Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 7:04 AM
Study NCT ID:
NCT04298632
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2020-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Latino Youth Agricultural Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-16', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'knowledge of pesticide safety behaviors', 'timeFrame': '7 weeks', 'description': '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"'}, {'measure': 'Self-protective behaviors', 'timeFrame': '7 weeks', 'description': '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"'}], 'secondaryOutcomes': [{'measure': 'Neurological functioning', 'timeFrame': '7 weeks', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Latino Youth'], 'conditions': ['Pesticide Safety']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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:\n\n1. 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.\n2. Delineate variation by group among adolescents' knowledge about safety behaviors.\n3. Delineate variation in adolescents' pesticide safety behaviors and neurological outcomes after intervention between all groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '12 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescent self-identifies as Latino, Hispanic, or of Latin American heritage\n* Adolescent is between the ages of 12-21\n* Adolescent has been engaged (paid or unpaid) in farm work for at least 10 hours in he last 30 days\n* Adolescent has a parent living with them\n\nExclusion Criteria:\n\n* Refusal of youth to provide assent or parent to provide consent'}, 'identificationModule': {'nctId': 'NCT04298632', 'briefTitle': 'Latino Youth Agricultural Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska Lincoln'}, 'officialTitle': 'Reducing Pesticide Exposure Among Latino Adolescents Through a Promotora-based Intervention', 'orgStudyIdInfo': {'id': '20734'}, 'secondaryIdInfos': [{'id': '2U54OH007541-16', 'link': 'https://reporter.nih.gov/quickSearch/2U54OH007541-16', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Youth-only', 'description': 'Only the youth receives the education program', 'interventionNames': ['Behavioral: Safety Education Program']}, {'type': 'EXPERIMENTAL', 'label': 'Family enhanced', 'description': 'A parent and the youth both receive the education program', 'interventionNames': ['Behavioral: Safety Education Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'neither parent, nor youth receives the education program'}], 'interventions': [{'name': 'Safety Education Program', 'type': 'BEHAVIORAL', 'description': 'this is a pesticide safety education program', 'armGroupLabels': ['Family enhanced', 'Youth-only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74106', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma State University', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data will become available within 2 years of completing the project and be available for up to five years.', 'ipdSharing': 'YES', '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska Lincoln', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}