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

NCT ID: NCT03533491

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-30
• Study Completion Date: 2018-10-31

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 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 8 weeks post-baseline. These emails will contain links to the follow-up surveys which also ask about emotion regulation and drug and alcohol use; surveys should take 20-30 minutes to complete.

Conditions

Adolescent Substance Use

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Rewire App

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ages 13 to 18
• 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Oregon Research Behavioral Intervention Strategies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana K Smith, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Institute

Locations

Oregon Research Behavioral Intervention Strategies, Inc./Oregon Research Institute

Eugene, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R43DA043288-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DA043288-01

Identifier Type: -

Identifier Source: org_study_id