Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth From High-Need Communities
Part of paid clinical trials in Montclair, New Jersey.
- Sponsor
- Montclair State University
- Study ID
- NCT06904508
- Status
- Recruiting
Conditions
- Anxiety
- Autism Spectrum Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 8 Years - 14 Years
- Healthy Volunteers
- Not accepted
Interventions
- Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety — BEHAVIORALFYF is an outpatient, multi-family, evidence-based CBT group treatment for children and adolescents ages 8-14 with average intellectual abilities, and a primary co-occurring anxiety diagnosis (social, generalized, separation anxiety, or specific phobia).
Study Details
The goal of this clinical trial is to investigate neural constructs related to anxiety symptoms in response to Facing Your Fears (FYF) treatment in autistic participants with co-occurring anxiety. Researchers will compare participants receiving immediate FYF intervention to those in the waitlist control group (receiving treatment as usual) to see if there are differences in neural constructs and anxiety symptom changes over the study period. Participants will: * Complete the Facing Your Fears (FYF) intervention if assigned to the immediate treatment group * Continue their usual treatment during a waitlist period if assigned to the control group, followed by the opportunity to participate in FYF intervention after the waiting period ends * Complete assessments of neural constructs, anxiety symptoms, and other measures
Key Dates
- Start date
- Apr 30, 2025
- Status verified
- Jun 2025
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- No Intervention: Waitlist-Control ConditionWaitlist Control (WC) with Treatment-as-Usual (TAU). Participants in the WC arm will continue in their usual services and will be provided with referrals if needed. No specific treatment recommendations will be given.For ethical reasons, after completing the TAU waitlist period, families will be provided with an opportunity to participate in the FYF intervention.
- Experimental: Treatment Condition: Facing Your Fears (FYF) GroupThe group consists of 4-6 families who will meet for 90-minute weekly sessions for 12-14 weeks. The sessions will focus on psychoeducation and implementing CBT techniques to help autistic youth and their caregivers "face their fears" and tackle their anxiety.
Primary Outcome Measure
The Screen for Child Anxiety and Related Disorders (SCARED-P/C) [ Time Frame: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session) ]
Central Contacts
- Erin Kang, PhD973-655-3615
- Arabella Peters, B.A.
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Montclair State University | Montclair | New Jersey | 07043 | |
| Drexel University | Philadelphia | Pennsylvania | 19104 |
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