CClinicalTrials.gg
CompletedNCT04166162Updated Apr 21, 2022

Businesses That Care - Zacatecas

An interventional study of Brief Intervention Motivational Interviewing (BIMI) Intervention and Tomando Buenas Decisiones (TBD) Intervention in Alcohol Drinking, sponsored by University of Miami. Completed at 1 site in Mexico. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by University of Miami · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
555
Allocation
Non-randomized
Ages
8 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Alcohol Drinking

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Keywords

  • Underage Drinking
03

In context

Alcohol Drinking

925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.

This study's enrollment of 555 is above the median of 108 across 802 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
555 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • BehavioralBrief 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.

  • BehavioralTomando 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.

  • BehavioralSocial 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.

  • BehavioralBTC 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: Baseline, 6 weeks

  3. 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.

    Time frame: Pre-SDS Intervention, Post-SDS Intervention (2 hours)

  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.

    Time frame: Baseline, 6 months

07

Study locations

1 site
  • Business That Care Participating Companies
    Zacatecas, Mexico
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04166162
Lead sponsor
University of Miami
Collaborators
AB InBev Foundation
Responsible party
Eric Brown (Associate Professor, University of Miami) — Principal investigator
First posted
Nov 18, 2019
Start date
Nov 4, 2019
Primary completion
Jul 16, 2021
Completion
Jul 16, 2021
Last update
Apr 21, 2022

Study contacts

Eric Brown
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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