Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT

Study Overview
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Brief Summary
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Anxiety is a common mental health problem for Canadian youth. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all youth by the age of 16. 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 youth, parents and health care providers. Even if anxiety disorders are discovered, youth may not get the right therapy. Anxious youth can become sick if their anxiety is not treated properly. The investigative team will carry out research to test Breathe, their new Internet-based treatment for youth with anxiety problems. Youth can use this treatment at home. Breathe includes information materials and personalized homework assignments to help anxious youth learn ways to manage anxiety. This study is a pilot 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 evaluate the change in youths' anxiety (primary outcome) from pre- to post- intervention. To estimate recruitment and retention rates for a full-scale RCT. To estimate a sample size for a full-scale RCT. To define the minimal clinically important difference (MCID) for the primary outcome measure. To measure intervention acceptability. To determine the use of co-interventions during the trial. To conduct a preliminary economic analysis.

Official Title
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Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: cognitive behavioural therapy
* Other: Internet-based resource page


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV social anxiety, generalized anxiety, anxiety not otherwise specified, or adjustment disorder as the primary clinical problem ability to read and write English regular access to a telephone and a computer system with high speed Internet service ability to use a computer to interact with web material youth aged 13-14 must have a consenting parent Exclusion Criteria: youth with an anxiety problem that is not included above youth who receive cognitive behavioural therapy youth who cannot provide consent

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based CBT<br>Internet-based cognitive behavioural therapy | Behavioral: cognitive behavioural therapy<br>* Internet-based CBT<br>|
| Active Comparator: Internet-based resource page<br>Static webpage | Other: Internet-based resource page<br>* Static webpage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in anxiety at 8 weeks | Anxiety will be measured using the Multidimensional Anxiety Scale for Children (MASC2) | at 8 weeks (i.e., post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate |  | at 27 months | 
| Retention rate |  | at 30 months | 
| Minimal Clinically Important Difference (MCID) | We will ask youth allocated to the intervention arm about a MCID. The MCID represents the minimum change considered meaningful from the youth's perspective such that they consider treatment worth participating in. We will use the MCID to determine intervention effectiveness in a full-scale trial. To estimate the MCID, we will use youths' global ratings of change on a 10-point Likert scale (-5 to +5), a commonly used anchor. | at 8 weeks (i.e., post-intervention) | 
| Intervention acceptability | Satisfaction will be measured to infer intervention acceptability, which will be measured in youth allocated to the treatment arm. A 10-item instrument will measure engagement and sense of privacy, expectations and usefulness, communication, and technical (intervention) management. For 10 statements, a 4-point Likert response format ranging from strongly agree to strongly disagree will be used. Scores will range from 10 to 40 with scores ≥ 30 indicating higher acceptability. | at 8 weeks (i.e., post-intervention) | 
| Co-intervention use | We will ask youth whether they used other health care resources during the study (e.g., emergency department visit, other treatments, medication) and reasons for this use (e.g., unmet need, medication prescribed before the study). | at 8 weeks (i.e., post-intervention) | 
| Resource use/costs | The following will be reviewed: (i) software development and maintenance costs (for intervention maintenance and delivery), (ii) training and personnel costs for intervention, (iii) health care utilization data (e.g., self-reported visits to the emergency department, hospital admission), and (iv) other reported costs reported (i.e., time off from work/school). | at 8 weeks | 
| Intervention adherence | Intervention adherence will also be measured to infer intervention acceptability. Intervention adherence will be measured by documenting the number of modules and homework tasks completed. We will also record the number of tailored modules completed by each youth (treatment arm) and site visits (control arm). These data will be collected through the intervention's software system. | at 8 weeks (i.e., post-intervention) |