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

Mindfulness Mobile App to Reduce Adolescent Substance Use

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Substance Use
• Intervention / Treatment: Behavioral: Rewire App

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • ORBIS/Oregon Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App Evaluation; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
• Investigators: Principal Investigator: Dana K Smith, Ph.D., Oregon Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: DA043288-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No