πŸ›οΈ Verified NIH Record β€’ Updated 2025-11-20

A Cognitive Behavioral Therapy Approach to Addressing Anxiety in Children With ASD and Intellectual Disability (NCT07245160)

Feasibility Study of Addressing Anxiety in Children With ASD and Intellectual Disability Through the Facing Your Fears Program

🟑 Not Yet Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

🩺 Plain-English Summary (8th-Grade Level)

Anxiety can be a debilitating and common concomitant diagnosis in autism spectrum disorders (ASD). Dependent on age and subtype of anxiety, the prevalence of anxiety in individuals with autism ranges between 1.7-84%. Meanwhile, the prevalence rate of intellectual disability (ID) in individuals with ASD ranges between 50-80% based on previous studies. There is an even greater risk of anxiety, ranging between 13.6- 43%, in individuals with ASD and ID. Despite the high prevalence of anxiety within this population, there are limited studies exploring assessments and treatments geared towards addressing anxiety in autism and intellectual disabilities. Previous studies have been limited to children who are identified as high functioning, or identified as low functioning without a concomitant diagnosis of ID. Given this, the present study focuses on the population of individuals with ASD and ID by exploring the feasibility of a CBT intervention designed for individuals with high-functioning autism This pilot study aims at addressing and treating anxiety in children with ASD and intellectual disability through the Facing Your Fears (FYF) intervention. Facing Your Fears is a cognitive behavioral therapy (CBT) program specifically designed to address anxiety symptoms in children with autism. Research exploring the effectiveness of the FYF intervention within the population of individuals with ASD and ID is limited. This study aims at evaluating the feasibility of the Facing Your Fears program to address anxiety in children with ASD and ID, while evaluating the effectiveness of this intervention in larger group settings. The duration of the study will run over two 12-week cycles with study assessments conducted in-person, once a week. The study will involve 5-6 parent-child dyads to make up 10-12 participants per cycle. The child participants must be between the ages of 12-18 years old and have a confirmed diagnosis of ASD that meets DSM-V criteria. The study will commence with a month of recruitment, and a month allotted for collating data and assessments, before and after each 12-week intervention cycle. Evaluations will take place at screening, every study visit, and post intervention. Alongside the study evaluations, weekly sessions will involve didactic and practice sessions, with the last 30 minutes reserved for parent training. The sessions focus on the use and generalization of the taught strategies to address anxious symptoms, and exposure sessions outside of the weekly sessions. At the end of the 12-week cycle, the assessments related to the study outcomes will be administered again to allow investigators to compare and analyze pre- and post-intervention scores.

Who can join: Review the eligibility criteria below.

Location: Children's Hospital- LHSC β€” London, Ontario

Age range: 12 Years to 18 Years

πŸ§ͺ Interventions in This Study

  • Facing your Fears (BEHAVIORAL)
  • Baseline Treatment (BEHAVIORAL)

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (1 Sites)

  • Children's Hospital- LHSC β€” London, Ontario

πŸ“ž Contact the Study Coordinator

Phone: (519) 685-8500

Email: janys.lim@lhsc.on.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—