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

NCT06904508 | Recruiting

• 2 other identifiers: IRB-FY23-24-3257CDMRP-AR230226
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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. 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

Conditions

Autism Spectrum Disorder; Anxiety

Keywords

autism; autism spectrum disorder; anxiety; youth; randomized controlled trial; cognitive behavioral therapy; electroencephalogram

Outcome Measures

Primary Outcomes (5)

• The Screen for Child Anxiety and Related Disorders (SCARED-P/C)

  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.

  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)

  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..

  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)

  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.

  Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)

• Error Related Negativity (ERN) Event-Related Potential (ERP)

  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

  Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)

• Electroencephalogram (EEG) Hemispheric Asymmetry

  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.

  Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)

Secondary Outcomes (3)

• Child Behavior Checklist (CBCL)

  within 2 weeks of intervention completion (up to 14 weeks post first intervention session)

• Emotion Dysregulation Inventory (EDI)

  within 2 weeks of intervention completion (up to 14 weeks post first intervention session)

• Treatment Fidelity

  Each intervention session (up to 14 weeks)

Study Arms (2)

Waitlist-Control Condition

NO INTERVENTION

Waitlist Control (WC) with Treatment-as-Usual (TAU). Participants in the WC arm will continue in their usual services and will be provided with referrals if needed. No specific treatment recommendations will be given.For ethical reasons, after completing the TAU waitlist period, families will be provided with an opportunity to participate in the FYF intervention.

Treatment Condition: Facing Your Fears (FYF) Group

EXPERIMENTAL

The group consists of 4-6 families who will meet for 90-minute weekly sessions for 12-14 weeks. The sessions will focus on psychoeducation and implementing CBT techniques to help autistic youth and their caregivers "face their fears" and tackle their anxiety.

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

Interventions

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

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).

Treatment Condition: Facing Your Fears (FYF) Group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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:

• 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

Sponsors & Collaborators

• Montclair State University: lead
• Children's Hospital of Philadelphia: collaborator
• Drexel University: collaborator

Study Sites (2)

Montclair State University

Montclair, New Jersey, 07043, United States

RECRUITING

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Erin Kang, PhD

  Montclair State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Kang, PhD

CONTACT

973-655-3615; kange@montclair.edu

Arabella Peters, B.A.

CONTACT

petersa6@montclair.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: April 1, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)