Trial Outcomes & Findings for The Rewire Study (Mindfulness Mobile App to Reduce Adolescent Substance Use) (NCT NCT03533491)

NCT ID: NCT03533491

Last Updated: 2024-11-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline (pretest), 8 weeks (posttest)
• Results posted on: 2024-11-13

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	60
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

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.

Overall Study Lost to Follow-up

2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	App Evaluation n=60 Participants 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.
Age, Continuous	15.57 years STANDARD_DEVIATION 1.42 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pretest), 8 weeks (posttest)

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

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Adolescent Use of Cigarettes Pretest	0.19 proportion of participants Standard Deviation 0.40
Adolescent Use of Cigarettes Posttest	0.12 proportion of participants Standard Deviation 0.33

PRIMARY outcome

Timeframe: Baseline (pretest), 8 weeks (posttest)

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

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Adolescent Use of E-cigarettes Pretest	0.32 proportion of participants Standard Deviation 0.47
Adolescent Use of E-cigarettes Posttest	0.28 proportion of participants Standard Deviation 0.45

PRIMARY outcome

Timeframe: Baseline (pretest), 8 weeks (posttest)

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

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Adolescent Use of Alcohol Pretest	0.39 proportion of participants Standard Deviation 0.49
Adolescent Use of Alcohol Posttest	0.44 proportion of participants Standard Deviation 0.50

PRIMARY outcome

Timeframe: Baseline (pretest), 8 weeks (posttest)

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

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Adolescent Use of Marijuana Pretest	0.54 proportion of participants Standard Deviation 0.50
Adolescent Use of Marijuana Posttest	0.40 proportion of participants Standard Deviation 0.49

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Changes in Adolescent Mindfulness Practices - Observe Subscale Pretest	3.08 units on a scale Standard Deviation 0.75
Changes in Adolescent Mindfulness Practices - Observe Subscale Posttest	3.05 units on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Changes in Adolescent Mindfulness Practices - Describing Subscale Pretest	3.29 units on a scale Standard Deviation 0.68
Changes in Adolescent Mindfulness Practices - Describing Subscale Posttest	3.28 units on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Change in Adolescent Mindfulness Practices - Acting With Awareness Subscale Pretest	2.89 units on a scale Standard Deviation 0.48
Change in Adolescent Mindfulness Practices - Acting With Awareness Subscale Posttest	2.86 units on a scale Standard Deviation 0.57

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Change in Adolescent Mindfulness Practices - Non-judging of Inner Experiences Subscale Pretest	3.52 units on a scale Standard Deviation 0.81
Change in Adolescent Mindfulness Practices - Non-judging of Inner Experiences Subscale Posttest	3.37 units on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Change in Adolescent Mindfulness Practices - Non-reactivity to Inner Experience Subscale Pretest	2.97 units on a scale Standard Error 0.65
Change in Adolescent Mindfulness Practices - Non-reactivity to Inner Experience Subscale Posttest	2.91 units on a scale Standard Error 0.81

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Changes in Emotion Regulation - Non-acceptance of Emotional Response Subscale Pretest	1.93 units on a scale Standard Deviation 0.86
Changes in Emotion Regulation - Non-acceptance of Emotional Response Subscale Posttest	2.09 units on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Changes in Emotional Regulation - Difficulties Engaging in Goals Subscale Pretest	2.83 units on a scale Standard Deviation 1.02
Changes in Emotional Regulation - Difficulties Engaging in Goals Subscale Posttest	2.69 units on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Changes in Emotional Regulation - Impulse Control Difficulties Subscale Pretest	1.86 units on a scale Standard Deviation 0.92
Changes in Emotional Regulation - Impulse Control Difficulties Subscale Posttest	1.98 units on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Changes in Emotional Regulation - Lack of Emotional Awareness Subscale Pretest	2.79 units on a scale Standard Deviation 0.87
Changes in Emotional Regulation - Lack of Emotional Awareness Subscale Posttest	2.82 units on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Changes in Emotional Regulation - Limited Access to Emotion Regulation Strategies Subscale Pretest	2.22 units on a scale Standard Deviation 1.05
Changes in Emotional Regulation - Limited Access to Emotion Regulation Strategies Subscale Posttest	2.25 units on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: Baseline (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).

Outcome measures

Measure	App Evaluation n=58 Participants 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.
Changes in Emotional Regulation - Lack of Emotional Clarity Pretest	2.22 units on a scale Standard Deviation 0.71
Changes in Emotional Regulation - Lack of Emotional Clarity Posttest	2.31 units on a scale Standard Deviation 0.77

Adverse Events

App Evaluation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dana Smith

Oregon Research Behavioral Intervention Strategies, Inc.

Phone: 541-484-2123

Email: dana.smith@influentsin.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place