Businesses That Care - Zacatecas

Alcohol Drinking Clinical Trial

Official title:

Businesses That Care - Zacatecas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04166162
• Other study ID #: 20190141
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: July 16, 2021

Study information

• Verified date: April 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: July 16, 2021
• Est. primary completion date: July 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Mexico	Business That Care Participating Companies	Zacatecas

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	AB InBev Foundation

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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