Businesses That Care - Zacatecas

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: Tomando Buenas Decisiones (TBD) Intervention; Behavioral: Social Development Strategy (SDS) Intervention; Behavioral: Brief Intervention Motivational Interviewing (BIMI) Intervention; Behavioral: BTC Training Session

• Study Type: Interventional
• Enrollment (Actual): 555
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Zacatecas, Mexico
    • Business That Care Participating Companies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria for Parent Participants:

• 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.

Exclusion Criteria for Parent Participants:

• Doesn't speak Spanish.

Inclusion Criteria for Children Participants:

• 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.

Exclusion Criteria for Children Participants:

• Doesn't speak Spanish.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Focus Group; 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; 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.
EXPERIMENTAL: Social Development Strategy (SDS) Group; All participating BTC workers will be receiving SDS intervention for a minimum of 1 session.	Behavioral: Social Development Strategy (SDS) Intervention; 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.
EXPERIMENTAL: Brief Intervention Motivational Interviewing (BIMI) Group; Participating 11 to 16 year old children of BTC employees will be receiving the BIMI intervention.	Behavioral: Brief Intervention Motivational Interviewing (BIMI) Intervention; 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.
EXPERIMENTAL: Business that Care (BTC) Coalition Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: AB InBev Foundation
• Investigators: Principal Investigator: Eric Brown, University of Miami

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2019
• Primary Completion (ACTUAL): July 16, 2021
• Study Completion (ACTUAL): July 16, 2021

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (ACTUAL): November 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Underage Drinking
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 20190141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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