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Completed

NCT Number: NCT04027075

Mindfulness Mobile App to Reduce Adolescent Substance Use

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.

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Key information

Conditions

Adolescent Drinking Adolescent Behavior Adolescent Problem Behavior Alcohol Drinking Behavior Chemically-Induced Disorders Drinking Behavior Marijuana Abuse Mental Disorders Substance-Related Disorders Underage Drinking

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qlarity app users

Behavioral

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

Primary outcomes

  1. Number of Participants With Marijuana Use

    Time frame: Baseline, 3 months

    An EZ Split Key 10 panel cup was used to detect marijuana in a urine sample.

  2. Number of Participants With Prescribed Drugs Use

    Time frame: Baseline, 3 months

    An EZ Split Key 10 panel cup was used to detect prescribed drugs in a urine sample.

  3. Number of Participants With Hard Drug Use

    Time frame: Baseline, 3 months

    An EZ Split Key 10 panel cup was used to detect hard drugs in a urine sample.

  4. Change in Adolescent Use of Cigarettes

    Time frame: Baseline, 1 month, 3 months

    Change in nicotine use (frequency of use and amount consumed) as measured by Youth Substance Use Interview

  5. Change in Adolescent Use of Alcohol

    Time frame: Baseline, 1 month, 3 months

    Change in alcohol use (frequency of use and amount consumed) as measured by Youth Substance Use Interview

  6. Change in Adolescent Use of Marijuana

    Time frame: Baseline, 1 month, 3 months

    Change in marijuana use (frequency of use and amount consumed) as measured by Youth Substance Use Interview

  7. Change in Adolescent Use of Other Recreational Substances

    Time frame: Baseline, 1 month, 3 months

    Change in use of hard drugs as measured by the Youth Substance Use Interview

  8. Change in Ability to Limit Substance Use

    Time frame: Baseline, 1 month, 3 months

    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

  9. Change in Emotion Regulation

    Time frame: Baseline, 1 month, 3 months

    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.

  10. Change in Mindfulness Behavior - Observing Subscale

    Time frame: Baseline, 1 month, 3 months

    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.

  11. Change in Mindfulness Behavior - Describing Subscale

    Time frame: Baseline, 1 month, 3 months

    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.

  12. Change in Mindfulness Behavior - Acting With Awareness Subscale

    Time frame: Baseline, 1 month, 2 months

    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.

  13. Change in Mindfulness Behavior - Non-judging of Inner Experience Subscale

    Time frame: Baseline, 1 month, 3 months

    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.

  14. Change in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale

    Time frame: Baseline, 1 month, 3 months

    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.

  15. Change in Attitude Toward Substance Use - Beliefs and Consequences Subscale

    Time frame: Baseline, 1 month, 3 months

    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.

  16. Change in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale

    Time frame: Baseline, 1 month, 3 months

    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.

Sponsors and collaborators

Lead sponsor

Oregon Research Behavioral Intervention Strategies, Inc.

Industry

Registry information

Acronym: Qlarity

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2019
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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