Status:
RECRUITING
Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth From High-Need Communities
Lead Sponsor:
Montclair State University
Collaborating Sponsors:
Children's Hospital of Philadelphia
Drexel University
Conditions:
Autism Spectrum Disorder
Anxiety
Eligibility:
All Genders
8-14 years
Phase:
NA
Brief Summary
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. Re...
Detailed Description
Aims of the study: * How do brain activity patterns (measured by EEG) relate to anxiety symptoms in autistic youth, as reported by both the youth and their parents? * Will brain activity changes line...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06904508
Start Date
April 30 2025
End Date
September 1 2027
Last Update
June 25 2025
Active Locations (2)
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1
Montclair State University
Montclair, New Jersey, United States, 07043
2
Drexel University
Philadelphia, Pennsylvania, United States, 19104