Mindfulness Mobile App to Reduce Adolescent Substance Use

NCT04027075 | Completed Results DMC

• 1 other identifier: DA043288-02
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Drinking; Adolescent Problem Behavior

Keywords

Adolescent; Alcohol; Marijuana; Mindfulness

Outcome Measures

Primary Outcomes (16)

• 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 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

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Services as usual

NO INTERVENTION

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

Interventions

Qlarity app users BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• non-English speaking

Sponsors & Collaborators

• Oregon Research Behavioral Intervention Strategies, Inc.: lead

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477, United States

Location

MeSH Terms

Conditions

Underage Drinking; Marijuana Abuse

Condition Hierarchy (Ancestors)

Adolescent Behavior; Behavior; Alcohol Drinking; Drinking Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dana Smith
• Organization: Oregon Research Behavioral Intervention Strategies, Inc.

dana.smith@influentsin.com

541-484-2123

Study Officials

• Dana Smith, PhD

  Oregon Research Behavioral Intervention Strategies

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: February 10, 2020
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Locations

US (1)