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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 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.

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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.

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

FieldValue
Enrollment Target 100 participants
Start Date 2021-07-01
Est. Completion 2026-06-30
Phase NA

What the Registry Record Tells You About NCT05031364

The ClinicalTrials.gov registry entry for NCT05031364 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 104 other Autism trials with a reported enrollment target (45% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 1 distinct geographic area - top geographies include 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.

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