Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth From High-Need Communities

Recruiting now · Not applicable

Conditions studied: Autism Spectrum Disorder, Anxiety

In brief

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 facts

Study ID

NCT06904508

Run by

Montclair State University

People needed

60

Starts

2025-04-30

Expected to finish

2027-09-01

Last updated by the study team

2025-06-25

Who can join

Age: 8 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Montclair State University — Montclair, New Jersey, United States (enrolling)
• Drexel University — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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