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Mindfulness Mobile App to Reduce Adolescent Substance Use (Rewire)

Primary Purpose

Adolescent Drinking, Adolescent Problem Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rewire app users
Sponsored by
Oregon Research Behavioral Intervention Strategies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Drinking focused on measuring Adolescent, Alcohol, Marijuana, Mindfulness

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Research Behavioral Intervention Strategies, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Services as usual

Arm Description

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.

This group will receive services as usual from the Department of Youth Services.

Outcomes

Primary Outcome Measures

Change in Adolescent Use of Cigarettes and E-Cigarettes
Decrease in nicotine use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of Alcohol
Decrease in alcohol use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of Marijuana
Decrease in marijuana use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of Other Recreational Substances
Decrease in substance use as measured by the Youth Substance Use Interview
Change in Emotion Regulation
Increased awareness of and control over emotions as measured by the Difficulties in Emotion Regulation Questionnaire
Change in Mindfulness Behavior
Increase in Mindfulness Behavior as measured by the Five Facet Mindfulness Questionnaire
Change in Attitude toward Substance Use
Increased awareness of normative beliefs and consequences related to drug use as measured by the Adolescent Attitudes Questionnaire

Secondary Outcome Measures

Evaluate efficacy and feasibility of Rewire app in Substance Use Cessation among High-Risk Adolescents
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.

Full Information

First Posted
July 17, 2019
Last Updated
May 15, 2023
Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04027075
Brief Title
Mindfulness Mobile App to Reduce Adolescent Substance Use
Acronym
Rewire
Official Title
Mindfulness Mobile App to Reduce Adolescent Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Drinking, Adolescent Problem Behavior
Keywords
Adolescent, Alcohol, Marijuana, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will recruit 400 adolescents to test an app designed to increase mindfulness skills and reduce substance use. Participants will be randomly assigned in equal numbers to the intervention group (and will use the app) or the control group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Services as usual
Arm Type
No Intervention
Arm Description
This group will receive services as usual from the Department of Youth Services.
Intervention Type
Behavioral
Intervention Name(s)
Rewire app users
Intervention Description
Use of the Rewire app involves completing 12 modules and 12 practice sessions over 30 days.
Primary Outcome Measure Information:
Title
Change in Adolescent Use of Cigarettes and E-Cigarettes
Description
Decrease in nicotine use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview
Time Frame
Baseline, 1 month (treatment completion), 3 months
Title
Change in Adolescent Use of Alcohol
Description
Decrease in alcohol use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview
Time Frame
Baseline, 1 month (treatment completion), 3 months
Title
Change in Adolescent Use of Marijuana
Description
Decrease in marijuana use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview
Time Frame
Baseline, 1 month (treatment completion), 3 months
Title
Change in Adolescent Use of Other Recreational Substances
Description
Decrease in substance use as measured by the Youth Substance Use Interview
Time Frame
Baseline, 1 month (treatment completion), 3 months
Title
Change in Emotion Regulation
Description
Increased awareness of and control over emotions as measured by the Difficulties in Emotion Regulation Questionnaire
Time Frame
Baseline, 1 month (treatment completion), 3 months
Title
Change in Mindfulness Behavior
Description
Increase in Mindfulness Behavior as measured by the Five Facet Mindfulness Questionnaire
Time Frame
Baseline, 1 month (treatment completion), 3 months
Title
Change in Attitude toward Substance Use
Description
Increased awareness of normative beliefs and consequences related to drug use as measured by the Adolescent Attitudes Questionnaire
Time Frame
Baseline, 1 month (treatment completion), 3 months
Secondary Outcome Measure Information:
Title
Evaluate efficacy and feasibility of Rewire app in Substance Use Cessation among High-Risk Adolescents
Description
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.
Time Frame
1 month (treatment completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Smith, PhD
Organizational Affiliation
Oregon Research Behavioral Intervention Strategies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Behavioral Intervention Strategies, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

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Mindfulness Mobile App to Reduce Adolescent Substance Use

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