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Mindfulness Mobile App to Reduce Adolescent Substance Use (Qlarity)

O

Oregon Research Behavioral Intervention Strategies

Status

Completed

Conditions

Adolescent Drinking
Adolescent Problem Behavior

Treatments

Behavioral: Qlarity app users

Study type

Interventional

Funder types

Industry

Identifiers

NCT04027075
DA043288-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

277 patients

Sex

All

Ages

13 to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

277 participants in 2 patient groups

Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Qlarity app users
Services as usual
No Intervention group
Description:
This group will receive services as usual from the Department of Youth Services.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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