CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings
Part of paid clinical trials in Culver City, California.
- Sponsor
- University of California, Los Angeles
- Study ID
- NCT05031364
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 14 Years
- Healthy Volunteers
- Not accepted
Interventions
- Behavioral Interventions for Anxiety in Children with Autism (BIACA) — BEHAVIORALIn the BIACA CBT program (e.g., Wood et al., 2020), clinicians work with families for 16 weekly sessions that include both the child and parent(s). In BIACA, anxiety, rigidity and inflexible routines, and irritability are all addressed using in vivo exposure therapy strategies during sessions as well as parent (and teacher) training to promote regulation across settings. ASD-related clinical needs that can impact mental health and emotion regulation such as friendship skills and social entry skills (e.g., joining games at school) are addressed with modeling, self-management, and parent- (or teacher-) implemented social coaching in daily settings. For youth with limited communication, therapy is adapted through the use of play-based representations of challenging situations and an emphasis on more action-oriented exposure therapy.
- Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA) — BEHAVIORALParticipating clinicians are expected to have varied training in numerous psychological therapy procedures (e.g., insight-oriented procedures, cognitive interventions, family therapy, etc.), any or all of which they may choose to implement with a participating child. These practices will be characterized through the Therapy Procedures Checklist (Weersing et al., 2002). Additionally, participating clinicians will be provided with information about self-instruction resources on CBT for children with autism, namely, the Modular Evidence-Based Practices for Youth with Autism (MEYA) website developed by our research group. MEYA is freely accessible to clinicians worldwide at meya.ucla.edu. MEYA incorporates treatment elements of both BIACA (Wood et al., 2020) and SEBASTIEN (Wood et al., 2021), which was designed to address additional autism-related clinical needs (e.g., reciprocal conversation). Clinicians in this arm will provide up to 16 therapy sessions.
Study Details
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.
Key Dates
- Start date
- Jul 1, 2021
- Status verified
- Feb 2026
- Primary completion
- May 1, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Consultation-Based Training on BIACACommunity 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.
- Active Comparator: Usual Care Augmented by Self-Instruction Resources for CBT for AutismCommunity 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 Measure
Change in Brief Problem Monitor (BPM) [ Time Frame: Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29) ]
Central Contacts
- Wood310-882-0537
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Westside Regional Center | Culver City | California | 90024 | |
| California Autism Professional Training and Information Network (CAPTAIN) | Sacramento | California | 95817 | |
| Naval Medical Center San Diego | San Diego | California | 92115 |
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