NCT01690026

Brief Summary

This present multi-site investigation compares a voluntary brief intervention for adolescent alcohol problems to an educational comparison condition. Measures are taken at intake and at 4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal change efforts and arrest progression of alcohol problems. This study tests cognitive mechanisms of change and treatment characteristics and processes associated with youth self-regulation to reduce or stop hazardous drinking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

4.4 years

First QC Date

September 12, 2012

Last Update Submit

November 1, 2017

Conditions

Underage Drinking

Outcome Measures

Primary Outcomes (1)

  • Alcohol use and problems

    one year

Secondary Outcomes (1)

  • Cognitive mediators

    one year

Study Arms (2)

Brief intervention

OTHER

Motivational intervention based brief intervention

Behavioral: Motivation interviewing based brief intervention

Standard intervention

OTHER

Standard intervention condition

Behavioral: Standard Intervention

Interventions

Motivation interviewing based brief interventionBEHAVIORAL
Brief intervention
Standard InterventionBEHAVIORAL
Standard intervention

Eligibility Criteria

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

You may qualify if:

  • All 9th-12th graders at six schools from 3 sites across the country are eligible to participate, regardless of alcohol experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Drug Free Youth in Town

Miami, Florida, 33157-3459, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454-1495, United States

Location

Reed College

Portland, Oregon, 97202-8199, United States

Location

MeSH Terms

Conditions

Underage Drinking

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorAlcohol DrinkingDrinking Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-Chancellor of Research

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 21, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2017

Study Completion

June 30, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

US(3)