Autism Spectrum Disorder Clinical Trial
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 30, 2021 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 13 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Evdokia Anagnostou |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | SSCARED, Child version will be administered at baseline (pre-intervention) and at week 12, (post-intervention) to assess change between two time points. |
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