Mindfulness Mobile App to Reduce Adolescent Substance Use

Adolescent Problem Behavior Clinical Trial

— Rewire II  

Official title:

Mindfulness Mobile App to Reduce Adolescent Substance Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027075
• Other study ID #: DA043288-02
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2024
• Source: Oregon Research Behavioral Intervention Strategies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Drinking
• Adolescent Problem Behavior
• Problem Behavior
• Substance-Related Disorders
• Underage Drinking

Intervention

Behavioral:
• Rewire app users
Use of the Rewire app involves completing 12 modules and 12 practice sessions over 30 days.

Locations

Country	Name	City	State
United States	Oregon Research Behavioral Intervention Strategies, Inc.	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Behavioral Intervention Strategies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 1 month (treatment completion), 3 months
Primary	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	Baseline, 1 month (treatment completion), 3 months
Primary	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	Baseline, 1 month (treatment completion), 3 months
Primary	Change in Adolescent Use of Other Recreational Substances	Decrease in substance use as measured by the Youth Substance Use Interview	Baseline, 1 month (treatment completion), 3 months
Primary	Change in Emotion Regulation	Increased awareness of and control over emotions as measured by the Difficulties in Emotion Regulation Questionnaire	Baseline, 1 month (treatment completion), 3 months
Primary	Change in Mindfulness Behavior	Increase in Mindfulness Behavior as measured by the Five Facet Mindfulness Questionnaire	Baseline, 1 month (treatment completion), 3 months
Primary	Change in Attitude toward Substance Use	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	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.	1 month (treatment completion)