The Rewire Study (Mindfulness Mobile App to Reduce Adolescent Substance Use)

Study Overview
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Brief Summary
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The current proposal is aimed at developing a substance use cessation app (Rewire) for high risk adolescents who are involved in the juvenile justice system. The Rewire app will be based on the primary substance use cessation components tested in our previous work with juvenile justice-involved adolescents and on intervention components shown to be central to smoking cessation.

Detailed Description
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The Rewire Study will recruit 60 youth (30 boys and 30 girls) who have had contact with the Department of Youth Services in the last year. Consent will be obtained from parents or guardians for the youths' participation. The participating teens will come to Oregon Research Institute for a baseline assessment. During this visit, the teens will complete an assent form and spend spent 20-30 minutes completing an online survey with an assessor; topics covered in the survey include emotion regulation and drug and alcohol use. Teens will have the app loaded onto their phones and be provided with instructions for its use during this visit. Participants are asked to use the app over the next 2 weeks, completing 4 modules and spending 5-10 minutes each day answering questions about recent emotions and substance use. Teens will be contacted via email for follow up assessments at 2 weeks and 2 months post-baseline. These emails will contain links to the follow-up survey which also asks about emotion regulation and drug and alcohol use; surveys should take 20-30 minutes to complete.

Official Title
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Mindfulness Mobile App to Reduce Adolescent Substance Use

Conditions
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Adolescent Substance Use

Intervention / Treatment
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* Behavioral: Rewire App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 13 to 17 involved with Juvenile Justice system documented substance use English-speaking living in the community Exclusion Criteria: non English-speaking living in treatment or detention facility

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All 60 teens in The Rewire Study will complete the first 4 modules of the Rewire app. Prior to using the app, they will complete a baseline assessment. Follow up surveys will be completed at 2 weeks and 8 weeks post-baseline. Survey topics include drug and alcohol use, emotion regulation, mindfulness and stress, app usability and participant satisfaction.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App Evaluation<br>All 60 teens in The Rewire Study will complete the first 4 modules of the Rewire app. Prior to using the app, they will complete a baseline assessment. Follow up surveys will be completed at 2 weeks and 8 weeks post-baseline. | Behavioral: Rewire App<br>* A prototype Rewire app will be designed and created; the first four modules will be evaluated by 60 high-risk adolescents. The teens are asked to complete each module and spend a few minutes each day for two weeks using the practice exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Adolescent Attitudes toward Substance Use | Adolescent Attitudes toward Substance Use measures beliefs about social norms and consequences. Higher scores represent more prosocial attitudes. | Baseline, 2 weeks, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Adolescent Mindfulness Practices | Mindfulness is measured by the Five Facet Mindfulness Questionnaire. The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Maximum score is 40 for the first 4 scales and 35 for the last. Higher scores indicate a greater tendency toward each element of mindfulness. | Baseline, 2 weeks, 8 weeks | 
| Changes in Emotion Regulation | Emotion Regulation is measured by the Difficulties in Emotion Regulation Scale. Higher scores indicate greater problems with emotion regulation. Total score will range from 77 to 121. | Baseline, 2 weeks, 8 weeks | 
| Evaluate first 4 modules of prototype app | Participant satisfaction ratings are collected through interview questions | Intervention period (time of app use) is from Baseline to 2 week follow up |