Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth
This study is looking at how a group therapy called Facing Your Fears (FYF) affects brain activity and anxiety in autistic youth aged 8 to 14. FYF is a type of cognitive behavioral therapy (CBT) that helps children and teenagers with anxiety. Researchers want to see if brain activity changes are linked to improvements in anxiety after treatment. You might receive the FYF therapy right away, or you might be in a group that continues with your usual care for a while before getting the FYF therapy. The study will measure anxiety levels using questionnaires completed by you and your parents, both at the beginning and after the intervention.
- Study design
- This is an interventional study planning to enroll 60 participants. It compares those receiving immediate FYF therapy to those on a waitlist who receive usual care.
- What's involved
- You will complete assessments at the beginning of the study and within two weeks after the intervention ends, which could be up to 14 weeks after the first therapy session.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be assessed within two weeks of intervention completion, up to 14 weeks after the first intervention session.
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Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth From High-Need Communities
At a glance
Conditions
NCT06904508
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Drexel University
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Montclair State University
Montclair, New Jerseystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Erin Kang, PhD · PRINCIPAL_INVESTIGATOR · Montclair State University
Who to contact
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Inclusion
What this trial measures
- 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)
The Screen for Child Anxiety and Related Disorders - Parent/Child versions (SCARED-P/C) is comprised of five anxiety subscales, including panic, generalized anxiety, separation anxiety, and school avoidance symptoms, and a total anxiety subscale. The SCARED-P and SCARED-C each include 41 items designed to evaluate a child's recent anxiety symptoms. Participants rate their responses on a 3-point Likert scale: 0 (Not True or Hardly Ever True), 1 (Somewhat or Sometimes True), and 2 (Very True or Often True). A total score of 25 or higher is considered indicative of clinically significant anxiety. The SCARED has shown good psychometric properties across autistic and non-autistic samples. It has shown evidence for treatment sensitivity in previous FYF trials, and will be used as a primary outcome measure in this study as well.
- 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)
The Anxiety Scale for Children-Autism Spectrum Disorder Scale (ASC-ASD) is a self- and parent-report measure developed to assess separation anxiety, uncertainty, performance anxiety, and anxious arousal dimensionally in the autistic population. It consists of 25-items (scored 0-3) with higher scores indicating higher anxiety levels..
- 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)
It consists of 25-items (scored 0-3) with higher scores indicating higher anxiety levels. This measure was developed to assess DSM-5 and anxiety symptoms distinct to ASD, specifically this measure takes the unique approach of examining behaviorally oriented anxiety symptoms. This measure has demonstrated reliability and validity in the autism population.
- Error Related Negativity (ERN) Event-Related Potential (ERP)Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
EEG systems will be used to record Error Related Negativity using the Flanker paradigm. The Flanker paradigm involves congruent (50%) and incongruent (50%) trials with arrows facing the same direction as (congruent) or the opposite direction of (incongruent) the target. The order of congruent and incongruent trials will be random. All stimuli will be presented for 200 ms followed by an inter-trial interval that varies randomly from 2,300 to 2,800 ms. The participant will be given detailed task instructions, and receive feedback based on their performance at the end of each block. Error and correct trials will be separately averaged, with the error response as the mean activity between -25 and 75ms after the error response at scalp site where error-related brain activity is maximal. In addition, the correct response negativity (CRN) will be evaluated for the same time window and site on correct trials. The ERN (i.e., the error response minus CRN) will then be calculated for analysis
- Electroencephalogram (EEG) Hemispheric AsymmetryBaseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
Resting EEG data will be collected for 6 minutes alternating between 1-min blocks of eyes open or closed (with the order counterbalanced across subjects). Baseline frontal alpha-band power during eyes-open rest will be calculated across the epoch using wavelet analysis for central frequencies (7.5-12.5 Hz) using 20 logarithmic steps at 7 cycles. To normalize the data, natural log-transformed scores will be calculated. Asymmetry scores were created as Ln(Left) - Ln(Right) for mean alpha power across F3(L)/4(R) and F7(L)/8(R) pairs.