Recruiting

Facing Your Fears

Sponsor:

Montclair State University

Code:

NCT06904508

Conditions

Autism Spectrum Disorder

Anxiety

Eligibility Criteria

Sex: All

Age: 8 - 14

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06904508

Start date

Apr 30, 2025

Status verified date

Jun, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 14

Healthy Volunteers: Not accepted

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

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Waitlist-Control Condition

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.

experimental: Treatment Condition: Facing Your Fears (FYF) Group

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.

Interventions

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Erin Kang, PhD

973-655-3615kange@montclair.edu

Arabella Peters, B.A.

petersa6@montclair.edu

Locations

Montclair State University

Recruiting

Montclair, New Jersey, United States, 07043

Contacts

Erin Kang, PhD

973-655-3615kange@montclair.edu

Drexel University

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Tamara Rosen, PhD

215-571-3401ter32@drexel.edu

More Information

Sponsor

Montclair State University

Last update posted

Jun 25, 2025

Last verified

Jun, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Montclair State University on 2025-06-25.