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

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 — BEHAVIORAL
    FYF 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 Condition
    Waitlist 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) Group
    The 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

Locations (2)

FacilityCityStateZIPSite coordinators
Montclair State UniversityMontclairNew Jersey07043
Erin Kang, PhD
973-655-3615
Drexel UniversityPhiladelphiaPennsylvania19104
Tamara Rosen, PhD
215-571-3401

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