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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Adolescent Substance Use
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Rewire App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Use of Cigarettes
Proportion of participants that use cigarettes as measured by Youth Substances Interview
Measured: Baseline (pretest), 8 weeks (posttest)
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)
Adolescent Use of Alcohol
Proportion of participants that use alcohol use as measured by Youth Substances Interview
Measured: Baseline (pretest), 8 weeks (posttest)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted23 May 2018
- Study start30 Mar 2018
- Primary completion30 Aug 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dana K Smith, Ph.D., Principal investigator, Oregon Research Institute
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Mobile App to Reduce Adolescent Substance Use
- ClinicalTrials.gov ID
- NCT03533491
- Acronym / sponsor ID
- DA043288-01
- Conditions
- Adolescent Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Posted 13 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All 60 teens in The Rewire Study will complete the first 4 modules of the Rewire app.
| Arm | Type | Receives |
|---|---|---|
| App Evaluation | Experimental | Behavioral: Rewire AppAll 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- ages 13 to 18
- involved with Juvenile Justice system
- documented substance use
- English-speaking
- living in the community
Key exclusion criteria (2 listed)
- non English-speaking
- living in treatment or detention facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rewire AppA 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. | Behavioural | App Evaluation |
Primary outcome
Adolescent Use of Cigarettes
Time frame: Baseline (pretest), 8 weeks (posttest)
Proportion of participants that use cigarettes as measured by Youth Substances Interview
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
Adolescent Use of Alcohol
Time frame: Baseline (pretest), 8 weeks (posttest)
Proportion of participants that use alcohol use as measured by Youth Substances Interview
Adolescent Use of Marijuana
Time frame: Baseline (pretest), 8 weeks (posttest)
Proportion of participants that use marijuana use as measured by Youth Substances Interview
11 secondary outcomes
Changes in Adolescent Mindfulness Practices - Observe Subscale
Time frame: Baseline (pretest), 8 weeks (posttest)
Changes in Adolescent Mindfulness Practices - Describing Subscale
Time frame: Baseline (pretest) and 8-weeks (posttest)
Change in Adolescent Mindfulness Practices - Acting With Awareness Subscale
Time frame: Baseline (pretest) and 8-week (posttest)
Change in Adolescent Mindfulness Practices - Non-judging of Inner Experiences Subscale
Time frame: Baseline (pretest) and 8-weeks (posttest)
Change in Adolescent Mindfulness Practices - Non-reactivity to Inner Experience Subscale
Time frame: Baseline (pretest) and 8-week (posttest)
Changes in Emotion Regulation - Non-acceptance of Emotional Response Subscale
Time frame: Baseline (pretest), 8 weeks (posttest)
Changes in Emotional Regulation - Difficulties Engaging in Goals Subscale
Time frame: Baseline (pretest) and 8-weeks (posttest)
Changes in Emotional Regulation - Impulse Control Difficulties Subscale
Time frame: Baseline (pretest) and 8-weeks (posttest)
Changes in Emotional Regulation - Lack of Emotional Awareness Subscale
Time frame: Baseline (pretest) and 8-weeks (Posttest)
Changes in Emotional Regulation - Limited Access to Emotion Regulation Strategies Subscale
Time frame: Baseline (pretest) and 8-week (posttest)
Changes in Emotional Regulation - Lack of Emotional Clarity
Time frame: Baseline (pretest) and 8-weeks (posttest)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana K Smith, Ph.D. principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
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.