="(" align="char"><p>(− 7.91, 13.31)</p></td><td char="(" align="char"><p>0.601 (0.19)</p></td></tr><tr><td align="left"><p> Socialization</p></td><td char="(" align="char"><p>69.17 (4.06)</p></td><td char="(" align="char"><p>72.96 (4.77)</p></td><td char="(" align="char"><p>3.79 (5.56)</p></td><td char="(" align="char"><p>(− 7.70, 15.28)</p></td><td char="(" align="char"><p>0.502 (0.31)</p></td></tr></tbody></table> </ephtml> </p> <p>ABC-Irritability subscale was 1.5 SD above the population mean at Baseline and within 1 SD of the mean at Week 24, demonstrating a clinically meaningful difference *Indicates statistical significance <sups>a</sups>At week 24, 11/18 (61.1%) were much improved (<reflink idref="bib2" id="ref81">2</reflink>) or very much improved (<reflink idref="bib1" id="ref82">1</reflink>)</p> <p>Graph: Fig. 1 Changes in ABC-Irritability scores over the course of treatment. P-values less than 0.05 are *, less than 0.01 are **, and less than 0.001 are ***</p> <p>Graph: Fig. 2 HSQ-ASD Per-Item Mean over the course of treatment. P-values less than 0.05 are *, less than 0.01 are **, and less than 0.001 are ***</p> <hd id="AN0146431865-32">Discussion</hd> <p>Results from this pilot trial support the feasibility and preliminary efficacy of the 24-week RUBI-GPT program for children with ASD and disruptive behavior. The intervention was acceptable to caregivers. Parents actively engaged in treatment sessions, answered questions indicating understanding of session material, and assisted in development of the child's treatment plan. However, homework completion was variable. Some parents had difficulty with homework completion perhaps due to challenges of everyday life. Half of the children in this study lived in single-parent homes with annual incomes less than $40,000. Thus, caregiving and financial responsibilities may have hindered homework completion.</p> <p>Therapists delivered the manual in a consistent fashion as evidenced by 98.8% fidelity on a 20% random sample of sessions scored by independent reviewers.</p> <p>Eighty-nine percent of families completed the 16-week intervention (i.e. 11% attrition from Baseline to Week 16). One additional family dropped out between Week 16 and Week 24 (the follow-up evaluation). Attrition was due to problems with scheduling, transportation or other family circumstances (e.g. caring for aging parents). The overall attrition rate of 16.7% was slightly higher than the pre-specified benchmark of 11%. This pre-specified benchmark was based on results from the highly controlled randomized RUBI-PT trial that provided support for travel to the PT sessions. Moreover, in that trial, PT was delivered in an individual format, which provided greater scheduling flexibility. However, the rate of attrition in the current trial was lower than rates reported in other studies applying evidence-based practices in "real world" settings (Chacko et al. [<reflink idref="bib9" id="ref83">9</reflink>]; de Haan et al. [<reflink idref="bib13" id="ref84">13</reflink>]). These reviews on parenting interventions and other child psychotherapies in clinical settings report dropout rates in as many as 50% of participants. Higher dropout rates in the real-world clinical studies compared to randomized clinical trials (RCTs) are likely due to several reasons. First, parents who enroll their children in RCTs may be more motivated than parents in clinical settings. Second, as in the RUBI-PT study, RCTs may offer incentives to assist with retention (e.g., Brookman-Frazee et al. [<reflink idref="bib8" id="ref85">8</reflink>]; Kennedy-Martin et al. [<reflink idref="bib27" id="ref86">27</reflink>]; Wainer et al. [<reflink idref="bib53" id="ref87">53</reflink>]). Third, strict entry criteria in many RCTs deigned to decrease variability in the study sample may also protect against attrition. Thus, the 16.7% attrition rate in this pilot trial should not be considered unexpected and reflects adequate acceptability (Weisz et al. [<reflink idref="bib60" id="ref88">60</reflink>], [<reflink idref="bib61" id="ref89">61</reflink>]).</p> <p>The children and families in this trial of RUBI-GPT were different in potentially important ways from the RUBI-PT randomized trial (Bearss et al. [<reflink idref="bib6" id="ref90">6</reflink>]). Participants in RUBI-GPT were older than the children in the randomized trial (6.12 ± 1.95 years versus 4.8 ± 1.2). In the current trial, 53% of children were intellectually disabled compared to 25% in the previous trial. Only 56% of children lived in intact, two-parent families compared to 88% in the randomized trial. A majority of the families in RUBI-GPT were African-American (66%), a group historically underrepresented in behavioral parent training research (Coard et al. [<reflink idref="bib11" id="ref91">11</reflink>]; Singer et al. [<reflink idref="bib46" id="ref92">46</reflink>]) and ASD intervention research (Vivanti et al. [<reflink idref="bib52" id="ref93">52</reflink>]). Most caregivers (56%) reported annual incomes below $40,000. The impact of these differences on outcomes is uncertain.</p> <p>Potential benefits of RUBI-GPT were also observed in the parent ratings on the ABC-I and HSQ. The mean baseline ABC-I score of 26 was slightly higher than the mean of 23.7 in the prior RCT. The change from baseline of 7.3-point reduction to 18.7 in RUBI-GRP was smaller than the 11.3-point reduction on the ABC-I in the randomized trial. However, the mean ABC-I at endpoint of 18.7 occurred in context of wide variability. In this small sample, this variability apparently had a large impact on the mean at endpoint. Nonetheless, even with modifications to the original protocol (e.g. elimination of the home visits and combination of some core treatment sessions), and a small sample size, the study findings suggest that RUBI-GPT could expand access to treatment for children with ASD and disruptive behavior. The group format may also be more easily incorporated into community clinics, compared to an individually delivered PT (Gross et al. [<reflink idref="bib16" id="ref94">16</reflink>]). Finally, the outcomes of this time-limited intervention reflect improvement in disruptive behavior rather than core symptoms of ASD, which may be the focus of intensive Applied Behavior Analysis.</p> <p>The group-based delivery model revealed benefits as well as challenges. Participants were enrolled in five treatment waves (3–4 per wave). Group-based treatment requires careful coordination to ensure that parents of children in each successive wave of recruitment can identify a mutually acceptable time to attend PT sessions. The timing of assessments has to be uniform to ensure consistent data collection time points across groups. These practical problems warrant careful consideration in advance of launching a large-scale randomized trial of RUBI-GPT.</p> <p>This study relied on parent-report and independent evaluator ratings rather than direct behavioral observation to assess change in child behavior over time. Our earlier attempts to use a structured behavioral observational sequence, however, were disappointing due to high variability in child behavior in the clinical setting (Handen et al. [<reflink idref="bib19" id="ref95">19</reflink>]; Swiezy et al. personal communication). Despite the entry requirement for disruptive behavior in these prior studies, over 50% of participants did not exhibit disruptive behavior at baseline on our standardized behavioral observation protocol (de Haan et al. [<reflink idref="bib13" id="ref96">13</reflink>]; Swiezy et al. personal communication). The structured clinic-based observational sequence apparently did not reflect the <emph>idiosyncratic</emph> child disruptive behaviors that are targeted in RUBI (e.g., compliance with the morning routine, tantrum at the grocery store, aggression directed specifically toward a sibling). This is not to say that direct observation of behaviors should not be measured at baseline and follow up assessments. To our knowledge, however, there is not yet a protocol available that: is <emph>standardized</emph> (to allow group comparisons); <emph>concise</emph> (i.e. appreciates costs and time demands of coding observational data in large N trials; and <emph>reliably</emph> evokes a <emph>range</emph> of idiosyncratic disruptive behaviors in children with ASD. Additional research is needed to develop new models for collecting valid direct observation data that is suitable for large scale randomized trials in ASD.</p> <p>Additional limitations include the small sample size and lack of control group. In the absence of a control group, it is not possible to separate the effects of treatment from the effect of time or attention on disruptive behavior in this sample of children with ASD. In addition, parent- and clinician-ratings of change in child behavior were not masked. Confidence in the outcome data is bolstered by the availability of independent evaluators who are not involved in the delivery of treatment and are blind to treatment assignment in a randomized trial. In this study, the independent evaluator was not involved in the treatment—but was aware of the child's treatment status.</p> <p>This project fits in with our long-term interest to expand parent training into routine care for young children with ASD and disruptive behavior. Demonstrating the feasibility of RUBI-PT when delivered in a group format in this sample of socioeconomically challenged families is a small but potentially important step toward successful implementation of PT in more representative clinical populations. Future studies would be strengthened by including assessment of adoption of skills presented in parent training. Here again, new models of evaluating parent fidelity that are amendable to large-scale studies may be needed.</p> <p>The efficacy measures used in this pilot trial (ABC-I; HSQ-ASD; CGI-I) were selected to match those used in our previous RUBI-PT trial where these measures demonstrated sensitivity to change in disruptive behavior and differences between PT and Parent Education. To test the efficacy of RUBI-GPT, it would require a large-scale randomized clinical trial, controlling for time and attention, as well as masked approaches to outcome measurement.</p> <hd id="AN0146431865-33">Acknowledgments</hd> <p>This research was conducted through the Marcus Autism Center. We gratefully acknowledge the contributions of the parents and children who participated in this study.</p> <hd id="AN0146431865-34">Author Contributions</hd> <p>TLB, KB, and LS worked on the conceptualization and design of the study, plan of analysis, and interpretation of results. TLB, VP, KB, ANE, and LS implemented study intervention, completed study assessments, and reviewed treatment fidelity. HMR reviewed treatment fidelity and entered data. SG completed all study analyses. All authors participated in the drafting and revising the manuscript and approved of the final manuscript as submitted.</p> <hd id="AN0146431865-35">Compliance with Ethical Standards</hd> <p></p> <hd id="AN0146431865-36">Conflict of interest</hd> <p>Dr. Scahill is a consultant with Roche, Shire, Suupernus, Neurocrine, Janssen, Yamo. He receives royalties from Guilford, Oxford and American Psychological Association.</p> <hd id="AN0146431865-37">Ethical Approval</hd> <p>All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.</p> <hd id="AN0146431865-38">Informed Consent</hd> <p>Informed consent was obtained from all individual participants included in the study.</p> <hd id="AN0146431865-39">Publisher's Note</hd> <p>Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.</p> <ref id="AN0146431865-40"> <title> References </title> <blist> <bibl id="bib1" idref="ref42" type="bt">1</bibl> <bibtext> Aman MG, McDougle CJ, Scahill L, Handen B, Arnold LE, Johnson C. 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  Data: <searchLink fieldCode="AR" term="%22Burrell%2C+T%2E+Lindsey%22">Burrell, T. Lindsey</searchLink> (ORCID <externalLink term="http://orcid.org/0000-0003-0682-2614">0000-0003-0682-2614</externalLink>)<br /><searchLink fieldCode="AR" term="%22Postorino%2C+Valentina%22">Postorino, Valentina</searchLink><br /><searchLink fieldCode="AR" term="%22Scahill%2C+Lawrence%22">Scahill, Lawrence</searchLink><br /><searchLink fieldCode="AR" term="%22Rea%2C+Hannah+M%2E%22">Rea, Hannah M.</searchLink><br /><searchLink fieldCode="AR" term="%22Gillespie%2C+Scott%22">Gillespie, Scott</searchLink><br /><searchLink fieldCode="AR" term="%22Evans%2C+A%2E+Nichole%22">Evans, A. Nichole</searchLink><br /><searchLink fieldCode="AR" term="%22Bearss%2C+Karen%22">Bearss, Karen</searchLink>
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="SO" term="%22Journal+of+Autism+and+Developmental+Disorders%22"><i>Journal of Autism and Developmental Disorders</i></searchLink>. Nov 2020 50(11):3883-3894.
– Name: Avail
  Label: Availability
  Group: Avail
  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/
– Name: PeerReviewed
  Label: Peer Reviewed
  Group: SrcInfo
  Data: Y
– Name: Pages
  Label: Page Count
  Group: Src
  Data: 12
– Name: DatePubCY
  Label: Publication Date
  Group: Date
  Data: 2020
– 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="%22Intervention%22">Intervention</searchLink><br /><searchLink fieldCode="DE" term="%22Parent+Education%22">Parent Education</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="%22Behavior+Problems%22">Behavior Problems</searchLink><br /><searchLink fieldCode="DE" term="%22Parent+Child+Relationship%22">Parent Child Relationship</searchLink><br /><searchLink fieldCode="DE" term="%22Parent+Attitudes%22">Parent Attitudes</searchLink><br /><searchLink fieldCode="DE" term="%22Outcomes+of+Treatment%22">Outcomes of Treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Children%22">Children</searchLink>
– Name: DOI
  Label: DOI
  Group: ID
  Data: 10.1007/s10803-020-04427-1
– Name: ISSN
  Label: ISSN
  Group: ISSN
  Data: 0162-3257
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Delivery of interventions in a group format is a potential solution to limited access to specialized services for children with autism spectrum disorder (ASD). We conducted an open feasibility trial of group-based RUBI parent training in 18 children (mean age 6.12 ± 1.95 years) with ASD and disruptive behaviors. Parents participated in one of five groups (3 to 4 parents per group). Eighty-three percent of participants completed the 24-week trial. Session attendance was moderate (74.2%). All parents indicated that they would recommend the treatment. Therapists demonstrated 98.8% fidelity to the manual. Eleven of 18 (64.7%) participants were rated as much/very much improved by an independent evaluator at Week 24. Preliminary efficacy findings justify further study.
– Name: AbstractInfo
  Label: Abstractor
  Group: Ab
  Data: As Provided
– Name: DateEntry
  Label: Entry Date
  Group: Date
  Data: 2020
– Name: AN
  Label: Accession Number
  Group: ID
  Data: EJ1272159
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=eric&AN=EJ1272159
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      – Type: doi
        Value: 10.1007/s10803-020-04427-1
    Languages:
      – Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 12
        StartPage: 3883
    Subjects:
      – SubjectFull: Intervention
        Type: general
      – SubjectFull: Parent Education
        Type: general
      – SubjectFull: Autism
        Type: general
      – SubjectFull: Pervasive Developmental Disorders
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      – SubjectFull: Behavior Problems
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      – SubjectFull: Parent Child Relationship
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      – SubjectFull: Parent Attitudes
        Type: general
      – SubjectFull: Outcomes of Treatment
        Type: general
      – SubjectFull: Children
        Type: general
    Titles:
      – TitleFull: Feasibility of Group Parent Training for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot
        Type: main
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            – D: 01
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