RECRUITING

CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effectiveness of Evidence-Based Mental Health Practices for Youth With Autism Supported by Online Consultation to Practitioners in Community and Navy Clinics

Quick Facts

Study Start:2021-07-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05031364

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. For participants presenting with severe comorbid symptomology (e.g., psychotic symptoms), the comorbid conditions cannot be sufficiently severe to warrant immediate treatment or require ongoing medication titration.

Contacts and Locations

Study Contact

Wood
CONTACT
310-882-0537
meya@gseis.ucla.edu

Principal Investigator

Wood
PRINCIPAL_INVESTIGATOR
University of California

Study Locations (Sites)

Westside Regional Center
Culver City, California, 90024
United States
California Autism Professional Training and Information Network (CAPTAIN)
Sacramento, California, 95817
United States
Naval Medical Center San Diego
San Diego, California, 92115
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Wood, PRINCIPAL_INVESTIGATOR, University of California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-07-01
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Autism