Businesses That Care - Zacatecas
1 other identifier
interventional
555
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2019
CompletedFirst Submitted
Initial submission to the registry
November 13, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2021
CompletedApril 21, 2022
April 1, 2022
1.7 years
November 13, 2019
April 14, 2022
Conditions
Keywords
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
EXPERIMENTALThe 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.
Social Development Strategy (SDS) Group
EXPERIMENTALAll participating BTC workers will be receiving SDS intervention for a minimum of 1 session.
Brief Intervention Motivational Interviewing (BIMI) Group
EXPERIMENTALParticipating 11 to 16 year old children of BTC employees will be receiving the BIMI intervention.
Business that Care (BTC) Coalition Group
EXPERIMENTALParticipating 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.
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.
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.
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 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.
Eligibility Criteria
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
- University of Miamilead
- AB InBev Foundationcollaborator
Study Sites (1)
Business That Care Participating Companies
Zacatecas City, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Brown
University of Miami
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