Mindfulness Mobile App to Reduce Adolescent Substance Use

NCT ID: NCT04027075

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-10
• Study Completion Date: 2023-04-30

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 Qlarity, that is geared toward helping high risk adolescent substance users reduce or quit their substance use. The Qlarity 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. Qlarity 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 Qlarity 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 Qlarity 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 Qlarity group will receive instructions for using the app in the 28 days following baseline. All youth will complete 1 and 3 month follow-ups. Assessments will consist of online surveys asking about substance use, emotion regulation, family demographics, and mindfulness practices. The Qlarity 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.

Conditions

Adolescent Drinking; Adolescent Problem Behavior

Keywords

Adolescent; Alcohol; Marijuana; Mindfulness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

This group will be asked to use the Qlarity app daily in the month following the baseline assessment. This group will also receive services as usual from the Department of Youth Services.

Group Type: EXPERIMENTAL

Qlarity app users

Intervention Type: BEHAVIORAL

Use of the Qlarity app involves completing 12 modules and 12 practice sessions over 30 days.

Services as usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Qlarity app users

Use of the Qlarity app involves completing 12 modules and 12 practice sessions over 30 days.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Research Behavioral Intervention Strategies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Behavioral Intervention Strategies

Locations

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, 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

DA043288-02

Identifier Type: -

Identifier Source: org_study_id