Autism Spectrum DisorderNCT04666493
Adapting Anxiety Intervention for Youth With Autism for Rapid Response to COVID-19
A study testing Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum in people with Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteCanada
- Study dates
- 4 Dec 2020to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
About this study
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
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum
- Keywords
- ASD, Autism
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculumOther
Also called Facing Your Fears (FYF)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: SSCARED, Child version will be administered at baseline (pre-intervention) and at week 12, (post-intervention) to assess change between two time points.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start4 Dec 2020
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a 12 week, single site, single group, open-label trial of the Facing Your Fears intervention.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evdokia Anagnostou, MD, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666493
- Sponsor's protocol ID
- 0240
- Status last verified
- Jul 2025
- First submitted
- 11 Dec 2020
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40016235
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04666493
- Acronym / sponsor ID
- 0240
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a 12 week, single site, single group, open-label trial of the Facing Your Fears intervention.
| Arm | Type | Receives |
|---|---|---|
| Facing Your Fears - Open label | Experimental | Other: Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculumAll 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. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculumAlso: Facing Your Fears (FYF)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 | Facing Your Fears - Open label |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Derived from this study: PubMed 40016235Brian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evdokia Anagnostou, MD principal investigator
Holland Bloorview Kids Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum in people with Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.