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OpenTrials
Completed

NCT Number: NCT04166162

Businesses That Care - Zacatecas

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.

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Business That Care Participating Companies

Zacatecas City, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Intervention Motivational Interviewing (BIMI) Intervention

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • AB InBev Foundation

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2019
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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