NCT02448134

Brief Summary

This project evaluates a combination of policy and social influence interventions to reduce adolescent alcohol use and its sequelae.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,379

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

4.8 years

First QC Date

May 13, 2015

Last Update Submit

September 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in frequency (days per month; drinks per day) of underage alcohol use

    Alcohol Access and Attitudes Survey Youth indicated their alcohol use over the previous 30 days (i.e., "In the last 30 days, on how many days have you consumed alcoholic beverages?"). Response options included none, zero times (0), occasionally, maybe one to three times (1), fairly often, about four to six times (2), regularly, seven to nine times (3), and all the time, ten or more times (4).

    Bi-Annually, over two years

Secondary Outcomes (2)

  • Change in attitudes regarding acceptability of underage alcohol use

    Bi-Annually, over two years

  • Reward and Reminder: Value of Law Enforcement in Preventing Youth Alcohol Use

    Bi-Annually, over two years

Study Arms (2)

Youth Access

EXPERIMENTAL

Youth Engagement in Prosocial Alcohol-Free Activities Participate in the "Reward and Reminder" program in their community

Behavioral: Youth Access

Control

NO INTERVENTION

Student will receive regular information and programs.

Interventions

Youth AccessBEHAVIORAL

Community youth will participate in various school-and-community-wide pro-social, anti-alcohol activities.

Youth Access

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects will be enrolled in 9th through 11th grade in the 6 recruited communities. In year 02, we will add entering 9th graders at the same schools, and will follow 11th graders into 12th grade. We will also make use of secondary data for 8th and 11th graders.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Anthony Biglan, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 19, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations