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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Completed

CT.gov ID

NCT04800757

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

318

Enrollment

Location

Arms

5.7

Actual Duration (Months)

55.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Work-related Injury	Behavioral: individual -Brief Motivational Intervention (BMI) Behavioral: Group (Group Problem Solving) Behavioral: Standard of Care (OSHA 10 Safety Cards)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

318 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster randomizedCluster randomized

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 11, 2021

Actual Primary Completion Date :

Nov 2, 2021

Actual Study Completion Date :

Nov 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: individual (Brief Motivational Intervention)	Behavioral: 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.
Experimental: Group (Group Problem Solving)	Behavioral: Group (Group Problem Solving) Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan.
Placebo Comparator: Standard of Care	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: individual (Brief Motivational Intervention)

Behavioral: 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.

Experimental: Group (Group Problem Solving)

Behavioral: Group (Group Problem Solving)

Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan.

Placebo Comparator: Standard of Care

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Change in work hazard exposure as assessed by a survey [Baseline, 4 weeks post intervention]
Exposures will be reported categorically as never,sometimes,many times,all the time, does not know and refused
Change in work conditions as assessed by a survey [Baseline, 4 weeks post intervention]
Work conditions will be reported categorically as never,sometimes,many times,all the time, does not know and refused

Secondary Outcome Measures

Change in safety practices as assessed by a survey [Baseline, 4 weeks post intervention]
safety practices will be reported categorically as never,sometimes,many times,all the time, does not know and refused
Number of participants that implemented the safety plan as assessed by a survey [4 weeks post intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Principal Investigator: Maria Eugenia Fernandez-Esquer, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Eugenia Fernandez-Esquer, Associate Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT04800757

Other Study ID Numbers:

HSC-SPH-18-0337
1R01MD012928

First Posted:

Mar 16, 2021

Last Update Posted:

May 20, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maria Eugenia Fernandez-Esquer, Associate Professor, The University of Texas Health Science Center, Houston

latino day laborers

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of May 20, 2022