Clinical trial NCT03533491: The Rewire Study (Mindfulness Mobile App to Reduce Adolescent Substance Use)
Official title: Mindfulness Mobile App to Reduce Adolescent Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Substance Use
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All 60 teens in The Rewire Study will complete the first 4 modules of the Rewire app.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adolescent Use of Cigarettes
timeFrame: Baseline (pretest), 8 weeks (posttest)
measure: Adolescent Use of E-cigarettes
timeFrame: Baseline (pretest), 8 weeks (posttest)
measure: Adolescent Use of Alcohol
timeFrame: Baseline (pretest), 8 weeks (posttest)
measure: Adolescent Use of Marijuana
timeFrame: Baseline (pretest), 8 weeks (posttest)
Secondary outcomes:
measure: Changes in Adolescent Mindfulness Practices - Observe Subscale
timeFrame: Baseline (pretest), 8 weeks (posttest)
measure: Changes in Adolescent Mindfulness Practices - Describing Subscale
timeFrame: Baseline (pretest) and 8-weeks (posttest)
measure: Change in Adolescent Mindfulness Practices - Acting With Awareness Subscale
timeFrame: Baseline (pretest) and 8-week (posttest)
measure: Change in Adolescent Mindfulness Practices - Non-judging of Inner Experiences Subscale
timeFrame: Baseline (pretest) and 8-weeks (posttest)
measure: Change in Adolescent Mindfulness Practices - Non-reactivity to Inner Experience Subscale
timeFrame: Baseline (pretest) and 8-week (posttest)
measure: Changes in Emotion Regulation - Non-acceptance of Emotional Response Subscale
timeFrame: Baseline (pretest), 8 weeks (posttest)
measure: Changes in Emotional Regulation - Difficulties Engaging in Goals Subscale
timeFrame: Baseline (pretest) and 8-weeks (posttest)
measure: Changes in Emotional Regulation - Impulse Control Difficulties Subscale
timeFrame: Baseline (pretest) and 8-weeks (posttest)
measure: Changes in Emotional Regulation - Lack of Emotional Awareness Subscale
timeFrame: Baseline (pretest) and 8-weeks (Posttest)
measure: Changes in Emotional Regulation - Limited Access to Emotion Regulation Strategies Subscale
timeFrame: Baseline (pretest) and 8-week (posttest)
measure: Changes in Emotional Regulation - Lack of Emotional Clarity
timeFrame: Baseline (pretest) and 8-weeks (posttest)
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Behavioral Intervention Strategies, Inc./Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Dana K Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: