Measuring 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/Actively Recruiting
Led by University of California, Los Angeles · Updated on 2026-02-09
100
Participants Needed
3
Research Sites
8 weeks
Total Duration
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
CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings
W
Wood
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University of California, Los Angeles
Lead Sponsor
Virginia Commonwealth University
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Consultation-Based BIACA | Usual Care + MEYA |
|---|---|---|
| What is it? | A structured cognitive behavioral therapy program, BIACA, delivered by clinicians trained through consultation. It targets anxiety, rigidity, and emotion regulation in children with autism via in vivo exposure, modeling, play-based strategies, and parent/teacher coaching. | Community clinicians use their usual therapeutic approaches, supplemented by self-instruction resources (MEYA) developed to support CBT for youth with autism. MEYA integrates evidence-based elements and allows up to 16 therapy sessions. |
| Primary use | Used to target anxiety, emotional dysregulation, and autism-related difficulties using evidence-based CBT principles, aiming to improve regulation and social skills. | Provides clinicians with tools and resources to deliver CBT interventions for autism, supporting individualized therapy for anxiety and emotional issues. |
| How is it given or performed? | Delivered over 16 weekly sessions including both child and parent(s), with clinicians receiving consultation-based training. Exposure therapy, modeling, and social coaching are adapted for communication abilities. | Clinicians provide up to 16 therapy sessions, incorporating their usual approaches, enhanced by MEYA web-based self-instruction materials. |
| Evidence status | Evidence from randomized trials supports BIACA’s efficacy in reducing anxiety and emotional symptoms in children with autism. Further investigation in community practice is ongoing. | CBT-based interventions in community settings show benefit for youth with autism, though evidence for MEYA as a supplement is still emerging. |
| Important limitations | Requires clinicians to complete consultation-based training and deliver therapy as specified, which may limit scalability. Effectiveness in diverse community care may vary. | Supplemental self-instruction resources may not ensure consistent application of CBT principles. Outcomes depend on clinician engagement and prior experience. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/31755906/University of California, Los Angeles
Lead Sponsor
Virginia Commonwealth University
Collaborating Sponsor