Clinical trial NCT04027075: Mindfulness Mobile App to Reduce Adolescent Substance Use
Official title: Mindfulness Mobile App to Reduce Adolescent Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Drinking
Adolescent Problem Behavior
Keywords: Adolescent
Alcohol
Marijuana
Mindfulness
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-19
Enrollment: 257
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will recruit 400 adolescents to test an app designed to increase mindfulness skills and reduce substance use. Participants will be randomly assigned in equal numbers to the intervention group (and will use the app) or the control group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Marijuana Use
timeFrame: Baseline, 3 months
measure: Number of Participants With Prescribed Drugs Use
timeFrame: Baseline, 3 months
measure: Number of Participants With Hard Drug Use
timeFrame: Baseline, 3 months
measure: Change in Adolescent Use of Cigarettes
timeFrame: Baseline, 1 month, 3 months
measure: Change in Adolescent Use of Alcohol
timeFrame: Baseline, 1 month, 3 months
measure: Change in Adolescent Use of Marijuana
timeFrame: Baseline, 1 month, 3 months
measure: Change in Adolescent Use of Other Recreational Substances
timeFrame: Baseline, 1 month, 3 months
measure: Change in Ability to Limit Substance Use
timeFrame: Baseline, 1 month, 3 months
measure: Change in Emotion Regulation
timeFrame: Baseline, 1 month, 3 months
measure: Change in Mindfulness Behavior - Observing Subscale
timeFrame: Baseline, 1 month, 3 months
measure: Change in Mindfulness Behavior - Describing Subscale
timeFrame: Baseline, 1 month, 3 months
measure: Change in Mindfulness Behavior - Acting With Awareness Subscale
timeFrame: Baseline, 1 month, 2 months
measure: Change in Mindfulness Behavior - Non-judging of Inner Experience Subscale
timeFrame: Baseline, 1 month, 3 months
measure: Change in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale
timeFrame: Baseline, 1 month, 3 months
measure: Change in Attitude Toward Substance Use - Beliefs and Consequences Subscale
timeFrame: Baseline, 1 month, 3 months
measure: Change in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Oregon Research Behavioral Intervention Strategies, Inc.
state: Oregon
Study officials:
affiliation: Oregon Research Behavioral Intervention Strategies
name: Dana Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: