RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-04-30
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06904508

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 8 and 14
  2. * Have significant deficits in reciprocal social behavior as defined by a score of 11 or above on the parent-report SCQ questionnaire
  3. * Are verbally fluent in English, enabling them to participate in the appropriate modules (3 or 4) of the researcher-administered ADOS-2
  4. * Have an estimated verbal IQ of 70 or above as determined by the researcher-administered KBIT-2
  5. * Have clinically significant anxiety symptoms as defined by significant elevations on either the parent-report SCARED questionnaire or the parent-report PRAS-ASD questionnaire
  6. * 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
  1. * Fail to meet any of the above inclusion criteria
  2. * 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

Contacts and Locations

Study Contact

Erin Kang, PhD
CONTACT
973-655-3615
kange@montclair.edu
Arabella Peters, B.A.
CONTACT
petersa6@montclair.edu

Principal Investigator

Erin Kang, PhD
PRINCIPAL_INVESTIGATOR
Montclair State University

Study Locations (Sites)

Montclair State University
Montclair, New Jersey, 07043
United States
Drexel University
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Montclair State University

  • Erin Kang, PhD, PRINCIPAL_INVESTIGATOR, Montclair State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-30
Study Completion Date2027-09

Study Record Updates

Study Start Date2025-04-30
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Anxiety