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

Official title

Electrophysiological Correlates of Anxiety-related Improvements Following Cognitive Behavioral Therapy for Autistic Youth in High-Need Communities

Overview

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

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 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)?

Interventions

• Behavioral Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety
  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).

Primary outcome measures

• 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)]
• Anxiety Scale for Children-Autism Spectrum Disorder Scale (ASC-ASD) [Time frame: 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) [Time frame: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)]
• Error Related Negativity (ERN) Event-Related Potential (ERP) [Time frame: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)]
• Electroencephalogram (EEG) Hemispheric Asymmetry [Time frame: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)]

Secondary outcome measures (3)

• Child Behavior Checklist (CBCL) [Time frame: within 2 weeks of intervention completion (up to 14 weeks post first intervention session)]
• Emotion Dysregulation Inventory (EDI) [Time frame: within 2 weeks of intervention completion (up to 14 weeks post first intervention session)]
• Treatment Fidelity [Time frame: Each intervention session (up to 14 weeks)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 2 centers

• Montclair State University — Montclair
• Drexel University — Philadelphia

Identifiers

NCT: NCT06904508 · IRB-FY23-24-3257 · CDMRP-AR230226

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗