NCT03533491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
6 years until next milestone

Results Posted

Study results publicly available

November 13, 2024

Completed
Last Updated

November 13, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

April 17, 2018

Results QC Date

August 19, 2024

Last Update Submit

October 18, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (11)

  • Changes in Adolescent Mindfulness Practices - Observe Subscale

    Baseline (pretest), 8 weeks (posttest)

  • Changes in Adolescent Mindfulness Practices - Describing Subscale

    Baseline (pretest) and 8-weeks (posttest)

  • Change in Adolescent Mindfulness Practices - Acting With Awareness Subscale

    Baseline (pretest) and 8-week (posttest)

  • Change in Adolescent Mindfulness Practices - Non-judging of Inner Experiences Subscale

    Baseline (pretest) and 8-weeks (posttest)

  • Change in Adolescent Mindfulness Practices - Non-reactivity to Inner Experience Subscale

    Baseline (pretest) and 8-week (posttest)

  • +6 more secondary outcomes

Study Arms (1)

App Evaluation

EXPERIMENTAL

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

Interventions

Rewire AppBEHAVIORAL

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.

App Evaluation

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc./Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Results Point of Contact

Title
Dana Smith
Organization
Oregon Research Behavioral Intervention Strategies, Inc.

Study Officials

  • Dana K Smith, Ph.D.

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All 60 teens in The Rewire Study will complete the first 4 modules of the Rewire app.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 23, 2018

Study Start

March 30, 2018

Primary Completion

August 30, 2018

Study Completion

October 31, 2018

Last Updated

November 13, 2024

Results First Posted

November 13, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations