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
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Drinking Adolescent Problem Behavior||Behavioral: Rewire app users||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|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)|
|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|
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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
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
|Contact: Dana Smith, PhD||541-484-2123 ext firstname.lastname@example.org|
|Contact: David R Smith, PhD, PMP||541-484-2123 ext 2966||David.Smith@influentsin.com|
|United States, Oregon|
|Oregon Research Behavioral Intervention Strategies, Inc.|
|Eugene, Oregon, United States, 97403|