A Cognitive Behavioral Therapy Approach to Addressing Anxiety in Children With ASD and Intellectual Disability
NCT07245160 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-11-24
Summary
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.
Conditions
- Autism Spectrum Disorder (ASD)
- Intellectual Disability
Interventions
- BEHAVIORAL
-
Facing your Fears
The Facing Your Fears intervention is a cognitive behavioral therapy program for children with ASD that is designed to establish somatic and emotional regulation strategies and enhance the use of personalized cognitive coping mantras through a gradual exposure to feared or anxiety provoking situations. The FYF program was developed for children with ASD, but prior research did not assess the feasibility of applying this intervention in children with ASD and intellectual disability. The intervention in the experimental condition will apply this core foundation of the FYF intervention to children with ASD and intellectual disability.
- BEHAVIORAL
-
Baseline Treatment
The wait-list control condition is utilized as a baseline treatment phase where participants undergo a comprehensive battery of standardized assessments to establish baseline functioning. The SCARED/ MASC-2, CBCL and PedsQL is used to assess anxiety symptoms, identify co-occurring issues (e.g., aggression and attention problems) and overall well-being and functioning. Assessments such as the ADOS and WASI are semi-structured, direct observations, which confirm ASD diagnosis for study eligibility and estimates general cognitive ability and IQ. The results from these assessments will confirm eligibility for the study and provide baseline results for post-intervention analysis. The purpose of this pre-intervention phase is to establish a detailed baseline of each participant's functioning across key domains, provide diagnostic clarity and control for confounding variables (e.g., IQ), and enable analysis through pre and post comparison to assess the proposed intervention's effectiveness.
Sponsors & Collaborators
-
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-01
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Canada
Study Locations
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