NCT05031364Active, not recruiting
CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings
Effectiveness of Evidence-Based Mental Health Practices for Youth With Autism Supported by Online Consultation to Practitioners in Community and Navy Clinics
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Jul 2021
- Start date
- 1 Jul 2021
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Autism
- NCT number
- NCT05031364
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Jul 2021 to the primary completion date, 1 Jun 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Criteria the registry did not label
- Clinician's inclusion criteria: All practitioner participants will regularly treat at least some youth with ASD within a recognized field of practice (e.g., clinical psychology, counseling, marital and family therapy, social work) and will serve youth with ASD referred by the Regional Centers, Tricare/NMCSD, or the California public schools. Practitioners will agree to invite one or more potentially eligible families of youth with ASD so that, in total, at least 2 of the new families referred to them participate in the study (i.e., each clinician will aim to have a cluster of two families randomized to the same condition with them; however, the two referrals can be non-parallel and clinicians will not be required to enroll a second client to remain in the study, since there is no way for them to guarantee future enrollment from client families. As needed, additional clinicians can be enrolled in the study to reach the target of 100 youth.). Up to four families per practitioner will be allowed so long as the minimum study enrollment of at least 50 practitioners and 100 client families randomized is met.
- Youth inclusion criteria: Youth participants will be boys or girls between 6 and 14 years of age with a documented clinical diagnosis of ASD and will be newly referred for outpatient services with a participating clinician. Additional eligibility criteria are as follows:
- Youth will have a pre-existing clinical diagnosis of ASD made by an appropriate licensed professional (e.g., clinical psychologist, developmental pediatrician) which will be documented in a report or medical note provided by the family, or confirmed telephonically by the diagnosing professional.
- The parent-reported Social Responsive Scale-2 (SRS-2; Constantino \& Gruber, 2012) Total T-Score will be \> 60 (cut-score maximizing ROC curve parameters for screening for ASD; area under the curve = 98.8%; Schanding et al., 2011).
- Youth will meet criteria for clinically significant emotion dysregulation symptoms as defined by a minimum T-score of 60 on the Externalizing or Internalizing subscales of the parent-reported Brief Problem Monitor (BPM) and at least 15 T-score points over 50 between these two BPM subscales (e.g., Internalizing=60 + Externalizing=55).
- The youth has a Vineland Adaptive Behavior Scales-3 Communication Composite Standard Score \> 60 and Expressive Communication subscale v-score \> 8 (in both cases \> 1st %ile).
Age in the registry: 6 years to 14 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Westside Regional Center Coordinator of this site? Confirm its status | Culver City | United States | Unknown status |
| California Autism Professional Training and Information Network (CAPTAIN) Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Naval Medical Center -San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.