Adapting Anxiety Intervention for Youth With Autism for Rapid Response to COVID-19

Adapting Anxiety Intervention for Youth With Autism for Rapid Response to COVID-19: A Research Project to Provide and Evaluate Virtual Mental Health Care

This study will examine if a virtual delivery of a group Cognitive Behavioural Therapy (CBT) program, specifically using "Facing Your Fears" (FYF) curriculum, is helpful in improving anxiety symptoms for children and youth with ASD. This study will adapt the FYF program for virtual delivery using a platform called "Zoom for Healthcare" and examine its effectiveness.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum

Detailed Description

The research team will adapt the Facing Your Fears (FYF) program, in consultation with program developers, Canadian experts (psychologists) and Holland Bloorview's Research Family Engagement Committee, to allow for virtual delivery of a traditionally in-person intervention. Adaptations will build on preliminary work already piloted by program developers to meet the current needs (e.g., group work with individual support, video practice for exposures, psychoeducation format).

Participants will complete one screening phone call and one videoconferencing (Zoom for Healthcare) call with the research team, where the delegated research staff will introduce the program and obtain consent for interested and eligible participants. Participants will be asked to provide consent, then proceed to the second part of the screening to ensure that potential participants meet all eligibility criteria. It will be made clear to participants that providing consent and assent at this time will not guarantee study enrollment.

Once eligibility is confirmed, participants will be enrolled in the study and be asked to provide the study team with the participant's ASD diagnostic letter via a secure link (using Sync), complete pre-intervention questionnaires before the start of the program, and post-intervention questionnaires after completing the study intervention.

The program will be abbreviated from 14 weeks to 12 weeks to maximize the number of families served during the study period. Each session will be approximately 60-90 minutes (30-45 minutes with parents and children; 30-45 minutes with parents alone). There will be two check-in calls (approximately 30 mins) with each of the families after weeks 7 and 9 of the program. The group facilitators will use the Zoom for Healthcare platform to deliver the intervention virtually.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 1R8
      • Holland Bloorview Kids Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Chronological age between 8 and 13 years (13 yr, 11 mos, 29 days)
2. Have a clinical diagnosis of Autism Spectrum Disorder (ASD)
3. Ability to read at a grade 2 level or above (based on parent report)
4. Verbally fluent at a grade 2 level or above (can speak or respond to questions that are appropriate for a child in grade 2; based on parent report)
5. Child with significant anxiety symptoms as determined by the clinical team
6. To enhance generalizability of our findings, children will be eligible if they present with some other co-morbid psychiatric conditions (see exclusion criteria)
7. If already receiving pharmacological interventions, must meet the following criteria: If receiving concomitant medications for anxiety, must be on a stable dose during the month prior to screening (6 weeks for fluoxetine).

Exclusion Criteria:

1. Being currently enrolled in another active behavioral/ educational/ psychological treatment for anxiety
2. Diagnosis of acute psychosis or conduct disorder, or a primary diagnosis of Obsessive Compulsive Disorder without another anxiety diagnosis or clinically significant level of anxiety.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Facing Your Fears - Open label; All participants in the study will receive 12 weekly sessions of Facing Your Fears intervention, each lasting approximately 1 to 1.5 hour. Each session involves a component with all the parents and children (30-45 minutes) and a separate time with all the parents only (30-45 minutes). Additionally, there will be two check-in calls (30 minutes each) with the families after weeks 7 and 9 of the program.

Other: Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum; The Facing Your Fears program (FYF; Reaven et al. 2011) is a CBT-based group treatment program that has been adapted for the needs of children with high-functioning ASD. The current project will adapt the FYF program for virtual delivery and examine its effectiveness.; Other Names: Facing Your Fears (FYF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen for Child Anxiety Related Emotional Disorders (SCARED), Parent version	The SCARED is a 38-item measure of anxious symptoms, with both child and parent versions. The parent version will be used as a primary outcome measure, administered at pre- and post-intervention.	SCARED, Parent version will be administered at baseline (pre-intervention) and at week 12, (post-intervention) to assess change between two time points.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen for Child Anxiety Related Emotional Disorders (SCARED), Child version	The SCARED is a 38-item measure of anxious symptoms, with both child and parent versions. The child version will be used as a secondary outcome measure, administered at pre- and post-intervention.	SSCARED, Child version will be administered at baseline (pre-intervention) and at week 12, (post-intervention) to assess change between two time points.

Collaborators and Investigators

• Sponsor: Holland Bloorview Kids Rehabilitation Hospital
• Investigators: Principal Investigator: Evdokia Anagnostou, MD, Holland Bloorview Kids Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: ASD; Autism
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: 0240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No