NCT03262259

Brief Summary

This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. Intervention components include screening and brief interventions by health providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

August 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

8.3 years

First QC Date

August 21, 2017

Last Update Submit

August 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health and social harms related to alcohol use

    Self-reported problems related to alcohol use (e.g., drinking and driving, injury, unwanted sex, vandalism, property crime); alcohol-related motor vehicle crashes and fatalities

    1 year

Secondary Outcomes (10)

  • Heavy/binge drinking

    1 year

  • Underage drinking

    1 year

  • Perceived alcohol use and alcohol-related attitudes among family and friends

    1 year

  • Alcohol expectancies

    1 year

  • Awareness of alcohol policies

    1 year

  • +5 more secondary outcomes

Study Arms (2)

GSDG Intervention

EXPERIMENTAL

Cities receiving a multi-component intervention, including screening and brief intervention, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation.

Behavioral: GSDG multi-component intervention

Comparison

NO INTERVENTION

Comparison cities receiving no evidence-based interventions.

Interventions

Multi-component intervention, including screening and brief intervention, other evidence-based interventions, and novel or partially tested interventions that warrant further evaluation.

GSDG Intervention

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least 12 years old
  • Parental consent is be required if under 18 years old

You may not qualify if:

  • Institutionalized individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HBSA

Calverton, Maryland, 20705, United States

RECRUITING

MeSH Terms

Conditions

Binge DrinkingUnderage Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersAlcohol DrinkingDrinking BehaviorBehaviorMental DisordersAdolescent Behavior

Study Officials

  • Ted Miller, Ph.D.

    HBSA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary V Gordon

CONTACT

Ted Miller, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Nine pairs of intervention and comparison cities followed over multiple years.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 25, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

De-identified survey and archival data collected for the evaluation will be made available upon completion of the study.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will become available upon completion of the study for an indefinite period.
Access Criteria
Not yet available.

Locations