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Adolescent Substance UseNCT03533491

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

A study testing Rewire App in people with Adolescent Substance Use, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 18 years
Conditions the study is for
Adolescent Substance Use
What is being tested?
Rewire App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
30 Mar 2018to 31 Oct 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oregon Research Behavioral Intervention Strategies, Inc./Oregon Research Institute

    Eugene, Oregon, 97403

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Rewire App

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rewire AppBehavioural

    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.

Study groups in NCT03533491
Study groupRoleWhat they receive
App EvaluationExperimentalAll 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.
Receives: Behavioral: Rewire App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adolescent Use of Cigarettes

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

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

  2. Adolescent Use of E-cigarettes

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

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

  3. Adolescent Use of Alcohol

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

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

  4. Adolescent Use of Marijuana

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

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

Secondary outcomes (11)
  1. 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).

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

  2. 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).

    Measured: Baseline (pretest) and 8-weeks (posttest)

  3. 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).

    Measured: Baseline (pretest) and 8-week (posttest)

  4. 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).

    Measured: Baseline (pretest) and 8-weeks (posttest)

  5. 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).

    Measured: Baseline (pretest) and 8-week (posttest)

  6. 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).

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

  7. 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).

    Measured: Baseline (pretest) and 8-weeks (posttest)

  8. 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).

    Measured: Baseline (pretest) and 8-weeks (posttest)

  9. 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).

    Measured: Baseline (pretest) and 8-weeks (Posttest)

  10. 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).

    Measured: Baseline (pretest) and 8-week (posttest)

  11. 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).

    Measured: Baseline (pretest) and 8-weeks (posttest)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2018
  2. Study start30 Mar 2018
  3. Primary completion30 Aug 2018
  4. Study completion31 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All 60 teens in The Rewire Study will complete the first 4 modules of the Rewire app.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03533491
Sponsor's protocol ID
DA043288-01
Other IDs
1R43DA043288-01
Status last verified
Oct 2024
First submitted
17 Apr 2018
Last updated
13 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Rewire App in people with Adolescent Substance Use, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adolescent Use of Cigarettes (time frame: Baseline (pretest), 8 weeks (posttest)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

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