Businesses That Care - Zacatecas
Businesses That Care - Zacatecas
Sponsors
Source
University of Miami
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Recruiting
Start Date
2019-11-04
Completion Date
2020-12-31
Primary Completion Date
2020-12-31
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Sustainability of BTC coalition |
1 year |
|
Change in risk behaviors in TBD Intervention Recipients |
Baseline, 6 weeks |
|
Change in risk behaviors in SDS Intervention Recipients |
Pre-SDS Intervention, Post-SDS Intervention (2 hours) |
|
Change in risk behaviors in BIMI Intervention Recipients |
Baseline, 6 months |
Enrollment
288
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
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.
Arm Group Label
Brief Intervention Motivational Interviewing (BIMI) Group
Intervention Type
Behavioral
Intervention Name
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.
Arm Group Label
Focus Group
Intervention Type
Behavioral
Intervention Name
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.
Arm Group Label
Social Development Strategy (SDS) Group
Intervention Type
Behavioral
Intervention Name
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.
Arm Group Label
Business that Care (BTC) Coalition Group
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.
Gender
All
Minimum Age
8 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Eric Brown |
Principal Investigator |
University of Miami |
Overall Contact
Location
Facility |
Status |
Contact |
Investigator |
|
Business That Care Participating Companies Zacatecas Mexico |
Recruiting |
Last Name: Eric Brown Role: Principal Investigator |
Location Countries
Country
Mexico
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of Miami
Investigator Full Name
Eric Brown
Investigator Title
Associate Professor
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
4
Arm Group
Arm Group Label
Focus Group
Arm Group Type
Experimental
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 Group Label
Social Development Strategy (SDS) Group
Arm Group Type
Experimental
Description
All participating BTC workers will be receiving SDS intervention for a minimum of 1 session.
Arm Group Label
Brief Intervention Motivational Interviewing (BIMI) Group
Arm Group Type
Experimental
Description
Participating 11 to 16 year old children of BTC employees will be receiving the BIMI intervention.
Arm Group Label
Business that Care (BTC) Coalition Group
Arm Group Type
Experimental
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.
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)
Study First Submitted
November 13, 2019
Study First Submitted Qc
November 13, 2019
Study First Posted
November 18, 2019
Last Update Submitted
November 13, 2019
Last Update Submitted Qc
November 13, 2019
Last Update Posted
November 18, 2019
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.