CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings
- Conditions
- Autism
- Interventions
- Behavioral: Behavioral Interventions for Anxiety in Children with Autism (BIACA)Behavioral: Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA)
- Registration Number
- NCT05031364
- Lead Sponsor
- University of California, Los Angeles
- Brief Summary
This study is a 4-year randomized, controlled trial comparing cognitive behavioral therapy (CBT) to usual clinical care for children (aged 6-14 years) with autism and emotional dysregulation (e.g., irritability, anxiety). We will randomly assign 50 mental health clinicians, each treating 2 youth (N = 100 youth total), to CBT program for emotional dysregulation and core autism symptoms with weekly live consultation with an expert or to usual clinical care augmented by self-instruction in CBT, in a 1:1 allocation. The CBT manual is well-supported in our efficacy research, has been replicated in other centers, is free/open-access (meya.ucla.edu), and has user-friendly digital and traditional print materials for mental health clinicians (e.g., psychologists, counselors) to use in preparing for and conducting therapy sessions. The primary outcome measure will be assessed weekly. Additional assessments will occur at Screening, Mid-treatment, Post- treatment and 3-month Follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
- For participants presenting with severe comorbid symptomology (e.g., psychotic symptoms), the comorbid conditions cannot be sufficiently severe to warrant immediate treatment or require ongoing medication titration.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Consultation-Based Training on BIACA Behavioral Interventions for Anxiety in Children with Autism (BIACA) Community mental health clinicians will be given online one-on-one training and consultation in the BIACA (Behavioral Interventions for Anxiety in Children with Autism; e.g., Wood et al., 2020) CBT program. Clinicians will be provided with weekly 30-minute video-conference-based consultation sessions with an expert in BIACA. These consultation sessions are manual-driven and utilize a Practice-Based Coaching format, in which a trained consultant meets weekly with clinicians to provide practice-based feedback (cf. McLeod et al., 2018). Consultation meetings include agenda setting, case material review, planning for the next treatment session, and a meeting summary. Relevant online training materials (e.g., demonstration videos of CBT sessions; corresponding written session materials) developed in the context of a NIMH R34 grant available on meya.ucla.edu (1R34MH110591) will also be provided to clinicians for each upcoming therapy session. Usual Care Augmented by Self-Instruction Resources for CBT for Autism Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA) Community mental health clinicians in this arm will provide any therapy, counseling, and/or behavioral treatment procedures they deem appropriate for each participating child. Clinicians randomized to this arm will be given immediate access to CBT-for-autism self-instruction materials that are already freely available to any clinician at meya.ucla.edu (see Consultation-Based Training on BIACA arm, above), to supplement their usual clinical care, if they so choose, until they complete their Usual Care/Self-Instruction participation and are offered direct training and weekly consultation in BIACA.
- Primary Outcome Measures
Name Time Method Change in Brief Problem Monitor (BPM) Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29) The BPM (Achenbach et al., 2011) is an abbreviated version of the widely used Child Behavior Checklist (CBCL; Achenbach \& Rescorla, 2001). The sum of the parent-report BPM Internalizing and Externalizing subscales will be utilized as the primary outcome measure in this study to index improvement across core aspects of children's mental health (i.e., anxiety, irritability, depressed mood, defiance). The BPM is comprised of 19 items. Each item is rated 0 = not true, 1 = somewhat true, or 2 = very true. Higher scores reflect more problems. Research suggests the BPM has good reliability and validity and is sensitive to change in effectiveness studies of youth psychotherapy (Piper et al., 2014; Weisz et al., 2012). The BPM can be administered remotely via the internet.
- Secondary Outcome Measures
Name Time Method Consumer Satisfaction Parent Questionnaire Immediate Post-Treatment [approximately week 16] Parent satisfaction with treatment will be assessed with an 11-item parent-report measure.
Change in Youth Top Problems (YTP) Rating Scale Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29) The YTP approach is a valid and reliable personalized assessment method that is sensitive to psychotherapy treatment response in children that allows clinicians and researchers to identify problems of the children or adolescents that are especially important from the perspective of a caregiver (Weisz et al., 2011,2012). The YTP caregiver interview (YTP-P) will be administered after Vineland and SACA at screening. This interview allows caregivers to state in their own words what "current" symptoms/problems experienced by their child are the most concerning to them. The specific problems are transcribed in the parents' own words. Interviewers then obtain Initial YTP Symptom Severity Ratings for each problem on a scale ranging from 0 (not at all) to 10 (very, very much). The top 12 problems will then be rated weekly throughout the child's therapy by the caregiver. Higher scores reflect more significant problems.
Change in Social Responsiveness Scale II (SRS-II) Baseline (week 0), Session 8 (approximately week 8), Immediate Post-Treatment [approx. week 16], and Follow-up (approx. week 29) The SRS-II (Constantino \& Gruber, 2012) is a 65-item parent-rated scale measuring the severity of ASD symptoms. The SRS-II has high internal consistency, convergence with other measures of ASD severity, and discriminates between youth with and without ASD (Schanding et al., 2011). It has shown treatment sensitivity in all extant clinical trials of BIACA including the replications by Storch and colleagues; versus treatment-as-usual; and versus standard-of-practice CBT (e.g., Storch et al., 2013, 2015; Wood et al., 2009b, 2015a, 2020).
Trial Locations
- Locations (3)
Westside Regional Center
🇺🇸Culver City, California, United States
California Autism Professional Training and Information Network (CAPTAIN)
🇺🇸Sacramento, California, United States
Naval Medical Center San Diego
🇺🇸San Diego, California, United States