Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 18 of 21 for:    E-cigarettes youth

Mindfulness Mobile App to Reduce Adolescent Substance Use (Rewire)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 19, 2019
Estimated Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Mobile App to Reduce Adolescent Substance Use
Official Title  ICMJE Mindfulness Mobile App to Reduce Adolescent Substance Use
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Adolescent Drinking
  • Adolescent Problem Behavior
Intervention  ICMJE Behavioral: Rewire app users
Use of the Rewire app involves completing 12 modules and 12 practice sessions over 30 days.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Rewire app users
  • No Intervention: Services as usual
    This group will receive services as usual from the Department of Youth Services.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)
380
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027075
Other Study ID Numbers  ICMJE DA043288
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oregon Research Behavioral Intervention Strategies, Inc.
Study Sponsor  ICMJE Oregon Research Behavioral Intervention Strategies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oregon Research Behavioral Intervention Strategies, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP