Brain activity changes after cognitive behavioral therapy for anxiety in autistic youth from high-need communities
Electrophysiological Correlates of Anxiety-related Improvements Following Cognitive Behavioral Therapy for Autistic Youth in High-Need Communities
NA · Montclair State University · NCT06904508
This project will test whether a group CBT program called Facing Your Fears reduces anxiety and changes brain activity in autistic kids aged 8–14 from underserved communities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 8 Years to 14 Years |
| Sex | All |
| Sponsor | Montclair State University (other) |
| Locations | 2 sites (Montclair, New Jersey and 1 other locations) |
| Trial ID | NCT06904508 on ClinicalTrials.gov |
What this trial studies
This randomized study compares immediate participation in the Facing Your Fears (FYF) group CBT program to a waitlist control receiving usual care, with the option to receive FYF after the wait period. Participants complete EEG recordings and standardized anxiety measures reported by both youth and parents before and after the intervention period. The team will examine whether changes in EEG patterns correspond to symptom improvement and relate to traits like tolerance for uncertainty and emotion regulation. Caregivers join the intervention alongside their child, and visits occur at Montclair State University and Drexel University.
Who should consider this trial
Good fit: Autistic youth aged 8–14 who are verbally fluent in English, have an estimated verbal IQ of 70 or above, clinically significant anxiety, and a legal guardian able to provide consent and participate in the intervention are ideal candidates.
Not a fit: Children outside the 8–14 age range, those who are nonverbal or have an estimated verbal IQ below 70, or those without clinically significant anxiety are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could reduce anxiety symptoms for participating autistic youth and identify brain-based markers that help tailor treatment in underserved communities.
How similar studies have performed: Behavioral CBT programs including Facing Your Fears have shown symptom improvements for anxiety in autistic youth, but using EEG to track neural change in this underserved population is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between the ages of 8 and 14 * Have significant deficits in reciprocal social behavior as defined by a score of 11 or above on the parent-report SCQ questionnaire * Are verbally fluent in English, enabling them to participate in the appropriate modules (3 or 4) of the researcher-administered ADOS-2 * Have an estimated verbal IQ of 70 or above as determined by the researcher-administered KBIT-2 * Have clinically significant anxiety symptoms as defined by significant elevations on either the parent-report SCARED questionnaire or the parent-report PRAS-ASD questionnaire * Have a legal guardian who can provide consent for their child's participation as well as their own participation in the intervention alongside their child. If the legal guardian is unable to participate in the intervention themselves but would like for their child to receive the intervention with another caregiver who lives with the child, the legal guardian will still be the one to sign the consent form, but will provide permission for another caregiver (logged on the consent form) to participate in the intervention alongside the child Exclusion Criteria: * Fail to meet any of the above inclusion criteria * If it is determined by the research team via parent report or direct observation that the child has a severe medical or psychiatric impairment (e.g., psychosis, severe aggressive behavior, or other severe clinical symptoms) that require more intensive treatment such as day treatment or hospitalization
Where this trial is running
Montclair, New Jersey and 1 other locations
- Montclair State University — Montclair, New Jersey, United States (RECRUITING)
- Drexel University — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Erin Kang, PhD — Montclair State University
- Study coordinator: Erin Kang, PhD
- Email: kange@montclair.edu
- Phone: 973-655-3615
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 Spectrum Disorder, Anxiety, autism, autism spectrum disorder, anxiety, youth, randomized controlled trial, cognitive behavioral therapy