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VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities

Primary Purpose

Work-related Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
individual -Brief Motivational Intervention (BMI)
Group (Group Problem Solving)
Standard of Care (OSHA 10 Safety Cards)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Work-related Injury focused on measuring latino day laborers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • self-identify as Hispanic or Latino
  • be present at the corner for the purpose of looking for work

Exclusion Criteria:

  • have not been previously hired to work at a corner
  • symptoms of COVID-19 in the previous 48 hours

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

individual (Brief Motivational Intervention)

Group (Group Problem Solving)

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
March 11, 2021
Last Updated
December 3, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04800757
Brief Title
VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities
Official Title
VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers Injury Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work-related Injury
Keywords
latino day laborers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
individual (Brief Motivational Intervention)
Arm Type
Experimental
Arm Title
Group (Group Problem Solving)
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
individual -Brief Motivational Intervention (BMI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group (Group Problem Solving)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care (OSHA 10 Safety Cards)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Work Hazard Exposure as Assessed by a Survey
Description
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.
Time Frame
Baseline, 4 weeks post intervention
Title
Change in Work Conditions as Assessed by a Survey
Description
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.
Time Frame
Baseline, 4 weeks post intervention
Secondary Outcome Measure Information:
Title
Change in Safety Practices as Assessed by a Survey
Description
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.
Time Frame
Baseline, 4 weeks post intervention
Title
Number of Participants That Implemented the Safety Plan as Assessed by a Survey
Description
Participants were asked if they implemented the safety plan and they were asked to answer as yes, no or partially
Time Frame
4 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: self-identify as Hispanic or Latino be present at the corner for the purpose of looking for work Exclusion Criteria: have not been previously hired to work at a corner symptoms of COVID-19 in the previous 48 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Eugenia Fernandez-Esquer, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities

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