Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-01-02 @ 3:18 AM
Study NCT ID:
NCT05602350
Status:
UNKNOWN
Last Update Posted:
2022-11-02
First Post:
2022-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing Response Bias on Sensitive Topics in Self- Versus Enumerator-administered Surveys
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000087302', 'term': 'Bias, Implicit'}], 'ancestors': [{'id': 'D011287', 'term': 'Prejudice'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-09-23', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main outcome is the mean difference in survey responses for an average of the three indexes being measured', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Three survey sections are being tested: (1) antisocial behaviors, (2) depression symptoms, and (3) anxiety symptoms. Each section can be summarized by a single index of survey questions in that section--indexes of antisocial behavior, depression and anxiety. To reduce the number of hypotheses tested, the researchers plan to test the difference by treatment status for an average of these three indexes. The researchers also plan to test the mean difference by treatment status for each of the three indexes, and will report regular standard errors as well as standard errors corrected for three comparisons.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bias, Implicit']}, 'descriptionModule': {'briefSummary': 'Within a survey of adolescent males in Medellin schools (mainly 13-year old boys) the researchers are randomizing whether survey respondents answer sensitive questions themselves or are asked the questions by an enumerator. Questions are of three main varieties: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All male students in seventh grade in a sample of public schools are eligible. The sample corresponds to a representative sample of public schools (we aim at 90 schools)\n\nExclusion Criteria:\n\n* Female students or students not in seventh grade'}, 'identificationModule': {'nctId': 'NCT05602350', 'briefTitle': 'Testing Response Bias on Sensitive Topics in Self- Versus Enumerator-administered Surveys', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Testing Response Bias on Sensitive Topics in Self- Versus Enumerator-administered Surveys', 'orgStudyIdInfo': {'id': 'IRB19-1212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Survey respondents will self-administer three survey sections in a tablet: (1) antisocial behaviors, (2) depression symptoms, and (3) anxiety symptoms', 'interventionNames': ['Behavioral: Self-administered survey']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Survey respondents will have the survey questions on the three sections administered by an enumerator', 'interventionNames': ['Behavioral: Enumerator-administered survey']}], 'interventions': [{'name': 'Self-administered survey', 'type': 'BEHAVIORAL', 'description': 'Subjects will self-administer questionnaire sections on sensitive topics: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.', 'armGroupLabels': ['Treatment']}, {'name': 'Enumerator-administered survey', 'type': 'BEHAVIORAL', 'description': 'Subjects will have enumerator-administered questionnaire sections on sensitive topics: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050021', 'city': 'Medellín', 'state': 'Antioquia', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Juan P Mesa, MSc', 'role': 'CONTACT', 'email': 'jpmesa@poverty-action.org', 'phone': '3012898589'}], 'facility': 'Innovations for Poverty Action', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'centralContacts': [{'name': 'Cristopher Blattman, PhD', 'role': 'CONTACT', 'email': 'blattman@uchicago.edu', 'phone': '7737028400'}, {'name': 'Santiago Tobon, PhD', 'role': 'CONTACT', 'email': 'stobonz@eafit.edu.co', 'phone': '7737028400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovations for Poverty Action', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ramalee E. Pearson Professor of Global Conflict Studies', 'investigatorFullName': 'Christopher Blattman', 'investigatorAffiliation': 'University of Chicago'}}}}