Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Businesses That Care - Zacatecas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04166162
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
AB InBev Foundation
Information provided by (Responsible Party):
Eric Brown, University of Miami

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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Behavioral: Brief Intervention Motivational Interviewing (BIMI) Intervention Behavioral: Tomando Buenas Decisiones (TBD) Intervention Behavioral: Social Development Strategy (SDS) Intervention Behavioral: BTC Training Session Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Businesses That Care - Zacatecas
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
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
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.

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
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.

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
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.

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
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 Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166162


Contacts
Layout table for location contacts
Contact: Eric Brown 305-243-6973 ecb41@miami.edu

Locations
Layout table for location information
Mexico
Business That Care Participating Companies Recruiting
Zacatecas, Mexico
Contact: Eric Brown    3052436973    ecb41@miami.edu   
Principal Investigator: Eric Brown         
Sponsors and Collaborators
University of Miami
AB InBev Foundation
Investigators
Layout table for investigator information
Principal Investigator: Eric Brown University of Miami

Layout table for additonal information
Responsible Party: Eric Brown, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04166162    
Other Study ID Numbers: 20190141
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Brown, University of Miami:
Underage Drinking
Additional relevant MeSH terms:
Layout table for MeSH terms
Alcohol Drinking
Drinking Behavior