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NCT05031364 · ClinicalTrials.gov registry record · NA
CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings
A NA study of Autism, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 3
- Study locations
NCT05031364: Recruiting NA study of Autism, sponsored by University of California, Los Angeles.
NCT05031364 is a NA study of Autism that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 100 participants, below the 182-participant average among 104 other Autism trials with a reported enrollment target (45% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05031364, a NA study of Autism, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
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
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 |
What NCT05031364 shows while recruiting
NCT05031364 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 182-participant average among 104 other Autism trials with a reported enrollment target (45% lower).
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.
NCT05031364 reports a single indexed study location in California.
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.
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).
Who is sponsoring clinical trial NCT05031364?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Autism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05031364's enrollment target sits among peer trials
100 38th of 104 higher than 64 of 104 other Autism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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