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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03367858
Other study ID # 5R01AA023658
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date January 21, 2020

Study information

Verified date November 2023
Source University of Rhode Island
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date January 21, 2020
Est. primary completion date January 21, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 19 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
University of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported
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