Mindfulness Mobile App to Reduce Adolescent Substance Use (Rewire)

Substance-abusing youth - especially those who are involved in the juvenile justice system - are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal thoughts, attempted suicide, and completed suicide. The proposed Phase II project aims to develop and test the efficacy of a mobile app, called Rewire, that is geared toward helping high risk adolescent substance users reduce or quit their substance use. The Rewire app is 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; it applies a mindfulness approach as the guiding framework for the intervention.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

277

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dana Smith, PhD
  • Phone Number: 2305 541-484-2123
  • Email: danas@ori.org

Study Locations

    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Behavioral Intervention Strategies, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dana Smith, PhD, Oregon Research Behavioral Intervention Strategies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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