Skip to content

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

Mindfulness Mobile App to Reduce Adolescent Substance Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03533491
Enrollment
60
Registered
2018-05-23
Start date
2018-03-30
Completion date
2018-10-31
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Substance Use

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.

Interventions

BEHAVIORALRewire 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Oregon Research Behavioral Intervention Strategies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

All 60 teens in The Rewire Study will complete the first 4 modules of the Rewire app.

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adolescent Use of CigarettesBaseline (pretest), 8 weeks (posttest)Proportion of participants that use cigarettes as measured by Youth Substances Interview
Adolescent Use of E-cigarettesBaseline (pretest), 8 weeks (posttest)Proportion of participants that use e-cigarette use as measured by Youth Substances Interview
Adolescent Use of AlcoholBaseline (pretest), 8 weeks (posttest)Proportion of participants that use alcohol use as measured by Youth Substances Interview
Adolescent Use of MarijuanaBaseline (pretest), 8 weeks (posttest)Proportion of participants that use marijuana use as measured by Youth Substances Interview

Secondary

MeasureTime frameDescription
Change in Adolescent Mindfulness Practices - Non-reactivity to Inner Experience SubscaleBaseline (pretest) and 8-week (posttest)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).
Changes in Emotion Regulation - Non-acceptance of Emotional Response SubscaleBaseline (pretest), 8 weeks (posttest)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).
Changes in Emotional Regulation - Difficulties Engaging in Goals SubscaleBaseline (pretest) and 8-weeks (posttest)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).
Changes in Adolescent Mindfulness Practices - Observe SubscaleBaseline (pretest), 8 weeks (posttest)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).
Changes in Emotional Regulation - Lack of Emotional Awareness SubscaleBaseline (pretest) and 8-weeks (Posttest)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).
Changes in Emotional Regulation - Limited Access to Emotion Regulation Strategies SubscaleBaseline (pretest) and 8-week (posttest)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).
Changes in Emotional Regulation - Lack of Emotional ClarityBaseline (pretest) and 8-weeks (posttest)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).
Changes in Emotional Regulation - Impulse Control Difficulties SubscaleBaseline (pretest) and 8-weeks (posttest)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).
Changes in Adolescent Mindfulness Practices - Describing SubscaleBaseline (pretest) and 8-weeks (posttest)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).
Change in Adolescent Mindfulness Practices - Acting With Awareness SubscaleBaseline (pretest) and 8-week (posttest)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).
Change in Adolescent Mindfulness Practices - Non-judging of Inner Experiences SubscaleBaseline (pretest) and 8-weeks (posttest)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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
60
Total60

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up2

Baseline characteristics

CharacteristicApp Evaluation
Age, Continuous15.57 years
STANDARD_DEVIATION 1.42
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
13 Participants
Race (NIH/OMB)
White
38 Participants
Sex: Female, Male
Female
30 Participants
Sex: Female, Male
Male
30 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 60
other
Total, other adverse events
0 / 60
serious
Total, serious adverse events
0 / 60

Outcome results

Primary

Adolescent Use of Alcohol

Proportion of participants that use alcohol use as measured by Youth Substances Interview

Time frame: Baseline (pretest), 8 weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationAdolescent Use of AlcoholPretest0.39 proportion of participantsStandard Deviation 0.49
App EvaluationAdolescent Use of AlcoholPosttest0.44 proportion of participantsStandard Deviation 0.5
p-value: 0.37t-test, 2 sided
Primary

Adolescent Use of Cigarettes

Proportion of participants that use cigarettes as measured by Youth Substances Interview

Time frame: Baseline (pretest), 8 weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationAdolescent Use of CigarettesPretest0.19 proportion of participantsStandard Deviation 0.4
App EvaluationAdolescent Use of CigarettesPosttest0.12 proportion of participantsStandard Deviation 0.33
p-value: 0.044t-test, 2 sided
Primary

Adolescent Use of E-cigarettes

Proportion of participants that use e-cigarette use as measured by Youth Substances Interview

Time frame: Baseline (pretest), 8 weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationAdolescent Use of E-cigarettesPretest0.32 proportion of participantsStandard Deviation 0.47
App EvaluationAdolescent Use of E-cigarettesPosttest0.28 proportion of participantsStandard Deviation 0.45
p-value: 0.532t-test, 2 sided
Primary

Adolescent Use of Marijuana

Proportion of participants that use marijuana use as measured by Youth Substances Interview

Time frame: Baseline (pretest), 8 weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationAdolescent Use of MarijuanaPretest0.54 proportion of participantsStandard Deviation 0.5
App EvaluationAdolescent Use of MarijuanaPosttest0.40 proportion of participantsStandard Deviation 0.49
p-value: 0.02t-test, 2 sided
Secondary

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).

Time frame: Baseline (pretest) and 8-week (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChange in Adolescent Mindfulness Practices - Acting With Awareness SubscalePretest2.89 units on a scaleStandard Deviation 0.48
App EvaluationChange in Adolescent Mindfulness Practices - Acting With Awareness SubscalePosttest2.86 units on a scaleStandard Deviation 0.57
p-value: 0.745t-test, 2 sided
Secondary

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).

Time frame: Baseline (pretest) and 8-weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChange in Adolescent Mindfulness Practices - Non-judging of Inner Experiences SubscalePretest3.52 units on a scaleStandard Deviation 0.81
App EvaluationChange in Adolescent Mindfulness Practices - Non-judging of Inner Experiences SubscalePosttest3.37 units on a scaleStandard Deviation 0.79
p-value: 0.132t-test, 2 sided
Secondary

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).

Time frame: Baseline (pretest) and 8-week (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChange in Adolescent Mindfulness Practices - Non-reactivity to Inner Experience SubscalePretest2.97 units on a scaleStandard Error 0.65
App EvaluationChange in Adolescent Mindfulness Practices - Non-reactivity to Inner Experience SubscalePosttest2.91 units on a scaleStandard Error 0.81
p-value: 0.551t-test, 2 sided
Secondary

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).

Time frame: Baseline (pretest) and 8-weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChanges in Adolescent Mindfulness Practices - Describing SubscalePretest3.29 units on a scaleStandard Deviation 0.68
App EvaluationChanges in Adolescent Mindfulness Practices - Describing SubscalePosttest3.28 units on a scaleStandard Deviation 0.73
p-value: 0.978t-test, 2 sided
Secondary

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).

Time frame: Baseline (pretest), 8 weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChanges in Adolescent Mindfulness Practices - Observe SubscalePretest3.08 units on a scaleStandard Deviation 0.75
App EvaluationChanges in Adolescent Mindfulness Practices - Observe SubscalePosttest3.05 units on a scaleStandard Deviation 0.87
p-value: 0.773t-test, 2 sided
Secondary

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).

Time frame: Baseline (pretest) and 8-weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChanges in Emotional Regulation - Difficulties Engaging in Goals SubscalePretest2.83 units on a scaleStandard Deviation 1.02
App EvaluationChanges in Emotional Regulation - Difficulties Engaging in Goals SubscalePosttest2.69 units on a scaleStandard Deviation 1.09
Secondary

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).

Time frame: Baseline (pretest) and 8-weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChanges in Emotional Regulation - Impulse Control Difficulties SubscalePretest1.86 units on a scaleStandard Deviation 0.92
App EvaluationChanges in Emotional Regulation - Impulse Control Difficulties SubscalePosttest1.98 units on a scaleStandard Deviation 0.87
p-value: 0.198t-test, 2 sided
Secondary

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).

Time frame: Baseline (pretest) and 8-weeks (Posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChanges in Emotional Regulation - Lack of Emotional Awareness SubscalePretest2.79 units on a scaleStandard Deviation 0.87
App EvaluationChanges in Emotional Regulation - Lack of Emotional Awareness SubscalePosttest2.82 units on a scaleStandard Deviation 0.96
p-value: 0.77t-test, 2 sided
Secondary

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).

Time frame: Baseline (pretest) and 8-weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChanges in Emotional Regulation - Lack of Emotional ClarityPretest2.22 units on a scaleStandard Deviation 0.71
App EvaluationChanges in Emotional Regulation - Lack of Emotional ClarityPosttest2.31 units on a scaleStandard Deviation 0.77
p-value: 0.175t-test, 2 sided
Secondary

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).

Time frame: Baseline (pretest) and 8-week (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChanges in Emotional Regulation - Limited Access to Emotion Regulation Strategies SubscalePretest2.22 units on a scaleStandard Deviation 1.05
App EvaluationChanges in Emotional Regulation - Limited Access to Emotion Regulation Strategies SubscalePosttest2.25 units on a scaleStandard Deviation 1.03
p-value: 0.834t-test, 2 sided
Secondary

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).

Time frame: Baseline (pretest), 8 weeks (posttest)

ArmMeasureGroupValue (MEAN)Dispersion
App EvaluationChanges in Emotion Regulation - Non-acceptance of Emotional Response SubscalePretest1.93 units on a scaleStandard Deviation 0.86
App EvaluationChanges in Emotion Regulation - Non-acceptance of Emotional Response SubscalePosttest2.09 units on a scaleStandard Deviation 1.05
p-value: 0.255t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026