- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298632
Latino Youth Agricultural Study
Reducing Pesticide Exposure Among Latino Adolescents Through a Promotora-based Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- Delineate variation by group among adolescents' knowledge about safety behaviors.
- Delineate variation in adolescents' pesticide safety behaviors and neurological outcomes after intervention between all groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74106
- Oklahoma State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Youth-only
Only the youth receives the education program
|
this is a pesticide safety education program
|
Experimental: Family enhanced
A parent and the youth both receive the 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
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID 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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Pesticide Safety
-
National Institute of Environmental Health Sciences...Terminated
-
University of FloridaCompleted
-
National Institute of Environmental Health Sciences...CompletedPesticide ExposureUnited States
-
National Institute of Environmental Health Sciences...CompletedPesticide ExposureUnited States
-
Aya Sabry Mohamed MohamedRecruitingPesticide PoisoningEgypt
-
Centre Hospitalier Universitaire, AmiensCompleted
-
Assiut UniversityNot yet recruiting
-
Centre Hospitalier Universitaire, AmiensCompletedPollution; Exposure | Newborn | Microbiota | Breast Milk | Meconium | Pesticide | StoolFrance
-
University of EdinburghToxicology Society of BangladeshRecruitingPesticide Poisoning | Anticholinesterase Insecticide PoisoningBangladesh
-
University of EdinburghUniversity of Copenhagen; University of Oxford; University of Bristol; University... and other collaboratorsCompletedA Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural AsiaPesticide PoisoningSri Lanka
Clinical Trials on Safety Education Program
-
Johns Hopkins UniversityNational Institute on Aging (NIA)CompletedDementiaUnited States
-
Johns Hopkins UniversityAmerican SIDS InstituteNot yet recruitingSudden Infant Death
-
Centers for Disease Control and PreventionPacific Institute for Research and EvaluationCompletedWounds and Injuries | BurnsUnited States
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedUrinary Tract Infection | Pressure Ulcer | Accidental FallsNetherlands
-
Örebro University, SwedenCompletedSexual Behavior | Chlamydia Infections | Condom Use | Prevention | Safe Sex | Attitude
-
Johns Hopkins UniversityNational Institute of Nursing Research (NINR)CompletedAlzheimer's DiseaseUnited States
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...UnknownCognitive Development | Emotional DevelopmentUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)CompletedHypertension | Diabetes Mellitus | DyslipidemiasUnited States
-
Klein Buendel, Inc.National Cancer Institute (NCI); University of Colorado, DenverCompleted
-
University of DelawareActive, not recruitingDevelopmental Delay | Infant DevelopmentUnited States