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

NCT06904508 · Montclair State University
In plain English

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Official title
Electrophysiological Correlates of Anxiety-related Improvements Following Cognitive Behavioral Therapy for Autistic Youth in High-Need Communities
About this study
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 up with improvements in anxiety after FYF treatment in autistic youth from underserved communities? * Will brain activity relate to other factors related to anxiety (e.g., a person's ability to handle uncertainty and manage emotions)?
Eligibility 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
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2025-04-30
Estimated completion: 2027-09
Last updated: 2025-06-25
Interventions
Behavioral: Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety
Primary outcomes
  • The Screen for Child Anxiety and Related Disorders (SCARED-P/C) (Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session))
  • Anxiety Scale for Children-Autism Spectrum Disorder Scale (ASC-ASD) (Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session))
  • Parent Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) (Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session))
Sponsor
Montclair State University · other
With: Children's Hospital of Philadelphia, Drexel University
Contacts & investigators
ContactErin Kang, PhD · contact · kange@montclair.edu · 973-655-3615
ContactArabella Peters, B.A. · contact · petersa6@montclair.edu
InvestigatorErin Kang, PhD · principal_investigator, Montclair State University
All locations (2)
Montclair State UniversityRecruiting
Montclair, New Jersey, United States
Drexel UniversityRecruiting
Philadelphia, Pennsylvania, United States
Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth From High-Need Communities · TrialPath