Latino Youth Agricultural Study

December 16, 2022 updated by: University of Nebraska Lincoln

Reducing Pesticide Exposure Among Latino Adolescents Through a Promotora-based Intervention

This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The goal of the project is to determine the effectiveness of each intervention in promoting increased knowledge and practice of pesticide safety behaviors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The intervention will be delivered to two different treatment groups: 1) adolescent only, adolescents receive the adapted adolescent version of La Familia Sana program and 2) family enhanced, adolescent and mother both receive the La Familia Sana program. In addition, there will be a control group where adolescent farmworkers will not be exposed to any pesticide safety program. Our project will:

  1. Determine if a promotora-based intervention targeting pesticide safety in the workplace is effective in increasing knowledge about safety behaviors among Latino adolescents engaged in farm work.
  2. Delineate variation by group among adolescents' knowledge about safety behaviors.
  3. Delineate variation in adolescents' pesticide safety behaviors and neurological outcomes after intervention between all groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74106
        • Oklahoma State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adolescent self-identifies as Latino, Hispanic, or of Latin American heritage
  • Adolescent is between the ages of 12-21
  • Adolescent has been engaged (paid or unpaid) in farm work for at least 10 hours in he last 30 days
  • Adolescent has a parent living with them

Exclusion Criteria:

  • Refusal of youth to provide assent or parent to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Youth-only
Only the youth receives the education program
Behavioral: Safety Education Program
this is a pesticide safety education program
Experimental: Family enhanced
A parent and the youth both receive the education program
Behavioral: Safety Education Program
this is a pesticide safety education program
No Intervention: Control
neither parent, nor youth receives the education program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
knowledge of pesticide safety behaviors
Time Frame: 7 weeks
This outcome measure will be assessed by a series of nine questions asking adolescents "How do you believe that farmworkers can come in contact with pesticides while working?" Additionally, nine additional questions will be asked that assess "How do you believe that farmworkers can have contact with pesticides while at home?" All responses for these questions are "yes" or "no"
7 weeks
Self-protective behaviors
Time Frame: 7 weeks
Self-protective behaviors will be assessed by items asking adolescents about their clothes wearing and handling and their hand washing behaviors. Items regarding clothes wearing and handling include self-reported frequency of removing shoes and clothes prior to entering their home and wearing the same clothes more than one day. Additionally, several questions ask about the frequency of wearing shorts, sandals, gloves, etc. Regarding hand washing behavior, adolescents will self-report their hand washing behaviors at pretest and posttest. These questions ask youth about the frequency in which they wash their hands prior to eating, drinking, chewing gum, using the restroom, touching co-workers, etc. All self-protective behavior questions have a response option of "never", "sometimes", "usually", and "always"
7 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neurological functioning
Time Frame: 7 weeks
Neurological functioning in the form of coordination and fine motor skills will be assessed by the finger tapper test. This measure focuses specifically on speed and is sensitive to the effects of neurotoxicants. The finger tapper test produces a mean score for both the participant's dominant and non-dominant hand as a result of a series of 10 second tapping exercises.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska Lincoln

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20734 (DAIDS-ES Registry Number)
  • 2U54OH007541-16 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data collected from this project will be made available to other researchers within 2 years of completing the project. Those wishing to use the data will be required to submit an application indicating the purpose for which the data will be used and documenting that the research protocol has been approved by the appropriate IRB. Any costs involved in the providing access to data (e.g., statistical and programming support, duplication of documentation) will be paid by those requesting access.

IPD Sharing Time Frame

Data will become available within 2 years of completing the project and be available for up to five years.

IPD Sharing Access Criteria

Those wishing to use the data will be required to submit an application indicating the purpose for which the data will be used and documenting that the research protocol has been approved by the appropriate IRB.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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