Mindfulness Mobile App to Reduce Adolescent Substance Use (Qlarity)

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Problem Behavior; Adolescent Drinking
• Intervention / Treatment: Behavioral: Qlarity app users

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.

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Oregon Research Behavioral Intervention Strategies, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Services as usual; This group will receive services as usual from the Department of Youth Services.
Experimental: 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.	Behavioral: Qlarity app users; Use of the Qlarity app involves completing 12 modules and 12 practice sessions over 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Adolescent Use of Cigarettes	Change in nicotine use (frequency of use and amount consumed) as measured by Youth Substance Use Interview	Baseline, 1 month, 3 months
Change in Adolescent Use of Alcohol	Change in alcohol use (frequency of use and amount consumed) as measured by Youth Substance Use Interview	Baseline, 1 month, 3 months
Change in Adolescent Use of Marijuana	Change in marijuana use (frequency of use and amount consumed) as measured by Youth Substance Use Interview	Baseline, 1 month, 3 months
Change in Adolescent Use of Other Recreational Substances	Change in use of hard drugs as measured by the Youth Substance Use Interview	Baseline, 1 month, 3 months
Number of Participants With Marijuana Use	An EZ Split Key 10 panel cup was used to detect marijuana in a urine sample.	Baseline, 3 months
Number of Participants With Prescribed Drugs Use	An EZ Split Key 10 panel cup was used to detect prescribed drugs in a urine sample.	Baseline, 3 months
Number of Participants With Hard Drug Use	An EZ Split Key 10 panel cup was used to detect hard drugs in a urine sample.	Baseline, 3 months
Change in Ability to Limit Substance Use	Self-efficacy for limiting substance use consists of 6 items that assess the ability to abstain from drug use. Response options range from 0 = cannot do at all to 10 = certainly can do. A sum score was computed and thus, values can range between 0 and 60. Higher scores indicate greater ability to abstain	Baseline, 1 month, 3 months
Change in Emotion Regulation	Emotion Regulation is measured by the Difficulties in Emotion Regulation Scale. Emotional regulation was assessed with a 5-point response option (1 = almost never, 5 = almost always). A sum score was computed and thus, values can range between 1 and 55. A higher score indicates greater levels of emotional regulation.	Baseline, 1 month, 3 months
Change in Mindfulness Behavior - Observing Subscale	Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.	Baseline, 1 month, 3 months
Change in Mindfulness Behavior - Describing Subscale	Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.	Baseline, 1 month, 3 months
Change in Mindfulness Behavior - Acting With Awareness Subscale	Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.	Baseline, 1 month, 2 months
Change in Mindfulness Behavior - Non-judging of Inner Experience Subscale	Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.	Baseline, 1 month, 3 months
Change in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale	Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.	Baseline, 1 month, 3 months
Change in Attitude Toward Substance Use - Beliefs and Consequences Subscale	Change in attitude related to drug use is measured with Adolescent Attitudes toward Substance Use. Subscales are (1) Beliefs and Consequences (9 items) and (2) Lifestyle and Value incompatibility (5 items). Response options were 0 to 10. Standardized scores were computed and values could range from -2.0 to 2.0. Higher scores represent more prosocial attitudes.	Baseline, 1 month, 3 months
Change in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale	Change in attitude related to drug use is measured with Adolescent Attitudes toward Substance Use. Subscales are (1) Beliefs and Consequences (9 items) and (2) Lifestyle and Value incompatibility (5 items). Response options were 0 to 10. Standardized scores were computed and values could range from -2.0 to 2.0. Higher scores represent more prosocial attitudes.	Baseline, 1 month, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
• Investigators: Principal Investigator: Dana Smith, PhD, Oregon Research Behavioral Intervention Strategies

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Adolescent; Mindfulness; Alcohol; Marijuana
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Chemically-Induced Disorders; Drinking Behavior; Alcohol Drinking; Problem Behavior; Underage Drinking; Substance-Related Disorders
• Other Study ID Numbers: DA043288-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No