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

NCT07245160 | Not Yet Recruiting

• 1 other identifier: HSREB #124721
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

autism spectrum disorder; ASD; anxiety; cognitive behavioral therapy; intellectual disability

Outcome Measures

Primary Outcomes (2)

• Changes in score on the Screen for Child Anxiety Related Disorders (SCARED)

  The SCARED is a 41-item child and parent reported questionnaire that assesses anxiety disorders in childhood and adolescence. A total score on each scale of 25 or higher may indicate the presence of an anxiety disorder. The items reflect domains of anxiety such as panic disorder, generalized anxiety disorder, separation anxiety disorder, social anxiety disorder and school avoidance. For example, a score of 3 for items 11, 17, 36 may indicate significant school avoidance. Pre and post intervention scores (i.e., total and domain specific) will be compared for clinical significance. A lower total score post-intervention may indicate improvement or reduction in anxiety symptoms. A drop of 5-10 points or more in total score may be clinically meaningful, depending on baseline severity. Changes in scores within the domains reflect how specific anxiety symptoms have responded to intervention. Lower domain scores post-intervention would suggest a positive change within that domain.

  SCARED will be administered at screening, at Week 6, and then at Week 12.

• Changes in Multidimensional Anxiety Scale for Children | Second Edition (MASC-2) score

  The MASC-2 is a 50-item child and parent reported questionnaire that assesses the presence of symptoms related to anxiety disorders in domains such as separation and social anxiety, general anxiety disorder, harm avoidance, obsessions and compulsions and physical symptoms. Raw scores for each item are converted to T-scores, percentiles and confidence intervals. Elevated T-scores in one or more domains suggest which type of anxiety is likely prominent. The scale will be administered pre-intervention, during intervention and post-intervention. A lower score post-intervention may indicate an improvement or reduction in anxiety symptoms. Lower total T-scores suggest a general decrease in overall anxiety symptoms compared to baseline. Lower subscale scores (e.g., Social Anxiety, Separation Anxiety, etc.) suggest a symptom reduction in the specific domains. A lower score may not mean full remission, but significant symptom relief (e.g., improved functionality and emotional regulation).

  MASC-2 test retest intervals are 3 weeks- 3 months. The assessment will be administered at screening and at the end of the study (Week 12).

Secondary Outcomes (1)

• Changes in the Child Behavior Checklist (CBCL) scores.

  CBCL has a test-retest interval of 6 months. The measure will be done at screening, EOS (week 12) and post-intervention (Week 24).

Study Arms (2)

Cognitive Behavioral Intervention

EXPERIMENTAL

The experimental condition is a cognitive behavioral therapy intervention that is typically geared for children with ASD without intellectual disability. The established CBT, Facing Your Fears, supports participants in the following key areas: 1) building emotional regulation, 2) developing cognitive tools such as positive self-talk and affirmations, 3) enhancing coping strategies adapted to individual sensory and regulatory profiles, and 4) engaging in gradual exposure to situations or stimuli. The experimental condition will apply the Facing Your Fears model to children with ASD and intellectual disability.

Behavioral: Facing your Fears

Wait-List Control

OTHER

A wait-list control design is employed to ethically evaluate the impact of a CBT intervention. Participants are initially screening using a comprehensive battery of standardized assessments to establish baseline functioning. The assessments include the SCARED/ MASC-2 to evaluate anxiety symptoms; CBCL to evaluate emotional behavioral problems; PedsQL to measure health-related quality of life; ADOS to support diagnostic clarity for autism spectrum characteristics; and the WASI to assess cognitive function and IQ. Following this pre-intervention phase, participants enter a wait-list control period where they do not receive the CBT intervention. The waiting period serves as the control condition, providing natural comparison for later outcomes. Once their cycle is assigned, the same participants transition into the experimental phase.

Behavioral: Baseline Treatment

Interventions

Facing your Fears BEHAVIORAL

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.

Cognitive Behavioral Intervention

Baseline Treatment BEHAVIORAL

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.

Wait-List Control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Children's Hospital- LHSC

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• Reaven J, Blakeley-Smith A, Leuthe E, Moody E, Hepburn S. Facing your fears in adolescence: cognitive-behavioral therapy for high-functioning autism spectrum disorders and anxiety. Autism Res Treat. 2012;2012:423905. doi: 10.1155/2012/423905. Epub 2012 Oct 3.

  PMID: 23091719 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Intellectual Disability; Anxiety Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Janys Lim, MD

CONTACT

5196858500; janys.lim@lhsc.on.ca

Kayleigh Tam, BA

CONTACT

5196858500; kayleigh.tam@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)