NCT05031364 · University of California, Los Angeles
CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings
(CYAN)
What this study is about
This study is a 4-year randomly assigned, 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).
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Exclusion criteria
- 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.
Where
- Culver City, California
- Sacramento, California
- San Diego, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 9, 2026 · Source of record for eligibility and locations