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CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings
NCT05031364 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Behavioral Interventions for Anxiety in Children with Autism (BIACA)
- BEHAVIORAL Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA)
Study Locations (3)
California
- Westside Regional Center — Culver City
- California Autism Professional Training and Information Network (CAPTAIN) — Sacramento
- Naval Medical Center San Diego — San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05031364
The ClinicalTrials.gov registry entry for NCT05031364 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 829 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Autism appearing as the primary indexed condition, and to 2 interventions — of which Behavioral Interventions for Anxiety in Children with Autism (BIACA) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05031364 reports 3 study locations spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05031364 about?
NCT05031364 is a clinical study titled "CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings". 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 ...
What is the current status of trial NCT05031364?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-07-01. Estimated completion is 2026-06-30.
What conditions does trial NCT05031364 study?
This clinical trial studies the following conditions: Autism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05031364?
The interventions under investigation include: Behavioral Interventions for Anxiety in Children with Autism (BIACA) (BEHAVIORAL), Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05031364?
This trial is sponsored by University of California, Los Angeles, which has 829 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05031364 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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