Back to resultsBusinesses That Care - Zacatecas
Primary Purpose
Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Brief Intervention Motivational Interviewing (BIMI) Intervention
Tomando Buenas Decisiones (TBD) Intervention
Social Development Strategy (SDS) Intervention
BTC Training Session
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Drinking focused on measuring Underage Drinking
Eligibility 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.
Sites / Locations
- Business That Care Participating Companies
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Focus Group
Social Development Strategy (SDS) Group
Brief Intervention Motivational Interviewing (BIMI) Group
Business that Care (BTC) Coalition Group
Arm Description
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.
All participating BTC workers will be receiving SDS intervention for a minimum of 1 session.
Participating 11 to 16 year old children of BTC employees will be receiving the BIMI intervention.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04166162
First Posted
November 13, 2019
Last Updated
April 14, 2022
Sponsor
University of Miami
Collaborators
AB InBev Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04166162
Brief Title
Businesses That Care - Zacatecas
Official Title
Businesses That Care - Zacatecas
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
July 16, 2021 (Actual)
Study Completion Date
July 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
AB InBev Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Underage Drinking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
555 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focus Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Social Development Strategy (SDS) Group
Arm Type
Experimental
Arm Description
All participating BTC workers will be receiving SDS intervention for a minimum of 1 session.
Arm Title
Brief Intervention Motivational Interviewing (BIMI) Group
Arm Type
Experimental
Arm Description
Participating 11 to 16 year old children of BTC employees will be receiving the BIMI intervention.
Arm Title
Business that Care (BTC) Coalition Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention Motivational Interviewing (BIMI) Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tomando Buenas Decisiones (TBD) Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Development Strategy (SDS) Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BTC Training Session
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sustainability of BTC coalition
Description
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.
Time Frame
1 year
Title
Change in risk behaviors in TBD Intervention Recipients
Description
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.
Time Frame
Baseline, 6 weeks
Title
Change in risk behaviors in SDS Intervention Recipients
Description
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.
Time Frame
Pre-SDS Intervention, Post-SDS Intervention (2 hours)
Title
Change in risk behaviors in BIMI Intervention Recipients
Description
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.
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Brown
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Business That Care Participating Companies
City
Zacatecas
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Businesses That Care - Zacatecas
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