Work-related InjuryNCT04800757
VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities
A study testing individual -Brief Motivational Intervention (BMI) and Group (Group Problem Solving) in people with Work-related Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of VALES+Tú in reducing hazardous exposures at work and to determine the mediating effect of psychosocial stressors on VALES+Tú primary outcomes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Work-related Injury
- What is being tested?
- individual -Brief Motivational Intervention (BMI) and Group (Group Problem Solving)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2021to 2 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identify as Hispanic or Latino
- be present at the corner for the purpose of looking for work
Who cannot join
- have not been previously hired to work at a corner
- symptoms of COVID-19 in the previous 48 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers Injury Disparities
The purpose of this study is to determine the efficacy of VALES+Tú in reducing hazardous exposures at work and to determine the mediating effect of psychosocial stressors on VALES+Tú primary outcomes
- Conditions
- Work-related Injury
- Being tested
- individual -Brief Motivational Intervention (BMI), Group (Group Problem Solving), Standard of Care (OSHA 10 Safety Cards)
- Keywords
- latino day laborers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual -Brief Motivational Intervention (BMI)Behavioural
A baseline survey will be administered prior to the session.Sessions will be initiated by exploring working conditions and psychosocial factors that may influence risk for work related injuries. If the LDL is motivated to change the target behavior, a 'change plan' will be developed which involves identifying reasons for change, goals in making change, specific actions and timelines, and others who may help the person change. The final step will be the development of a personal safety plan to reduce work place risks and a discussion of the following topics: (a) how they will know if their plan is successful, (b) potential obstacles, and (c) what the worker can do if the plan does not work. Finally,each worker will be asked to write and sign a personal pledge ("Mi Promesa") to implement his own safety plan.Follow-up surveys will be conducted 4 weeks after the baseline survey.
Group (Group Problem Solving)Behavioural
Participants will be administered a baseline survey prior to session. The GPS intervention consists of a discussion between 2-5 LDLs and a trained group facilitator. The sessions will last 30-45 minutes and are intended to encourage and support Latino day laborers (LDL) to act to reduce work-related hazards and promote worksite safety. The intervention combines four participatory and group problem solving activities to engage in collaborative learning: an icebreaker, the risk identification, action planning, and Nuestra Promesa (Our Pledge). The last activity requires LDL to select a risk reduction behavior and then to fill out and sign a card detailing a pledge to implement a safety plan. Follow up surveys will be conducted four weeks post intervention, to assess participants' change in attitudes, beliefs, and risk reducing behavior and their implementation or their safety plan.
Standard of Care (OSHA 10 Safety Cards)Behavioural
Participant will be administered a baseline survey prior to the session.Participants in this standard of care control group will receive four wallet size cards with information about risk reduction strategies to deal with the four hazards responsible for most workplace fatalities in Texas: falls, struck by, heat exposure and cuts. The laminated cards are adapted from OSHA's website publicly available materials in Spanish for workers with limited literacy.
| Study group | Role | What they receive |
|---|---|---|
| individual (Brief Motivational Intervention) | Experimental | Not described Receives: Behavioral: individual -Brief Motivational Intervention (BMI) |
| Group (Group Problem Solving) | Experimental | Not described Receives: Behavioral: Group (Group Problem Solving) |
| Standard of Care | Placebo comparator | Not described Receives: Behavioral: Standard of Care (OSHA 10 Safety Cards) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Work Hazard Exposure as Assessed by a Survey
Total score on the work hazard exposure survey ranges from 1 - 4, with a higher score indicating greater work hazard exposures. The data are reported as score at post-intervention minus score at baseline.
Measured: Baseline, 4 weeks post intervention
Change in Work Conditions as Assessed by a Survey
Total score on the work conditions survey ranges from 1 - 4, with a higher score indicating greater adverse work conditions. The data are reported as score at post-intervention minus score at baseline.
Measured: Baseline, 4 weeks post intervention
Secondary outcomes (2)
Change in Safety Practices as Assessed by a Survey
The score for each of the 22 safety practices items ranged from 1-4, with a higher score indicating greater safety practice. The total score for the complete scale consisting of all 22 items is the average of items responded to and also ranged from 1-4. Separate scores for each subscale were computed similarly. The first subscale consisted of eight items; the second consisted of four items, and the third consisted of three items--the score for each subscale ranged from 1-4, with a higher score indicating greater safety practice. There were seven original items that were not associated with the subscales derived from the factor analyses. The data are reported as scores at post-intervention minus scores at baseline.
Measured: Baseline, 4 weeks post intervention
Number of Participants That Implemented the Safety Plan as Assessed by a Survey
Participants were asked if they implemented the safety plan and they were asked to answer as yes, no or partially
Measured: 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start11 May 2021
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Work-related InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Maria Eugenia Fernandez-Esquer, The University of Texas Health Science Center, Houston
- Investigators
- Maria Eugenia Fernandez-Esquer, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800757
- Sponsor's protocol ID
- HSC-SPH-18-0337
- Other IDs
- 1R01MD012928
- Status last verified
- Dec 2022
- First submitted
- 11 Mar 2021
- Last updated
- 23 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers Injury Disparities
- ClinicalTrials.gov ID
- NCT04800757
- Acronym / sponsor ID
- HSC-SPH-18-0337
- Conditions
- Work-related Injury
- Keywords
- latino day laborers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Posted 23 Dec 2022
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 determine the efficacy of VALES+Tú in reducing hazardous exposures at work and to determine the mediating effect of psychosocial stressors on VALES+Tú primary outcomes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cluster randomized
| Arm | Type | Receives |
|---|---|---|
| individual (Brief Motivational Intervention) | Experimental | Behavioral: individual -Brief Motivational Intervention (BMI) |
| Group (Group Problem Solving) | Experimental | Behavioral: Group (Group Problem Solving) |
| Standard of Care | Placebo comparator | Behavioral: Standard of Care (OSHA 10 Safety Cards) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- self-identify as Hispanic or Latino
- be present at the corner for the purpose of looking for work
Key exclusion criteria (2 listed)
- have not been previously hired to work at a corner
- symptoms of COVID-19 in the previous 48 hours
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 |
|---|---|---|
| individual -Brief Motivational Intervention (BMI)A baseline survey will be administered prior to the session.Sessions will be initiated by exploring working conditions and psychosocial factors that may influence risk for work related injuries. If the LDL is motivated to change the target behavior, a 'change plan' will be developed which involves identifying reasons for change, goals in making change, specific actions and timelines, and others who may help the person change. The final step will be the development of a personal safety plan to reduce work place risks and a discussion of the following topics: (a) how they will know if their plan is successful, (b) potential obstacles, and (c) what the worker can do if the plan does not work. Finally,each worker will be asked to write and sign a personal pledge ("Mi Promesa") to implement his own safety plan.Follow-up surveys will be conducted 4 weeks after the baseline survey. | Behavioural | individual (Brief Motivational Intervention) |
| Group (Group Problem Solving)Participants will be administered a baseline survey prior to session. The GPS intervention consists of a discussion between 2-5 LDLs and a trained group facilitator. The sessions will last 30-45 minutes and are intended to encourage and support Latino day laborers (LDL) to act to reduce work-related hazards and promote worksite safety. The intervention combines four participatory and group problem solving activities to engage in collaborative learning: an icebreaker, the risk identification, action planning, and Nuestra Promesa (Our Pledge). The last activity requires LDL to select a risk reduction behavior and then to fill out and sign a card detailing a pledge to implement a safety plan. Follow up surveys will be conducted four weeks post intervention, to assess participants' change in attitudes, beliefs, and risk reducing behavior and their implementation or their safety plan. | Behavioural | Group (Group Problem Solving) |
| Standard of Care (OSHA 10 Safety Cards)Participant will be administered a baseline survey prior to the session.Participants in this standard of care control group will receive four wallet size cards with information about risk reduction strategies to deal with the four hazards responsible for most workplace fatalities in Texas: falls, struck by, heat exposure and cuts. The laminated cards are adapted from OSHA's website publicly available materials in Spanish for workers with limited literacy. | Behavioural | Standard of Care |
Primary outcome
Change in Work Hazard Exposure as Assessed by a Survey
Time frame: Baseline, 4 weeks post intervention
Total score on the work hazard exposure survey ranges from 1 - 4, with a higher score indicating greater work hazard exposures. The data are reported as score at post-intervention minus score at baseline.
Change in Work Conditions as Assessed by a Survey
Time frame: Baseline, 4 weeks post intervention
Total score on the work conditions survey ranges from 1 - 4, with a higher score indicating greater adverse work conditions. The data are reported as score at post-intervention minus score at baseline.
2 secondary outcomes
Change in Safety Practices as Assessed by a Survey
Time frame: Baseline, 4 weeks post intervention
Number of Participants That Implemented the Safety Plan as Assessed by a Survey
Time frame: 4 weeks post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Maria Eugenia Fernandez-Esquer, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual -Brief Motivational Intervention (BMI) and Group (Group Problem Solving) in people with Work-related Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 2 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 23 Dec 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Work Hazard Exposure as Assessed by a Survey (time frame: Baseline, 4 weeks post intervention). The study lists 2 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 23 Dec 2022.