The Rewire Study (Mindfulness Mobile App to Reduce Adolescent Substance Use)

Mindfulness Mobile App to Reduce Adolescent Substance Use

The current proposal is aimed at developing a substance use cessation app (Rewire) for high risk adolescents who are involved in the juvenile justice system. The Rewire app will be 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.

Study Overview

• Status: Completed
• Conditions: Adolescent Substance Use
• Intervention / Treatment: Behavioral: Rewire App

Detailed Description

The Rewire Study will recruit 60 youth (30 boys and 30 girls) who have had contact with the Department of Youth Services in the last year. Consent will be obtained from parents or guardians for the youths' participation. The participating teens will come to Oregon Research Institute for a baseline assessment. During this visit, the teens will complete an assent form and spend 20-30 minutes completing an online survey with an assessor; topics covered in the survey include emotion regulation and drug and alcohol use. Teens will have the app loaded onto their phones and be provided with instructions for its use during this visit. Participants are asked to use the app over the next 2 weeks, completing 4 modules and spending 5-10 minutes each day answering questions about recent emotions and substance use. Teens will be contacted via email for follow up assessments at 8 weeks post-baseline. These emails will contain links to the follow-up surveys which also ask about emotion regulation and drug and alcohol use; surveys should take 20-30 minutes to complete.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • Oregon Research Behavioral Intervention Strategies, Inc./Oregon Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ages 13 to 18
• involved with Juvenile Justice system
• documented substance use
• English-speaking
• living in the community

Exclusion Criteria:

• non English-speaking
• living in treatment or detention facility

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App Evaluation; All 60 teens in The Rewire Study will complete the first 4 modules of the Rewire app. Prior to using the app, they will complete a baseline assessment. Follow up surveys will be completed at 2 weeks and 8 weeks post-baseline.	Behavioral: Rewire App; A prototype Rewire app will be designed and created; the first four modules will be evaluated by 60 high-risk adolescents. The teens are asked to complete each module and spend a few minutes each day for two weeks using the practice exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adolescent Use of Cigarettes	Proportion of participants that use cigarettes as measured by Youth Substances Interview	Baseline (pretest), 8 weeks (posttest)
Adolescent Use of E-cigarettes	Proportion of participants that use e-cigarette use as measured by Youth Substances Interview	Baseline (pretest), 8 weeks (posttest)
Adolescent Use of Alcohol	Proportion of participants that use alcohol use as measured by Youth Substances Interview	Baseline (pretest), 8 weeks (posttest)
Adolescent Use of Marijuana	Proportion of participants that use marijuana use as measured by Youth Substances Interview	Baseline (pretest), 8 weeks (posttest)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Adolescent Mindfulness Practices - Observe Subscale	Mindfulness is measured using the Five Facet Mindfulness Questionnaire. Mindfulness (Baer et al. 2006) was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and mean scores were computed for each subscale. A higher score indicates greater levels of mindfulness. 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).	Baseline (pretest), 8 weeks (posttest)
Changes in Adolescent Mindfulness Practices - Describing Subscale	Mindfulness is measured using the Five Facet Mindfulness Questionnaire. Mindfulness (Baer et al. 2006) was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and mean scores were computed for each subscale. A higher score indicates greater levels of mindfulness. 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).	Baseline (pretest) and 8-weeks (posttest)
Change in Adolescent Mindfulness Practices - Acting With Awareness Subscale	Mindfulness is measured using the Five Facet Mindfulness Questionnaire. Mindfulness (Baer et al. 2006) was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and mean scores were computed for each subscale. A higher score indicates greater levels of mindfulness. 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).	Baseline (pretest) and 8-week (posttest)
Change in Adolescent Mindfulness Practices - Non-judging of Inner Experiences Subscale	Mindfulness is measured using the Five Facet Mindfulness Questionnaire. Mindfulness (Baer et al. 2006) was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and mean scores were computed for each subscale. A higher score indicates greater levels of mindfulness. 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).	Baseline (pretest) and 8-weeks (posttest)
Change in Adolescent Mindfulness Practices - Non-reactivity to Inner Experience Subscale	Mindfulness is measured using the Five Facet Mindfulness Questionnaire. Mindfulness (Baer et al. 2006) was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and mean scores were computed for each subscale. A higher score indicates greater levels of mindfulness. 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).	Baseline (pretest) and 8-week (posttest)
Changes in Emotion Regulation - Non-acceptance of Emotional Response Subscale	Emotion Regulation is measured with the Difficulties in Emotion Regulation Scale. Emotional regulation (Gratz and Roemer, 2004) was assessed with a 5-point response option (1 = almost never, 5 = almost always) and mean scores were computed for each subscale. A higher score indicates greater levels of emotional regulation. Subscales include non-acceptance of emotional response (6 items), difficulties engaging in goals (5 items), impulse control difficulties (6 items), lack of emotional awareness (6 items), limited access to emotion regulation strategies (8 items), and lack of emotional clarity (6 items).	Baseline (pretest), 8 weeks (posttest)
Changes in Emotional Regulation - Difficulties Engaging in Goals Subscale	Emotion Regulation is measured with the Difficulties in Emotion Regulation Scale. Emotional regulation (Gratz and Roemer, 2004) was assessed with a 5-point response option (1 = almost never, 5 = almost always) and mean scores were computed for each subscale. A higher score indicates greater levels of emotional regulation. Subscales include non-acceptance of emotional response (6 items), difficulties engaging in goals (5 items), impulse control difficulties (6 items), lack of emotional awareness (6 items), limited access to emotion regulation strategies (8 items), and lack of emotional clarity (6 items).	Baseline (pretest) and 8-weeks (posttest)
Changes in Emotional Regulation - Impulse Control Difficulties Subscale	Emotion Regulation is measured with the Difficulties in Emotion Regulation Scale. Emotional regulation (Gratz and Roemer, 2004) was assessed with a 5-point response option (1 = almost never, 5 = almost always) and mean scores were computed for each subscale. A higher score indicates greater levels of emotional regulation. Subscales include non-acceptance of emotional response (6 items), difficulties engaging in goals (5 items), impulse control difficulties (6 items), lack of emotional awareness (6 items), limited access to emotion regulation strategies (8 items), and lack of emotional clarity (6 items).	Baseline (pretest) and 8-weeks (posttest)
Changes in Emotional Regulation - Lack of Emotional Awareness Subscale	Emotion Regulation is measured with the Difficulties in Emotion Regulation Scale. Emotional regulation (Gratz and Roemer, 2004) was assessed with a 5-point response option (1 = almost never, 5 = almost always) and mean scores were computed for each subscale. A higher score indicates greater levels of emotional regulation. Subscales include non-acceptance of emotional response (6 items), difficulties engaging in goals (5 items), impulse control difficulties (6 items), lack of emotional awareness (6 items), limited access to emotion regulation strategies (8 items), and lack of emotional clarity (6 items).	Baseline (pretest) and 8-weeks (Posttest)
Changes in Emotional Regulation - Limited Access to Emotion Regulation Strategies Subscale	Emotion Regulation is measured with the Difficulties in Emotion Regulation Scale. Emotional regulation (Gratz and Roemer, 2004) was assessed with a 5-point response option (1 = almost never, 5 = almost always) and mean scores were computed for each subscale. A higher score indicates greater levels of emotional regulation. Subscales include non-acceptance of emotional response (6 items), difficulties engaging in goals (5 items), impulse control difficulties (6 items), lack of emotional awareness (6 items), limited access to emotion regulation strategies (8 items), and lack of emotional clarity (6 items).	Baseline (pretest) and 8-week (posttest)
Changes in Emotional Regulation - Lack of Emotional Clarity	Emotion Regulation is measured with the Difficulties in Emotion Regulation Scale. Emotional regulation (Gratz and Roemer, 2004) was assessed with a 5-point response option (1 = almost never, 5 = almost always) and mean scores were computed for each subscale. A higher score indicates greater levels of emotional regulation. Subscales include non-acceptance of emotional response (6 items), difficulties engaging in goals (5 items), impulse control difficulties (6 items), lack of emotional awareness (6 items), limited access to emotion regulation strategies (8 items), and lack of emotional clarity (6 items).	Baseline (pretest) and 8-weeks (posttest)

Collaborators and Investigators

• Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Dana K Smith, Ph.D., Oregon Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 13, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: DA043288-01; 1R43DA043288-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No