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NCT07245160Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 24 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
24 (estimated)
First submitted
22 Sept 2025
Start date
1 Dec 2025
Primary completion date
31 Dec 2026
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Diseases
Autism
NCT number
NCT07245160

What you commit to

  • Study type: Interventional
  • Planned participants: 24
  • From 1 Dec 2025 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Individuals involved in a concurrent interventional study

Other illness

  • Individuals with history of significant suicidal ideations or attempts

Who the study is looking for

  • Children between the ages of 12-18 years
  • Confirmed diagnosis of ASD that meets DSM-V criteria
  • ADOS scores consistent with an ASD diagnosis
  • WASI scores equivalent to 50-70
  • CBCL with T score \>/= 70 for the anxiety subscale
  • MASC-2/SCARED score with T-scores reflecting clinically significant anxiety
  • Not part of another interventional study or clinical trial
  • Stable non-pharmacological therapies for at least 12 weeks
  • Stable pharmacological therapies for at least 8 weeks
  • Will not start new treatment for anxiety, medication or intervention, within the study 12 week study period
  • Consistent parent partner per child throughout the duration of the study

Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Hospital- LHSC
Coordinator of this site? Confirm its status
LondonCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.