Cognitive behavioral therapy for children with autism and emotional needs
Effectiveness of Evidence-Based Mental Health Practices for Youth With Autism Supported by Online Consultation to Practitioners in Community and Navy Clinics
NA · University of California, Los Angeles · NCT05031364
This study is testing if cognitive behavioral therapy can help children with autism and emotional challenges feel better compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 14 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles (other) |
| Locations | 3 sites (Culver City, California and 2 other locations) |
| Trial ID | NCT05031364 on ClinicalTrials.gov |
What this trial studies
This study is a four-year randomized controlled trial that compares cognitive behavioral therapy (CBT) to standard clinical care for children aged 6-14 years with autism and emotional dysregulation. A total of 100 youth will be treated by 50 mental health clinicians, who will be randomly assigned to either the CBT program or usual care supplemented by self-instruction in CBT. The CBT program is designed to address emotional dysregulation and core autism symptoms, with weekly consultations from an expert. Outcomes will be measured weekly, with additional assessments at various stages throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-14 years diagnosed with autism and experiencing emotional dysregulation.
Not a fit: Patients who do not have autism or those who do not exhibit emotional dysregulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective therapeutic approach to improve emotional regulation and overall well-being in children with autism.
How similar studies have performed: Previous studies have shown success with similar CBT approaches for children with autism, indicating that this method is well-supported in the literature.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 1. 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. 2. 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). 3. 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). 4. 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 this trial is running
Culver City, California and 2 other locations
- Westside Regional Center — Culver City, California, United States (RECRUITING)
- California Autism Professional Training and Information Network (CAPTAIN) — Sacramento, California, United States (RECRUITING)
- Naval Medical Center San Diego — San Diego, California, United States (RECRUITING)
Study contacts
- Principal investigator: Wood — University of California
- Study coordinator: Wood
- Email: meya@gseis.ucla.edu
- Phone: 310-882-0537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism