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CBT for Autism (CYAN Trial)

N/A
Recruiting
Led By Wood
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Youth participants will be boys or girls between 6 and 14 years of age with a documented clinical diagnosis of ASD
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sessions 1 [approximately week 1], 5 [approx. week 5], 9 [approx. week 9], and 13 [approx. week 13]
Awards & highlights

CYAN Trial Summary

This trial is testing whether cognitive behavioral therapy is more effective than usual care for treating children with autism and emotional dysregulation.

Who is the study for?
This trial is for children aged 6-14 with autism and emotional challenges like irritability or anxiety. They must have a clinical diagnosis of ASD, meet certain criteria on the Social Responsive Scale-2 and Vineland Adaptive Behavior Scales, and be referred by specific agencies. Clinicians treating these youths should specialize in fields such as psychology or social work.Check my eligibility
What is being tested?
The study compares cognitive behavioral therapy (CBT) designed for emotional dysregulation in autistic children to usual care supplemented by CBT self-instruction. It involves 100 youths treated by clinicians who receive either live expert consultation or use open-access digital/print materials.See study design
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medication, traditional side effects are not a primary concern; however, participants may experience discomfort or stress related to engaging with new therapeutic practices.

CYAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 14 years old and have been diagnosed with ASD.

CYAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sessions 1 [approximately week 1], 5 [approx. week 5], 9 [approx. week 9], and 13 [approx. week 13]
This trial's timeline: 3 weeks for screening, Varies for treatment, and sessions 1 [approximately week 1], 5 [approx. week 5], 9 [approx. week 9], and 13 [approx. week 13] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Brief Problem Monitor (BPM)
Secondary outcome measures
Change in Social Responsiveness Scale II (SRS-II)
Change in Youth Top Problems (YTP) Rating Scale
Consumer Satisfaction Parent Questionnaire
Other outcome measures
Change in BIACA Therapist Quiz
Mixed-methods feedback on training and consultation in BIACA
The Modular EBPs for Youth with Autism Fidelity Scale (MEYA-FS; McLeod et al., 2022)
+1 more

CYAN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Consultation-Based Training on BIACAExperimental Treatment1 Intervention
Community mental health clinicians will be given online one-on-one training and consultation in the BIACA (Behavioral Interventions for Anxiety in Children with Autism; e.g., Wood et al., 2020) CBT program. Clinicians will be provided with weekly 30-minute video-conference-based consultation sessions with an expert in BIACA. These consultation sessions are manual-driven and utilize a Practice-Based Coaching format, in which a trained consultant meets weekly with clinicians to provide practice-based feedback (cf. McLeod et al., 2018). Consultation meetings include agenda setting, case material review, planning for the next treatment session, and a meeting summary. Relevant online training materials (e.g., demonstration videos of CBT sessions; corresponding written session materials) developed in the context of a NIMH R34 grant available on meya.ucla.edu (1R34MH110591) will also be provided to clinicians for each upcoming therapy session.
Group II: Usual Care Augmented by Self-Instruction Resources for CBT for AutismActive Control1 Intervention
Community mental health clinicians in this arm will provide any therapy, counseling, and/or behavioral treatment procedures they deem appropriate for each participating child. Clinicians randomized to this arm will be given immediate access to CBT-for-autism self-instruction materials that are already freely available to any clinician at meya.ucla.edu (see Consultation-Based Training on BIACA arm, above), to supplement their usual clinical care, if they so choose, until they complete their Usual Care/Self-Instruction participation and are offered direct training and weekly consultation in BIACA.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityOTHER
691 Previous Clinical Trials
22,884,653 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
349 Patients Enrolled for Autism Spectrum Disorder
United States Naval Medical Center, San DiegoFED
102 Previous Clinical Trials
25,837 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,279,638 Total Patients Enrolled
25 Trials studying Autism Spectrum Disorder
4,349 Patients Enrolled for Autism Spectrum Disorder

Media Library

CBT Clinical Trial Eligibility Overview. Trial Name: NCT05031364 — N/A
Autism Spectrum Disorder Research Study Groups: Consultation-Based Training on BIACA, Usual Care Augmented by Self-Instruction Resources for CBT for Autism
Autism Spectrum Disorder Clinical Trial 2023: CBT Highlights & Side Effects. Trial Name: NCT05031364 — N/A
CBT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05031364 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this trial extend beyond octogenarians?

"This research project has specific requirements for applicants. Namely, potential participants must be in the age range of 6 to 14 years old. Currently, 169 trials are recruiting patients under 18 and 33 for seniors aged 65 and above."

Answered by AI

How many individuals are being included in this clinical test?

"Affirmative. According to the information hosted by clinicaltrials.gov, this medical trial is actively recruiting participants, having first been posted on July 1st 2021 and most recently updated on October 12th 2022. The study requires 100 volunteers from 3 different sites."

Answered by AI

Is it possible for me to become a participant in this medical study?

"This trial is in search of 100 children between the ages 6 and 14 who have been clinically diagnosed with autism, early infantile. Furthermore, they must fulfill certain criteria including: having a clinician that regularly deals with youth affected by Autism Spectrum Disorder (ASD), being referred to them from a participating agency, exhibiting high scores on both Social Responsive Scale-2 and Vineland Adaptive Behavior Scales-3 Communication Composite Standard Score tests as well as demonstrating symptoms of emotion dysregulation through an Aberrant Behavior Checklist-2 Irritability score."

Answered by AI

Is there availability for enrolment in this research study?

"According to a listing on clinicaltrials.gov, this medical experiment is unceasingly searching for participants. Originally posted on July 1st 2021 and last modified October 12th 2022, the trial seeks volunteers."

Answered by AI

What are the hoped-for outcomes of this research endeavor?

"This trial entails measuring the Change in Brief Problem Monitor (BPM) across a timeframe that includes Baseline (week 0), Session 4 (approx. week 4), Session 8 (approx. week 8), Session 12( approx. week 12), Immediate Post-Treatment [approx. week 16], and Follow up ( approx. week 29). Secondary objectives encompass observing changes in Social Responsiveness Scale II with high internal consistency, convergence to other ASD severity metrics, and ability to discern between those with/without autism; Consumer Satisfaction Parent Questionnaire for parental satisfaction of treatment; as well as Pediatric Anxiety Rating Scale"

Answered by AI

Who else is applying?

What state do they live in?
Ohio
California
How old are they?
18 - 65
< 18
What site did they apply to?
Naval Medical Center San Diego
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
~25 spots leftby Mar 2025