Alcohol DrinkingNCT04166162
Businesses That Care - Zacatecas
A study testing Brief Intervention Motivational Interviewing (BIMI) Intervention, Tomando Buenas Decisiones (TBD) Intervention and Social Development Strategy (SDS) Intervention in people with Alcohol Drinking, run by University of Miami at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Brief Intervention Motivational Interviewing (BIMI) Intervention, Tomando Buenas Decisiones (TBD) Intervention and Social Development Strategy (SDS) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 1 siteMexico
- Study dates
- 4 Nov 2019to 16 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- Doesn't speak Spanish.
- Doesn't speak Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alcohol Drinking
- Being tested
- Brief Intervention Motivational Interviewing (BIMI) Intervention, Tomando Buenas Decisiones (TBD) Intervention, Social Development Strategy (SDS) Intervention, BTC Training Session
- Keywords
- Underage Drinking
- Medical subject headings
- Alcohol Drinking, Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intervention Motivational Interviewing (BIMI) InterventionBehavioural
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) InterventionBehavioural
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) InterventionBehavioural
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 SessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | Experimental | 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. Receives: Behavioral: Tomando Buenas Decisiones (TBD) Intervention |
| Social Development Strategy (SDS) Group | Experimental | All participating BTC workers will be receiving SDS intervention for a minimum of 1 session. Receives: Behavioral: Social Development Strategy (SDS) Intervention |
| Brief Intervention Motivational Interviewing (BIMI) Group | Experimental | Participating 11 to 16 year old children of BTC employees will be receiving the BIMI intervention. Receives: Behavioral: Brief Intervention Motivational Interviewing (BIMI) Intervention |
| Business that Care (BTC) Coalition Group | Experimental | 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. Receives: Behavioral: BTC Training Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: Baseline, 6 weeks
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.
Measured: Pre-SDS Intervention, Post-SDS Intervention (2 hours)
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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start4 Nov 2019
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- AB InBev Foundation
- Responsible party
- Principal investigator, Eric Brown, University of Miami
- Investigators
- Eric Brown, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166162
- Sponsor's protocol ID
- 20190141
- Status last verified
- Apr 2022
- First submitted
- 13 Nov 2019
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Businesses That Care - Zacatecas
- ClinicalTrials.gov ID
- NCT04166162
- Acronym / sponsor ID
- 20190141
- Conditions
- Alcohol Drinking
- Keywords
- Underage Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- AB InBev Foundation
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Focus Group | Experimental | Behavioral: Tomando Buenas Decisiones (TBD) InterventionThe 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. |
| Social Development Strategy (SDS) Group | Experimental | Behavioral: Social Development Strategy (SDS) InterventionAll participating BTC workers will be receiving SDS intervention for a minimum of 1 session. |
| Brief Intervention Motivational Interviewing (BIMI) Group | Experimental | Behavioral: Brief Intervention Motivational Interviewing (BIMI) InterventionParticipating 11 to 16 year old children of BTC employees will be receiving the BIMI intervention. |
| Business that Care (BTC) Coalition Group | Experimental | Behavioral: BTC Training SessionParticipating 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Must be a child (biological, step or adopted) of a BTC employee who participated in the study.
Key exclusion criteria (2 listed)
- Doesn't speak Spanish.
- Doesn't speak Spanish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Intervention Motivational Interviewing (BIMI) InterventionBIMI 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. | Behavioural | Brief Intervention Motivational Interviewing (BIMI) Group |
| Tomando Buenas Decisiones (TBD) InterventionThe 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. | Behavioural | Focus Group |
| Social Development Strategy (SDS) InterventionSDS 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. | Behavioural | Social Development Strategy (SDS) Group |
| BTC Training SessionBTC 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. | Behavioural | Business that Care (BTC) Coalition Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Brown principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention Motivational Interviewing (BIMI) Intervention, Tomando Buenas Decisiones (TBD) Intervention and Social Development Strategy (SDS) Intervention in people with Alcohol Drinking, run by University of Miami at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustainability of BTC coalition (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.