NCT04166162

Brief Summary

The purpose of this study is to develop and implement a community-based prevention initiative to prevent youth alcohol use and abuse in Zacatecas, Mexico.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
555

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2021

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

November 13, 2019

Last Update Submit

April 14, 2022

Conditions

Keywords

Underage Drinking

Outcome Measures

Primary Outcomes (4)

  • Sustainability of BTC coalition

    Sustainability of the BTC coalition is assessed via the number of coalition members that continues the implementation of the BTC prevention program one year after BTC training.

    1 year

  • Change in risk behaviors in TBD Intervention Recipients

    The efficacy of the TBD intervention is assessed via the changes in targeted risk and protective measures on the pre and post TBD survey. Risk factor measures with multiple items is scored by taking the average of all items in the scale. Lower scores are indicative of less risk and of positive effects of the intervention. The average scores are: minimum =1 and maximum = 4.

    Baseline, 6 weeks

  • Change in risk behaviors in SDS Intervention Recipients

    The efficacy of the SDS intervention is assessed via the SDS survey. The SDS survey is coded and scored by taking the average of all items in the scale. The higher scores are indicative of greater use of the SDS as an intervention strategy. The average scores are: minimum =1 and maximum = 4.

    Pre-SDS Intervention, Post-SDS Intervention (2 hours)

  • Change in risk behaviors in BIMI Intervention Recipients

    The efficacy of the BIMI intervention is assessed via the Care, Relax, Alone, Forget, Friends, Trouble (CRAFFT) survey. The CRAFFT survey consist of 8 questions answered with "yes" or "no". Each No response is scored 0 and each Yes response is scored 1. The total score ranges from 0-8 with the lower score indicating increased positive response to BIMI intervention.

    Baseline, 6 months

Study Arms (4)

Focus Group

EXPERIMENTAL

The Focus Group consists of the participating parents who are BTC employees with child/children in the range of 8 to 16 years old. The Focus Group will receive a total of 6 weekly sessions of the TBD Intervention.

Behavioral: Tomando Buenas Decisiones (TBD) Intervention

Social Development Strategy (SDS) Group

EXPERIMENTAL

All participating BTC workers will be receiving SDS intervention for a minimum of 1 session.

Behavioral: Social Development Strategy (SDS) Intervention

Brief Intervention Motivational Interviewing (BIMI) Group

EXPERIMENTAL

Participating 11 to 16 year old children of BTC employees will be receiving the BIMI intervention.

Behavioral: Brief Intervention Motivational Interviewing (BIMI) Intervention

Business that Care (BTC) Coalition Group

EXPERIMENTAL

Participating BTC employees who are selected by the respective directors of the participating companies to be part of the BTC Coalition will receive a total of 8 BTC training sessions in the space of 6 months.

Behavioral: BTC Training Session

Interventions

BIMI is a 15-minute brief interview in person or via video chat with participating youth. The interview will be focused on discussing the impact of drinking alcohol on one's health and how to set personal goals so that alcohol use does not become a problem. A follow up phone or video call at 3 and 6 months post initial interview will also be conducted which will track on the progress of setting and keeping personal goals.

Brief Intervention Motivational Interviewing (BIMI) Group

The program is adapted from the Guiding Good Choices (GGC) program and will be conducted by a trained facilitator lasting for about 2 hours per session. The program discusses about the best ways to help one's child make good decisions with regards to avoiding alcohol, drugs, and other problem behaviors that may not be healthy to them as well as ways to have good communication and good connections within one's family.

Focus Group

SDS is a 2 hour broad-focused environmental intervention consisting of short presentations and workshops designed to provide skills and models for positive human interaction between employees to fellow employees, employees to their children and employees to their supervisors.

Social Development Strategy (SDS) Group

BTC training session consists of trainings, discussions and tools focused on community mobilization for the assessment and implementation of evidence-informed preventive interventions addressing community health and behavior problems. Each training session lasts about 4 hours.

Business that Care (BTC) Coalition Group

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18 years or older who are actively working at one of the four BTC participating companies in Zacatecas, Mexico.
  • Must be residents of the Cities of Zacatecas or Guadalupe, in the state of Zacatecas, Mexico.
  • Workers who are illiterate or otherwise literary challenged are included.
  • Must have at least one child (biological, step or adopted) between the ages of 8 and 16 years of age.

You may not qualify if:

  • Doesn't speak Spanish.
  • Must be a child (biological, step or adopted) of a BTC employee who participated in the study.
  • Must be between the age of 11 to 16 years.
  • Doesn't speak Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Business That Care Participating Companies

Zacatecas City, Mexico

Location

MeSH Terms

Conditions

Alcohol DrinkingUnderage Drinking

Interventions

Methods

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAdolescent Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Eric Brown

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 18, 2019

Study Start

November 4, 2019

Primary Completion

July 16, 2021

Study Completion

July 16, 2021

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations