- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04027075
Mindfulness Mobile App to Reduce Adolescent Substance Use (Rewire)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is growing evidence that interventions based on mindfulness have been an efficacious intervention for a variety of problems, including substance use among adolescents. We propose to adapt and test the feasibility and efficacy of a smart phone application (app) intervention prototype that would help adolescent substance users reduce or quit their substance use through the development of stress reduction, emotion regulation, and mindfulness skills. During the development process, 20 high-risk adolescents will be recruited for participation in focus groups and usability testing of early versions of the app; their initial reactions to content and functionality will help guide final iterations. Rewire is a twelve module program, and each module consists of a teaching component and a practice component. Modules take 5 minutes or less to complete. Module topics include developing an awareness of mind and body states, mindful decision making, and maintaining sobriety.
In this study, the Rewire app will be evaluated with 400 high risk adolescents that are involved in the juvenile justice system; the first 20 adolescents will be involved in the development process and the remaining 380 participants will be randomly and equally assigned to the Rewire condition (n = 190) or the Department of Youth Services standard treatment condition (n = 190). Youth will be assessed at baseline and will be instructed to attempt to reduce substance use with a target quit date of 28 days in the future. The Rewire group will receive instructions for using the app in the 28 days following baseline. All youth will complete 1 and 3 month followups. Assessments will consist of online surveys asking about substance use, emotion regulation, family demographics, and mindfulness practices. The Rewire group will also be asked for their thoughts and opinions on the app. Biochemical verification of self-reported substance use, a urine sample, will be collected at each interview.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dana Smith, PhD
- Phone Number: 2305 541-484-2123
- Email: danas@ori.org
Study Locations
-
-
Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Behavioral Intervention Strategies, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- any gender, age 13-18
- recent involvement with juvenile justice system
- documented substance use
- English speaking
- living in the community (e.g., with biological/adoptive/foster parents)
Exclusion Criteria:
- non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
This group will be asked to use the Rewire app daily in the month following the baseline assessment.
This group will also receive services as usual from the Department of Youth Services.
|
Use of the Rewire app involves completing 12 modules and 12 practice sessions over 30 days.
|
No Intervention: Services as usual
This group will receive services as usual from the Department of Youth Services.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Adolescent Use of Cigarettes and E-Cigarettes
Time Frame: Baseline, 1 month (treatment completion), 3 months
|
Decrease in nicotine use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview
|
Baseline, 1 month (treatment completion), 3 months
|
Change in Adolescent Use of Alcohol
Time Frame: Baseline, 1 month (treatment completion), 3 months
|
Decrease in alcohol use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview
|
Baseline, 1 month (treatment completion), 3 months
|
Change in Adolescent Use of Marijuana
Time Frame: Baseline, 1 month (treatment completion), 3 months
|
Decrease in marijuana use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview
|
Baseline, 1 month (treatment completion), 3 months
|
Change in Adolescent Use of Other Recreational Substances
Time Frame: Baseline, 1 month (treatment completion), 3 months
|
Decrease in substance use as measured by the Youth Substance Use Interview
|
Baseline, 1 month (treatment completion), 3 months
|
Change in Emotion Regulation
Time Frame: Baseline, 1 month (treatment completion), 3 months
|
Increased awareness of and control over emotions as measured by the Difficulties in Emotion Regulation Questionnaire
|
Baseline, 1 month (treatment completion), 3 months
|
Change in Mindfulness Behavior
Time Frame: Baseline, 1 month (treatment completion), 3 months
|
Increase in Mindfulness Behavior as measured by the Five Facet Mindfulness Questionnaire
|
Baseline, 1 month (treatment completion), 3 months
|
Change in Attitude toward Substance Use
Time Frame: Baseline, 1 month (treatment completion), 3 months
|
Increased awareness of normative beliefs and consequences related to drug use as measured by the Adolescent Attitudes Questionnaire
|
Baseline, 1 month (treatment completion), 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate efficacy and feasibility of Rewire app in Substance Use Cessation among High-Risk Adolescents
Time Frame: 1 month (treatment completion)
|
Usability and satisfaction data will be assessed using participant ratings of ease of use, perceived benefits, and likeability.
System log-in data will be used to measure frequency of use.
|
1 month (treatment completion)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dana Smith, PhD, Oregon Research Behavioral Intervention Strategies
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA043288
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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