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

Primary Purpose

Adolescent Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rewire App
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 Substance Use

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ORBIS/Oregon Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

App Evaluation

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Evaluate first 4 modules of prototype app
Participant satisfaction ratings are collected through interview questions

Full Information

First Posted
April 17, 2018
Last Updated
March 12, 2019
Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03533491
Brief Title
The Rewire Study (Mindfulness Mobile App to Reduce Adolescent Substance Use)
Official Title
Mindfulness Mobile App to Reduce Adolescent Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
October 31, 2018 (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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Substance Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
App Evaluation
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Rewire App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Adolescent Attitudes toward Substance Use
Description
Adolescent Attitudes toward Substance Use measures beliefs about social norms and consequences. Higher scores represent more prosocial attitudes.
Time Frame
Baseline, 2 weeks, 8 weeks
Secondary Outcome Measure Information:
Title
Changes in Adolescent Mindfulness Practices
Description
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.
Time Frame
Baseline, 2 weeks, 8 weeks
Title
Changes in Emotion Regulation
Description
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.
Time Frame
Baseline, 2 weeks, 8 weeks
Title
Evaluate first 4 modules of prototype app
Description
Participant satisfaction ratings are collected through interview questions
Time Frame
Intervention period (time of app use) is from Baseline to 2 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana K Smith, Ph.D.
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
ORBIS/Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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