The Reducing Risk Study

Study Overview
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Brief Summary
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The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.

Official Title
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Reducing Risk: A Comprehensive mHealth Sleep Health Intervention for Adolescents at Risk for Depression and Anxiety Disorders

Conditions
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Insomnia, Delayed Sleep Phase

Intervention / Treatment
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* Behavioral: mTranS-C
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exclusion Criteria: any current psychiatric illness currently use of medications or herbs with known effects on sleep hospitalization for substance use or suicide within the past 12 months known sleep apnea unstable major medical conditions current psychotherapy for depression, anxiety or sleep health deficits

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mTranS-C<br>Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention | Behavioral: mTranS-C<br>* MOBILE HEALTH<br>|
| Active Comparator: Control<br>Access to a mobile and computer accessible control intervention that targets coping skills and sleep education. | Behavioral: Control<br>* MOBILE HEALTH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pittsburgh Sleep Quality Index (PSQI) | Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality | baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the PHQ-9 (The 9 Item Patient Health Questionnaire For Depression) | A validated questionnaire measuring depressive symptom severity. The total score ranges between 0 and 19. Scores are rated as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-19). | baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8 | 
| Change in the SCARED (Screen for Child Anxiety Related Disorders) total score | A validated 41-item questionnaire assessing self-report of anxiety in children and adolescents. Individual items are rated 'Not True or Hardly Ever True' (Score 0), 'Somewhat True or Sometimes True' (Score 1), or 'Very True or Often True' (Score 2). Individual response scores are then summed and for a total score. Total scores range from 0 to 82. | baseline, and at months 1, 2, 3 and 8 | 
| Change in cortisol reactivity and recovery in response to a stress exposure | A validated biological measure of stress reactivity and recovery in response to a stress exposure. Changes in cortisol production at 15, 30 and 45 minutes following a stressor will be evaluated. | baseline and at month 3 |