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Completed

NCT Number: NCT03533491

The Rewire Study (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.

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Key information

Conditions

Adolescent Substance Use

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rewire App

Behavioral

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.

Primary outcomes

  1. Adolescent Use of Cigarettes

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

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

  2. Adolescent Use of E-cigarettes

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

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

  3. Adolescent Use of Alcohol

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

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

  4. Adolescent Use of Marijuana

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

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

Secondary outcomes

  1. Changes in Adolescent Mindfulness Practices - Observe Subscale

    Time frame: 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).

  2. Changes in Adolescent Mindfulness Practices - Describing Subscale

    Time frame: 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).

  3. Change in Adolescent Mindfulness Practices - Acting With Awareness Subscale

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

  6. Changes in Emotion Regulation - Non-acceptance of Emotional Response Subscale

    Time frame: 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).

  7. Changes in Emotional Regulation - Difficulties Engaging in Goals Subscale

    Time frame: 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).

  8. Changes in Emotional Regulation - Impulse Control Difficulties Subscale

    Time frame: 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).

  9. Changes in Emotional Regulation - Lack of Emotional Awareness Subscale

    Time frame: 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).

  10. Changes in Emotional Regulation - Limited Access to Emotion Regulation Strategies Subscale

    Time frame: 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).

  11. Changes in Emotional Regulation - Lack of Emotional Clarity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Oregon Research Behavioral Intervention Strategies, Inc.

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Mindfulness Mobile App to Reduce Adolescent Substance Use

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 23, 2018
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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