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

NCT04666493 | Completed

• 1 other identifier: 0240
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

ASD; Autism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Screen for Child Anxiety Related Emotional Disorders (SCARED), Child version

  SSCARED, Child version will be administered at baseline (pre-intervention) and at week 12, (post-intervention) to assess change between two time points.

Study Arms (1)

Facing Your Fears - Open label

EXPERIMENTAL

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

Interventions

Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum OTHER

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.

Also known as: Facing Your Fears (FYF)

Facing Your Fears - Open label

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Chronological age between 8 and 13 years (13 yr, 11 mos, 29 days)
• Have a clinical diagnosis of Autism Spectrum Disorder (ASD)
• Ability to read at a grade 2 level or above (based on parent report)
• 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)
• Child with significant anxiety symptoms as determined by the clinical team

You may not qualify if:

• 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).
• Being currently enrolled in another active behavioral/ educational/ psychological treatment for anxiety
• 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.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Related Publications (1)

• Brian J, Solish A, Leef J, Nguyen J, Bickle L, Budovitch R, Chan V, Drouillard B, Drumm E, Genore L, Adams RH, Hermolin R, Klemencic N, Lambert M, Lee K, Lim J, Mak-Fan K, O'Neill M, Price S, Pye M, Selezneva E, Taheri A, Anagnostou E. Virtual delivery of group-based cognitive behavioral therapy for autistic children and youth during the COVID-19 pandemic was acceptable, feasible, and effective. Sci Rep. 2025 Feb 27;15(1):7034. doi: 10.1038/s41598-025-88779-7.

  PMID: 40016235 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Evdokia Anagnostou, MD

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 12 week, single site, single group, open-label trial of the Facing Your Fears intervention.

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 14, 2020
• Study Start: December 4, 2020
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)