Adapting Anxiety Intervention for Youth With Autism for Rapid Response to COVID-19
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|ClinicalTrials.gov Identifier: NCT04666493|
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : December 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Other: Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a 12 week, single site, single group, open-label trial of the Facing Your Fears intervention.|
|Masking:||None (Open Label)|
|Official Title:||Adapting Anxiety Intervention for Youth With Autism for Rapid Response to COVID-19: A Research Project to Provide and Evaluate Virtual Mental Health Care|
|Actual Study Start Date :||December 4, 2020|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||November 30, 2021|
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 Name: Facing Your Fears (FYF)
- Screen for Child Anxiety Related Emotional Disorders (SCARED), Parent version [ Time Frame: SCARED, 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.
- Screen for Child Anxiety Related Emotional Disorders (SCARED), Child version [ Time Frame: SSCARED, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666493
|Contact: Kristina Hyunjee Lee, M.Ed||416-425-6220 ext email@example.com|
|Holland Bloorview Kids Rehabilitation Hospital||Recruiting|
|Toronto, Ontario, Canada, M4G 1R8|
|Contact: Kristina Hyunjee Lee, M.Ed 4164256220 ext 3297 firstname.lastname@example.org|
|Principal Investigator: Evdokia Anagnostou, MD|
|Principal Investigator:||Evdokia Anagnostou, MD||Holland Bloorview Kids Rehabilitation Hospital|