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Mindfulness Mobile App to Reduce Adolescent Substance Use (Rewire)

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ClinicalTrials.gov Identifier: NCT04027075
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Oregon Research Behavioral Intervention Strategies, Inc.

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 Rewire, that is geared toward helping high risk adolescent substance users reduce or quit their substance use. The Rewire 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.

Condition or disease Intervention/treatment Phase
Adolescent Drinking Adolescent Problem Behavior Behavioral: Rewire app users Not Applicable

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. Rewire 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 Rewire app will be evaluated with 380 high risk adolescents that are involved in the juvenile justice system; participants will be randomly and equally assigned to the Rewire 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 Rewire group will receive instructions for using the app in the 28 days following baseline. All youth will complete 1 and 3 month followups. Assessments will consist of online surveys asking about substance use, emotion regulation, family demographics, and mindfulness practices. The Rewire 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will recruit 380 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Mobile App to Reduce Adolescent Substance Use
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Arm Intervention/treatment
Experimental: Intervention
This group will be asked to use the Rewire app daily in the month following the baseline assessment. This group will also receive services as usual from the Department of Youth Services.
Behavioral: Rewire app users
Use of the Rewire app involves completing 12 modules and 12 practice sessions over 30 days.

No Intervention: Services as usual
This group will receive services as usual from the Department of Youth Services.



Primary Outcome Measures :
  1. Change in Adolescent Use of Cigarettes and E-Cigarettes [ Time Frame: Baseline, 1 month (treatment completion), 3 months ]
    Decrease in nicotine use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview

  2. Change in Adolescent Use of Alcohol [ Time Frame: Baseline, 1 month (treatment completion), 3 months ]
    Decrease in alcohol use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview

  3. Change in Adolescent Use of Marijuana [ Time Frame: Baseline, 1 month (treatment completion), 3 months ]
    Decrease in marijuana use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview

  4. Change in Adolescent Use of Other Recreational Substances [ Time Frame: Baseline, 1 month (treatment completion), 3 months ]
    Decrease in substance use as measured by the Youth Substance Use Interview

  5. Change in Emotion Regulation [ Time Frame: Baseline, 1 month (treatment completion), 3 months ]
    Increased awareness of and control over emotions as measured by the Difficulties in Emotion Regulation Questionnaire

  6. Change in Mindfulness Behavior [ Time Frame: Baseline, 1 month (treatment completion), 3 months ]
    Increase in Mindfulness Behavior as measured by the Five Facet Mindfulness Questionnaire

  7. Change in Attitude toward Substance Use [ Time Frame: Baseline, 1 month (treatment completion), 3 months ]
    Increased awareness of normative beliefs and consequences related to drug use as measured by the Adolescent Attitudes Questionnaire


Secondary Outcome Measures :
  1. Evaluate efficacy and feasibility of Rewire app in Substance Use Cessation among High-Risk Adolescents [ Time Frame: 1 month (treatment completion) ]
    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.



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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027075


Contacts
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Contact: Dana Smith, PhD 541-484-2123 ext 2305 danas@ori.org
Contact: David R Smith, PhD, PMP 541-484-2123 ext 2966 David.Smith@influentsin.com

Locations
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United States, Oregon
Oregon Research Behavioral Intervention Strategies, Inc.
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Behavioral Intervention Strategies, Inc.

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Responsible Party: Oregon Research Behavioral Intervention Strategies, Inc.
ClinicalTrials.gov Identifier: NCT04027075     History of Changes
Other Study ID Numbers: DA043288
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oregon Research Behavioral Intervention Strategies, Inc.:
Adolescent
Alcohol
Marijuana
Mindfulness

Additional relevant MeSH terms:
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Problem Behavior
Underage Drinking
Behavioral Symptoms
Alcohol Drinking
Drinking Behavior