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

What this study is about

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 (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• Individuals with history of significant suicidal ideations or attempts
• Individuals involved in a concurrent interventional study

Where this trial is running

• Children's Hospital- LHSC, London, Ontario, Canada

Who to contact

Janys Lim, MD · 5196858500 · janys.lim@lhsc.on.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07245160.