Trial Outcomes & Findings for VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities (NCT NCT04800757)
NCT ID: NCT04800757
Last Updated: 2022-12-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
325 participants
Primary outcome timeframe
Baseline, 4 weeks post intervention
Results posted on
2022-12-23
Participant Flow
Unit of analysis: corners
Participant milestones
| Measure |
Standard of Care
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.
|
Individual (Brief Motivational Intervention)
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.
|
Group (Group Problem Solving)
Group (Group Problem Solving): Participants will be administered a baseline survey prior to the session. The group problem solving intervention will consist of a discussion between 2-5 LDLs and a lay health promoter trained as a group facilitator. The sessions are expected to last 30-45 minutes and are intended to encourage and support Latino day laborers (LDL) to take action to reduce work-related hazards and promote worksite safety for themselves and their co-workers. 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 each 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 over the phone, four weeks post intervention, to assess participants' change in attitudes, beliefs, and risk reducing behavior and their implementation or their safety plan.
|
|---|---|---|---|
|
Overall Study
STARTED
|
113 10
|
102 10
|
110 10
|
|
Overall Study
Completed Baseline Assessment
|
112 10
|
100 10
|
106 10
|
|
Overall Study
Completed Post-Intervention Assessment
|
91 10
|
82 10
|
75 10
|
|
Overall Study
COMPLETED
|
91 10
|
82 10
|
75 10
|
|
Overall Study
NOT COMPLETED
|
22 0
|
20 0
|
35 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was not collected for one participant in the BMI arm.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=112 Participants
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.
|
Individual (Brief Motivational Intervention)
n=100 Participants
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.
|
Group (Group Problem Solving)
n=106 Participants
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.
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 12.3 • n=112 Participants • Age was not collected for one participant in the BMI arm.
|
44.1 years
STANDARD_DEVIATION 11.3 • n=99 Participants • Age was not collected for one participant in the BMI arm.
|
46.5 years
STANDARD_DEVIATION 11.3 • n=106 Participants • Age was not collected for one participant in the BMI arm.
|
45.6 years
STANDARD_DEVIATION 11.7 • n=317 Participants • Age was not collected for one participant in the BMI arm.
|
|
Sex: Female, Male
Female
|
0 Participants
n=112 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=318 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=112 Participants
|
100 Participants
n=100 Participants
|
106 Participants
n=106 Participants
|
318 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
112 Participants
n=112 Participants
|
100 Participants
n=100 Participants
|
106 Participants
n=106 Participants
|
318 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=112 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=112 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=112 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=112 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=112 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=112 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=112 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=112 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
112 Participants
n=112 Participants
|
100 Participants
n=100 Participants
|
106 Participants
n=106 Participants
|
318 Participants
n=318 Participants
|
|
Region of Enrollment
United States
|
112 Participants
n=112 Participants
|
100 Participants
n=100 Participants
|
106 Participants
n=106 Participants
|
318 Participants
n=318 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks post interventionTotal 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.
Outcome measures
| Measure |
Standard of Care
n=91 Participants
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.
|
Individual (Brief Motivational Intervention)
n=82 Participants
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.
|
Group (Group Problem Solving)
n=75 Participants
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.
|
|---|---|---|---|
|
Change in Work Hazard Exposure as Assessed by a Survey
|
-0.25 score on a scale
Standard Deviation 0.56
|
-0.07 score on a scale
Standard Deviation 0.52
|
-0.26 score on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks post interventionTotal 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.
Outcome measures
| Measure |
Standard of Care
n=91 Participants
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.
|
Individual (Brief Motivational Intervention)
n=82 Participants
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.
|
Group (Group Problem Solving)
n=75 Participants
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.
|
|---|---|---|---|
|
Change in Work Conditions as Assessed by a Survey
|
-0.21 score on a scale
Standard Error 0.54
|
-0.21 score on a scale
Standard Error 0.49
|
-0.38 score on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks post interventionThe 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.
Outcome measures
| Measure |
Standard of Care
n=91 Participants
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.
|
Individual (Brief Motivational Intervention)
n=82 Participants
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.
|
Group (Group Problem Solving)
n=75 Participants
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.
|
|---|---|---|---|
|
Change in Safety Practices as Assessed by a Survey
Safety Practices: All Items
|
-0.11 score on a scale
Standard Deviation 0.49
|
0.03 score on a scale
Standard Deviation 0.59
|
0.03 score on a scale
Standard Deviation 0.53
|
|
Change in Safety Practices as Assessed by a Survey
Safety Practices: Preparation Safety
|
-0.15 score on a scale
Standard Deviation 0.71
|
0.01 score on a scale
Standard Deviation 0.80
|
0.01 score on a scale
Standard Deviation 0.73
|
|
Change in Safety Practices as Assessed by a Survey
Safety Practices: Harm Mitigation
|
0.02 score on a scale
Standard Deviation 0.61
|
-0.01 score on a scale
Standard Deviation 0.59
|
0.06 score on a scale
Standard Deviation 0.64
|
|
Change in Safety Practices as Assessed by a Survey
Safety Practices: Proactive Communication
|
-0.16 score on a scale
Standard Deviation 0.93
|
0.04 score on a scale
Standard Deviation 1.13
|
0.10 score on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: 4 weeks post interventionPopulation: The participants in the standard of care arm did not make a safety plan; therefore, safety plan data were not collected for the standard of care arm. Also, data for this outcome measure were not collected from 34/82 participants in the Brief Motivational Intervention arm and 34/75 participants in the Group Problem Solving arm.
Participants were asked if they implemented the safety plan and they were asked to answer as yes, no or partially
Outcome measures
| Measure |
Standard of Care
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.
|
Individual (Brief Motivational Intervention)
n=48 Participants
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.
|
Group (Group Problem Solving)
n=41 Participants
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.
|
|---|---|---|---|
|
Number of Participants That Implemented the Safety Plan as Assessed by a Survey
No
|
0 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants That Implemented the Safety Plan as Assessed by a Survey
Yes
|
0 Participants
|
18 Participants
|
24 Participants
|
|
Number of Participants That Implemented the Safety Plan as Assessed by a Survey
Partially
|
0 Participants
|
25 Participants
|
12 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual (Brief Motivational Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group (Group Problem Solving)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Maria Eugenia Fernandez-Esquer
The University of Texas Health Science Center at Houston
Phone: (713) 500-9657
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place