- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03367858
Motivational Interviewing and Neuroimaging With Adolescents (MINA)
November 9, 2023 updated by: Sarah Feldstein Ewing, University of Rhode Island
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
204
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- > 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motivational Interviewing (MI)
This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.
|
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.
|
|
Active Comparator: Brief Adolescent Mindfulness (BAM)
This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah Feldstein Ewing, PhD, University of Rhode Island
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
January 21, 2020
Study Completion (Actual)
January 21, 2020
Study Registration Dates
First Submitted
November 29, 2017
First Submitted That Met QC Criteria
December 4, 2017
First Posted (Actual)
December 11, 2017
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 9, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01AA023658 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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