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Motivational Interviewing and Neuroimaging With Adolescents (MINA)

Primary Purpose

Alcohol Use, Unspecified

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing (MI)
Brief Adolescent Mindfulness (BAM)
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use, Unspecified

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • within the specified age range
  • 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:

- unremovable metal on/in body, or other fMRI contraindications (e.g., pregnancy)

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Interviewing (MI)

Brief Adolescent Mindfulness (BAM)

Arm Description

Outcomes

Primary Outcome Measures

Self-reported alcohol use

Secondary Outcome Measures

Full Information

First Posted
November 29, 2017
Last Updated
October 31, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03367858
Brief Title
Motivational Interviewing and Neuroimaging With Adolescents
Acronym
MINA
Official Title
Motivational Interviewing and Neuroimaging With Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a randomized controlled trial to examine the impact of two brief interventions on adolescent and young adult alcohol use behaviors. The interventions being compared are motivational interviewing (MI) and brief adolescent mindfulness (BAM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Unspecified

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing (MI)
Arm Type
Experimental
Arm Title
Brief Adolescent Mindfulness (BAM)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (MI)
Intervention Type
Behavioral
Intervention Name(s)
Brief Adolescent Mindfulness (BAM)
Primary Outcome Measure Information:
Title
Self-reported alcohol use
Time Frame
Change from baseline across study timepoints (3-, 6-, and 12-months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: within the specified age range 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: - unremovable metal on/in body, or other fMRI contraindications (e.g., pregnancy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Feldstein Ewing, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36166981
Citation
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.
Results Reference
derived

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Motivational Interviewing and Neuroimaging With Adolescents

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