Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial.
Jeffrey J Wood, Philip C Kendall, Karen S Wood...
https://pubmed.ncbi.nlm.nih.gov/31755906Actively Recruiting
Phase Not Applicable
Age: 6Years - 14Years
All Genders
ID05031364
Effectiveness of Evidence-Based Mental Health Practices for Youth With Autism Supported by Online Consultation to Practitioners in Community and Navy Clinics
Led by University of California, Los Angeles · Updated on 2026-02-09
100
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
V
Virginia Commonwealth University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of cognitive behavioral therapy (CBT) compared to usual clinical care for children aged 6 to 14 years with autism and emotional difficulties such as irritability and anxiety. This 4-year randomized controlled trial involves 50 mental health clinicians, each treating two children, to assess how well a CBT program designed for emotional regulation and core autism symptoms works in community and Navy clinics. In this study, clinicians are randomly assigned to either a CBT program called Behavioral Interventions for Anxiety in Children with Autism (BIACA) with weekly expert consultation, or to provide usual care supplemented by self-instruction CBT resources available online. The BIACA program includes 16 weekly sessions involving both the child and parents, using exposure therapy and social skills coaching. Usual care clinicians may provide various therapies and have access to CBT self-help materials until they complete their participation. Children and their families will be assessed weekly using the Brief Problem Monitor to track changes in emotional regulation. Additional evaluations occur at screening, mid-treatment, post-treatment, and three months after treatment ends. Researchers will also monitor social responsiveness and parent satisfaction. The study lasts about 29 weeks per participant, with careful monitoring of therapy sessions, outcomes, and overall progress throughout.
CONDITIONS
Brief Title
CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings
Who Can Participate
Age: 6Years - 14Years
All Genders
Eligibility Criteria
You may qualify if you...
- Youth aged 6 to 14 years
- Clinical diagnosis of autism spectrum disorder confirmed by a licensed professional
- Parent-reported Social Responsive Scale-2 Total T-Score over 60
- Clinically significant emotion dysregulation with specific Brief Problem Monitor scores
- Vineland Adaptive Behavior Scales-3 Communication Composite Standard Score above 60 and Expressive Communication subscale v-score above 8
- Youth newly referred for outpatient services with a participating clinician
- Clinicians regularly treat youth with ASD and agree to invite at least 2 eligible families to participate
You will not qualify if you...
- Severe comorbid conditions (e.g., psychotic symptoms) requiring immediate treatment or ongoing medication changes
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 16 weeks
Participants receive weekly cognitive behavioral therapy (CBT) sessions addressing anxiety and autism-related emotional and behavioral needs, including parent and teacher training to support regulation in daily settings. Therapy may include up to 16 weekly sessions, adapted as needed for communication abilities.
Weekly visits for up to 16 weeks
Follow-up
Duration - Approximately 13 weeks
Participants are monitored after completing therapy to assess longer-term outcomes related to emotional and behavioral functioning.
1 visit (in-person) at approximately week 29
Trial Site Locations
Total: 3 locations
1
Westside Regional Center
Culver City, California, United States, 90024
Actively Recruiting
2
California Autism Professional Training and Information Network (CAPTAIN)
Sacramento, California, United States, 95817
Actively Recruiting
3
Naval Medical Center San Diego
San Diego, California, United States, 92115
Actively Recruiting
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Research Team
W
Wood
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial.
Jeffrey J Wood, Jill Ehrenreich-May, Michael Alessandri...
https://pubmed.ncbi.nlm.nih.gov/25526831Toward the implementation of evidence-based interventions for youth with autism spectrum disorders in schools and community agencies.
Jeffrey J Wood, Bryce D McLeod, Sami Klebanoff...
https://pubmed.ncbi.nlm.nih.gov/25526837Measuring anxiety as a treatment endpoint in youth with autism spectrum disorder.
Luc Lecavalier, Jeffrey J Wood, Alycia K Halladay...
https://pubmed.ncbi.nlm.nih.gov/24158679