Evaluation of Global Smart Drinking Goals Initiative (GSDG)

Measurement and Evaluation of Global Smart Drinking Goals Initiative

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.

Study Overview

• Status: Recruiting
• Conditions: Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms
• Intervention / Treatment: Behavioral: GSDG multi-component intervention

Detailed Description

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. The trial is expected to expand to nine intervention and nine comparison cities in 2018. 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.

Multiple years of pre- and post-intervention survey data will be collected from cross-sectional samples of adults and youth in each city to assess intervention effects on harmful alcohol use. Multiple years of archival data will also be collected from each city to assess intervention effects on alcohol-related harms such as motor vehicle crashes and fatalities, violence and unintentional injuries. Multi-level analyses will be conducted with data for the total sample of 18 cities and for each pair of cities to determine whether the overall goal of reducing harmful alcohol use by at least 10% is achieved.

• Study Type: Interventional
• Enrollment (Anticipated): 36000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mallie J Paschall, Ph.D.; Phone Number: 5108835753; Email: paschall@prev.org
• Study Contact Backup: Name: Ted Miller, Ph.D.; Phone Number: 301-593-7471; Email: miller@pire.org

Study Locations

• United States
  • Maryland
    • Calverton, Maryland, United States, 20705
      • Recruiting
      • HBSA
      • Contact: Ted Miller, Ph.D.; Phone Number: 301-593-7471; Email: miller@pire.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Institutionalized individuals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSDG Intervention; 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; Multi-component intervention, including screening and brief intervention, other evidence-based interventions, and novel or partially tested interventions that warrant further evaluation.
No Intervention: Comparison; Comparison cities receiving no evidence-based interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heavy/binge drinking	Self-reported heavy alcohol use (e.g., 5+ drinks within 2 hours)	1 year
Underage drinking	Self-reported alcohol use	1 year
Perceived alcohol use and alcohol-related attitudes among family and friends	Beliefs regarding alcohol use among family and friends, and acceptability of alcohol use	1 year
Alcohol expectancies	Expectations regarding positive and negative consequences of alcohol use	1 year
Awareness of alcohol policies	Knowledge of policies such as the minimum legal drinking age and maximum allowable blood alcohol concentration limit for driving	1 year
Perceived enforcement of alcohol policies	Perceived likelihood of being asked for age identification, being stopped by police for drinking and driving, etc.	1 year
Awareness of chronic health risks associated with alcohol use	Self-reported knowledge of possible chronic health-related consequences of alcohol use (e.g., liver cirrhosis, coronary heart disease)	1 year
Awareness of alcohol health guidance labels and information	Self-reported knowledge of guidance labels and information on beer bottles, cans and elsewhere	1 year
Consumption of no-alcohol and low-alcohol beer	Self-reported consumption (quantity and frequency) of no-alcohol and low-alcohol beer, no-alcohol and low-alcohol beer sales, underage use of no-alcohol and low-alcohol beer	1 year
Screening and brief intervention for heavy/binge drinking	Self-reported frequency and impacts, archival medical record data	1 year

Collaborators and Investigators

• Sponsor: HBSA
• Investigators: Principal Investigator: Ted Miller, Ph.D., HBSA

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Binge Drinking; Underage Drinking
• Other Study ID Numbers: 0881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified survey and archival data collected for the evaluation will be made available upon completion of the study.
• IPD Sharing Time Frame: Data will become available upon completion of the study for an indefinite period.
• IPD Sharing Access Criteria: Not yet available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No