Alcohol Use, UnspecifiedMINANCT03367858
Motivational Interviewing and Neuroimaging With Adolescents
A study testing Motivational Interviewing (MI) and Brief Adolescent Mindfulness (BAM) in people with Alcohol Use, Unspecified, run by University of Rhode Island at 1 site in United States.
Trial summary
This is a randomized controlled trial to examine the impact of two brief interventions on adolescent and young adult alcohol use behaviors and related brain response. The interventions being compared are motivational interviewing (MI) and brief adolescent mindfulness (BAM). Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Unspecified
- What is being tested?
- Motivational Interviewing (MI) and Brief Adolescent Mindfulness (BAM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 21 Jan 2020
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- within the specified age range
- >= 1 past two month binge drinking episode
- right-handed
- proficient in English
- agree to be contacted for the 3, 6, and 12 month follow ups
- informed consent of a parent/guardian, if under 18 years old
- informed assent/consent of participating youth
Who cannot join
- > 3 past-month instances of non-nicotine and/or non-cannabis substance use (e.g., methamphetamine)
- evidence of brain injury/illness or neurological disorder including psychosis
- lifetime loss of consciousness >= 2 min
- unremovable metal on/in body, or other functional magnetic resonance imaging (fMRI) contraindications (e.g., pregnancy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
This is a randomized controlled trial to examine the impact of two brief interventions on adolescent and young adult alcohol use behaviors and related brain response. The interventions being compared are motivational interviewing (MI) and brief adolescent mindfulness (BAM).
- Conditions
- Alcohol Use, Unspecified
- Being tested
- Motivational Interviewing (MI), Brief Adolescent Mindfulness (BAM)
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI)Behavioural
Motivational interviewing introduced a conversation about alcohol use, and the personally-experienced consequences of problem drinking. The MI sessions explored youths' stories around their substance use, the factors in youths' lives that support problem drinking (e.g., what they like about drinking), and the consequences of their recent or previous problem drinking (e.g., getting in trouble). Youth were provided personalized feedback about how their problem drinking compared to age-matched norms in the U.S. The ultimate goal of the MI sessions was to engage youth in a thoughtful conversation about their problem drinking with an eye to bolstering and supporting youths' own inherent drive for behavior change.
Brief Adolescent Mindfulness (BAM)Behavioural
Brief Adolescent Mindfulness introduced a conversation about what mindfulness is, and ways that it might be personally-relevant to adolescents' current experiences. This manualized treatment introduced concepts of eastern thought in a manner articulated to adolescents. Treatment included a discussion of factors in the youth's life that could be positively impacted by using or engaging mindful approaches (e.g., current experiences of stress) and a link to how mindful approaches might be applicable or relevant to the adolescent's problem drinking. The ultimate goal was to engage youth in a thoughtful conversation about BAM and how eastern thought and mindful approaches could unburden some aspects of their current lived experiences.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing (MI) | Experimental | This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing. Receives: Behavioral: Motivational Interviewing (MI) |
| Brief Adolescent Mindfulness (BAM) | Active comparator | This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness. Receives: Behavioral: Brief Adolescent Mindfulness (BAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol-related Problems
Rutgers Alcohol Problems Index (RAPI) to assess alcohol-related problems. Minimum individual value = 0; maximum individual value = 92. Higher scores mean more alcohol-related problems.
Measured: assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study startJan 2017
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use, UnspecifiedStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Feldstein Ewing, University of Rhode Island
- Investigators
- Sarah Feldstein Ewing, PhD, Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367858
- Sponsor's protocol ID
- 5R01AA023658
- Acronym
- MINA
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2017
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dash GF, Chung T, Yang M, Bryan AD, Hudson KA, Feldstein Ewing SW. Examining the influence of adolescent:provider alliance on youth hazardous drinking: Findings from a randomized controlled trial. Addict Behav. 2023 Jan;136:107499. doi: 10.1016/j.addbeh.2022.107499. Epub 2022 Sep 21.
PubMed 36166981
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing and Neuroimaging With Adolescents
- ClinicalTrials.gov ID
- NCT03367858
- Acronym / sponsor ID
- MINA / 5R01AA023658
- Conditions
- Alcohol Use, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 29 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial to examine the impact of two brief interventions on adolescent and young adult alcohol use behaviors and related brain response. The interventions being compared are motivational interviewing (MI) and brief adolescent mindfulness (BAM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing (MI) | Experimental | Behavioral: Motivational Interviewing (MI)This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing. |
| Brief Adolescent Mindfulness (BAM) | Active comparator | Behavioral: Brief Adolescent Mindfulness (BAM)This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- within the specified age range
- >= 1 past two month binge drinking episode
- right-handed
- proficient in English
- agree to be contacted for the 3, 6, and 12 month follow ups
Key exclusion criteria (4 listed)
- > 3 past-month instances of non-nicotine and/or non-cannabis substance use (e.g., methamphetamine)
- evidence of brain injury/illness or neurological disorder including psychosis
- lifetime loss of consciousness >= 2 min
- unremovable metal on/in body, or other functional magnetic resonance imaging (fMRI) contraindications (e.g., pregnancy)
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 |
|---|---|---|
| Motivational Interviewing (MI)Motivational interviewing introduced a conversation about alcohol use, and the personally-experienced consequences of problem drinking. The MI sessions explored youths' stories around their substance use, the factors in youths' lives that support problem drinking (e.g., what they like about drinking), and the consequences of their recent or previous problem drinking (e.g., getting in trouble). Youth were provided personalized feedback about how their problem drinking compared to age-matched norms in the U.S. The ultimate goal of the MI sessions was to engage youth in a thoughtful conversation about their problem drinking with an eye to bolstering and supporting youths' own inherent drive for behavior change. | Behavioural | Motivational Interviewing (MI) |
| Brief Adolescent Mindfulness (BAM)Brief Adolescent Mindfulness introduced a conversation about what mindfulness is, and ways that it might be personally-relevant to adolescents' current experiences. This manualized treatment introduced concepts of eastern thought in a manner articulated to adolescents. Treatment included a discussion of factors in the youth's life that could be positively impacted by using or engaging mindful approaches (e.g., current experiences of stress) and a link to how mindful approaches might be applicable or relevant to the adolescent's problem drinking. The ultimate goal was to engage youth in a thoughtful conversation about BAM and how eastern thought and mindful approaches could unburden some aspects of their current lived experiences. | Behavioural | Brief Adolescent Mindfulness (BAM) |
Primary outcome
Alcohol-related Problems
Time frame: assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported
Rutgers Alcohol Problems Index (RAPI) to assess alcohol-related problems. Minimum individual value = 0; maximum individual value = 92. Higher scores mean more alcohol-related problems.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36166981Dash GF, Chung T, Yang M, Bryan AD, Hudson KA, Feldstein Ewing SW. Examining the influence of adolescent:provider alliance on youth hazardous drinking: Findings from a randomized controlled trial. Addict Behav. 2023 Jan;136:107499. doi: 10.1016/j.addbeh.2022.107499. Epub 2022 Sep 21.
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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.
Sarah Feldstein Ewing, PhD principal investigator
University of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing (MI) and Brief Adolescent Mindfulness (BAM) in people with Alcohol Use, Unspecified, run by University of Rhode Island 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 7 inclusion and 4 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 29 Nov 2023. 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 29 Nov 2023). 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?
Alcohol-related Problems (time frame: assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03367858, which also lists 1 linked publication.
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 29 Nov 2023.