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

Primary Purpose

Autism Spectrum Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum
Sponsored by
Evdokia Anagnostou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring ASD, Autism

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Holland Bloorview Kids Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Facing Your Fears - Open label

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 11, 2020
Last Updated
December 11, 2020
Sponsor
Evdokia Anagnostou
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1. Study Identification

Unique Protocol Identification Number
NCT04666493
Brief Title
Adapting Anxiety Intervention for Youth With Autism for Rapid Response to COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Evdokia Anagnostou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
ASD, Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a 12 week, single site, single group, open-label trial of the Facing Your Fears intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Facing Your Fears - Open label
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum
Other Intervention Name(s)
Facing Your Fears (FYF)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Screen for Child Anxiety Related Emotional Disorders (SCARED), Parent version
Description
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.
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.
Secondary Outcome Measure Information:
Title
Screen for Child Anxiety Related Emotional Disorders (SCARED), Child version
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 To enhance generalizability of our findings, children will be eligible if they present with some other co-morbid psychiatric conditions (see exclusion criteria) 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Hyunjee Lee, M.Ed
Phone
416-425-6220
Ext
3297
Email
klee@hollandbloorview.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evdokia Anagnostou, MD
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Hyunjee Lee, M.Ed
Phone
4164256220
Ext
3297
Email
klee@hollandbloorview.ca
First Name & Middle Initial & Last Name & Degree
Evdokia Anagnostou, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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