Evaluating an Internet-based Program for Anxious Adolescents

Study Overview
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Brief Summary
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Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all adolescents by the age of 16. The median age of onset is 11 years, making these disorders some of the earliest to develop. Anxiety disorders can have serious negative effects on a young person's personal relationships, school performance, and family life. These disorders may not be discovered by adolescents, parents and health care providers. Even if anxiety disorders are discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if their anxiety is not treated properly. The investigators will carry out research to test Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can use this treatment from home via the computer. Breathe will include information materials and personalized homework assignments to help anxious adolescents learn ways to manage anxiety. More information can be found and www.TheBreatheStudy.com

Detailed Description
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This study is a randomized controlled trial (RCT) with two groups, an Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a resource webpage (control group; considered treatment as usual for youth waiting for services). The investigators will evaluate several methodological processes and outcomes through the following objectives: To determine the effectiveness of a self-guided Internet-based CBT program with limited telephone and email support in reducing anxiety symptoms among adolescents with mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based webpage. To explore mediators and moderators of the Internet-based CBT program. To determine the effectiveness of a self-guided Internet-based CBT program in improving quality of life as compared to a usual self-help intervention. To determine adherence to a self-guided Internet-based CBT program. To determine the cost-effectiveness of the Internet-based CBT program.

Official Title
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Evaluating an Internet-based Program for Anxious Adolescents: A Randomized Controlled Trial

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Breathe
* Behavioral: Resource Webpage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Score of ≥25 on the Screen for Child Anxiety Related Disorders (SCARED) Ability to read and write English Regular access to a telephone and a computer system with high speed Internet service Ability to use the computer to interact with web material Exclusion Criteria: Positive screen on the Ask Suicide-Screening Questionnaire (ASQ) Positive screen on the Schizophrenia Test and Early Psychosis Indicator (STEPI; modified version) Score of ≥3 on the Alcohol Use Disorders Identification Test Consumption subscale (AUDIT-C) Residence outside of Canada

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathe<br>6 sessions of Internet-based cognitive behavioural therapy (CBT) with limited telephone and e-mail support | Behavioral: Breathe<br>* Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.<br>|
| Active Comparator: Resource webpage<br>Webpage that provides general resources on anxiety | Behavioral: Resource Webpage<br>* Static webpage listing anxiety resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score |  | baseline to 6 weeks post-baseline (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adolescent anxiety using the total MASC 2 score |  | 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up) | 
| Change in quality of life using the Youth Quality of Life Instrument - Short Form (YQOL-SF) |  | baseline to 6 weeks post-baseline (post-intervention), 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up) | 
| User experience | Developed by the investigators, this electronically administered, self-report instrument will assess participant satisfaction (e.g., ease of use, layout, convenience) perceived credibility and impact (e.g., helpfulness, knowledge gains, confidence in the program/website), and adherence and usage (e.g., barriers and facilitators to treatment) with an Internet-based program/webpage. | 6 weeks post-baseline (post-intervention) | 
| Intervention adherence | Intervention adherence will be measured by documenting the number of sessions and homework tasks completed. The investigators will also record the number of tailored sessions completed by each participant (intervention condition) and site visits (control condition). These data will be collected through the intervention's software system. | 6 weeks post-baseline (post-intervention) | 
| health care utilization | Developed by the investigators, this self-report instrument will assess whether participants have accessed health care resources (i.e., met with a psychologist/psychiatrist/family doctor/hospital etc.) and if so, how many times. | baseline, 18 weeks post-baseline |