NCT03367858

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

November 29, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.1 years

First QC Date

November 29, 2017

Results QC Date

October 17, 2023

Last Update Submit

November 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Motivational Interviewing (MI)

EXPERIMENTAL

This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.

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.

Behavioral: Brief Adolescent Mindfulness (BAM)

Interventions

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.

Motivational Interviewing (MI)

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.

Brief Adolescent Mindfulness (BAM)

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \> 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Sarah Feldstein Ewing
Organization
University of Rhode Island

Study Officials

  • Sarah Feldstein Ewing, PhD

    University of Rhode Island

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 11, 2017

Study Start

January 1, 2017

Primary Completion

January 21, 2020

Study Completion

January 21, 2020

Last Updated

November 29, 2023

Results First Posted

November 29, 2023

Record last verified: 2023-11

Locations