Businesses That Care - Zacatecas

• ClinicalTrials.gov Identifier: NCT04166162
• Recruitment Status: Active, not recruiting
• First Posted: November 18, 2019
• Last Update Posted: December 8, 2020
• Sponsor: University of Miami
• Collaborator: AB InBev Foundation
• Information provided by (Responsible Party): Eric Brown, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alcohol Drinking	Behavioral: Brief Intervention Motivational Interviewing (BIMI) Intervention; Behavioral: Tomando Buenas Decisiones (TBD) Intervention; Behavioral: Social Development Strategy (SDS) Intervention; Behavioral: BTC Training Session	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 288 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Businesses That Care - Zacatecas
• Actual Study Start Date: November 4, 2019
• Estimated Primary Completion Date: March 31, 2021
• Estimated Study Completion Date: March 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Sustainability of BTC coalition [ Time Frame: 1 year ]
   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.
2. Change in risk behaviors in TBD Intervention Recipients [ Time Frame: Baseline, 6 weeks ]
   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.
3. Change in risk behaviors in SDS Intervention Recipients [ Time Frame: Pre-SDS Intervention, Post-SDS Intervention (2 hours) ]
   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.
4. Change in risk behaviors in BIMI Intervention Recipients [ Time Frame: Baseline, 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 8 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Mexico

Business That Care Participating Companies

Zacatecas, Mexico

Sponsors and Collaborators

University of Miami

AB InBev Foundation

Investigators

• Principal Investigator: Eric Brown; University of Miami

More Information

• Responsible Party: Eric Brown, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT04166162
• Other Study ID Numbers: 20190141
• First Posted: November 18, 2019
• Last Update Posted: December 8, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eric Brown, University of Miami:

Underage Drinking

Additional relevant MeSH terms:

Alcohol Drinking; Drinking Behavior