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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04666493
Enrollment
101
Registered
2020-12-14
Start date
2020-12-04
Completion date
2022-01-30
Last updated
2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

ASD, Autism

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.

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.

Interventions

OTHERCognitive 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.

Sponsors

Holland Bloorview Kids Rehabilitation Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Screen for Child Anxiety Related Emotional Disorders (SCARED), Parent versionSCARED, Parent version will be administered at baseline (pre-intervention) and at week 12, (post-intervention) to assess change between two time points.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.

Secondary

MeasureTime frameDescription
Screen for Child Anxiety Related Emotional Disorders (SCARED), Child versionSSCARED, Child version will be administered at baseline (pre-intervention) and at week 12, (post-intervention) to assess change between two time points.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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026