Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-20 @ 4:45 PM
Study NCT ID:
NCT05839457
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2023-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addressing School-related Gender-based Violence as Part of the Keeping Girls in School Initiative in Zambia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-04-19', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Teachers' knowledge of SRGBV", 'timeFrame': '~4 months post-intervention', 'description': 'the fraction of correct responses to 12 questions that ask whether an act is considered violence'}, {'measure': "Teachers' assessment of school climate", 'timeFrame': '~4 months post-intervention', 'description': 'An index based on 17 items that measure to what extent the school climate is safe for both boys and girls'}, {'measure': 'Attitudes towards gender roles and SRGBV (teachers)', 'timeFrame': '~4 months post-intervention', 'description': 'A normalized index based on 16 items that measure attitudes towards gender roles, SRGBV, and support to victims'}], 'primaryOutcomes': [{'measure': 'Experience of any SRGBV, past two weeks', 'timeFrame': 'two weeks prior to the endline survey', 'description': 'A binary variable of self-reported experience of any SRGBV in the past two weeks'}, {'measure': 'Experience of any SRGBV, past school term', 'timeFrame': '~4 months (Term 3 of School Year 2023)', 'description': 'A binary variable of self-reported experience of any SRGBV in the past school term'}, {'measure': 'Attitudes towards gender roles and SRGBV (adolescents)', 'timeFrame': '~4 months post-intervention', 'description': 'A normalized index based on 16 items that measure attitudes towards gender roles, SRGBV, and support to victims'}, {'measure': 'School climate', 'timeFrame': '~4 months post-intervention', 'description': 'A composite score based on 16 statements about aspects of school climate and student-teacher interactions'}, {'measure': 'Socio-emotional well-being', 'timeFrame': '~4 months post-intervention', 'description': 'A normalized index based on 3 scales related to subjective well-being: perceived social support; perceived safety; and anxiety.'}], 'secondaryOutcomes': [{'measure': 'Knowledge of SRGBV', 'timeFrame': '~4 months post-intervention', 'description': 'the fraction of correct responses to 12 questions that ask whether an act is considered violence'}, {'measure': 'School absenteeism', 'timeFrame': 'one month prior to the endline survey', 'description': 'number of days an adolescent missed in the last completed month'}, {'measure': 'School enrollment', 'timeFrame': '~4 months post-intervention', 'description': 'A binary indicator for school enrollment status'}, {'measure': 'General self-efficacy', 'timeFrame': '~4 months post-intervention', 'description': 'a composite score of 10 items on the General self-efficacy scale.'}, {'measure': 'Assertive communication', 'timeFrame': '~4 months post-intervention', 'description': 'a composite score of 6 items on the Assertiveness Communication scale'}, {'measure': 'Gender equitable injunctive norms', 'timeFrame': '~4 months post-intervention', 'description': 'A composite score of injunctive norms for gender equality norms, GBV, Corporal punishment, and GBV reporting'}, {'measure': 'Gender equitable descriptive norms', 'timeFrame': '~4 months post-intervention', 'description': 'A composite score of descriptive norms for gender equality, GBV, Corporal punishment, and GBV reporting'}, {'measure': 'Experience of sexual violence, past two weeks', 'timeFrame': '2 weeks prior to the endline survey', 'description': 'A binary variable of self-reported experience of any type of sexual violence reported by the respondent'}, {'measure': 'Experience of emotional violence, past two weeks', 'timeFrame': '2 weeks prior to the endline survey', 'description': 'A binary variable of self-reported experience of any type of emotional violence reported by the respondent'}, {'measure': 'Experience of physical violence, past two weeks', 'timeFrame': '2 weeks prior to the endline survey', 'description': 'A binary variable of self-reported experience of any type of physical violence reported by the respondent'}, {'measure': 'Experience of sexual violence, past school term', 'timeFrame': '~4 months (Term 3 of School Year 2023)', 'description': 'A binary variable of self-reported experience of any type of sexual violence reported by the respondent'}, {'measure': 'Experience of emotional violence, past school term', 'timeFrame': '~4 months (Term 3 of School Year 2023)', 'description': 'A binary variable of self-reported experience of any type of emotional violence reported by the respondent'}, {'measure': 'Experience of physical violence, past school term', 'timeFrame': '~4 months (Term 3 of School Year 2023)', 'description': 'A binary variable of self-reported experience of any type of physical violence reported by the respondent'}, {'measure': 'Attitudes towards gender roles and norms', 'timeFrame': '~4 months post-intervention', 'description': 'a composite score based on 7 items with a likert-scale'}, {'measure': 'Attitudes towards SRGBV', 'timeFrame': '~4 months post-intervention', 'description': 'a composite score based on 7 items with a likert-scale'}, {'measure': 'Attitudes towards reporting SRGBV', 'timeFrame': '~4 months post-intervention', 'description': 'a composite score based on 2 items with a likert-scale'}, {'measure': 'Bystander reporting', 'timeFrame': '~4 months post-intervention', 'description': 'A binary indicator coded to 1 if adolescent reported any case of violence in the past school term (0/1)'}, {'measure': 'Attitudes towards bystander intervention (vignettes)', 'timeFrame': '~4 months post-intervention', 'description': 'A score based on 2 questions on attitudes towards bystander intervention in hypothetical situations'}, {'measure': 'Descriptive norms around bystander intervention (vignettes)', 'timeFrame': '~4 months post-intervention', 'description': 'A score based on 2 questions on descriptive norms'}, {'measure': 'Injunctive norms around bystander intervention (vignettes)', 'timeFrame': '~4 months post-intervention', 'description': 'A score based on 2 questions on injunctive norms'}, {'measure': 'Aspiration - education attainment', 'timeFrame': '~4 months post-intervention', 'description': 'a variable that indicates the level of formal education the respondent would like to complete'}, {'measure': 'Aspiration for a career', 'timeFrame': '~4 months post-intervention', 'description': 'a binary indicator coded to 1 if adolescent aspires for professional career'}, {'measure': 'Perceived social support', 'timeFrame': '~4 months post-intervention', 'description': 'mean score based on the Multidimensional Scale of Perceived Social Support'}, {'measure': 'Anxiety', 'timeFrame': '~4 months post-intervention', 'description': 'a composite score based on GAD-7 anxiety scale (Spitzer et al., 1999)'}, {'measure': 'Perceived safety at school', 'timeFrame': '~4 months post-intervention', 'description': 'A composite score of 5 items about whether respondent feels safe at school'}, {'measure': 'Aspired age of marriage', 'timeFrame': '~4 months post-intervention', 'description': 'a binary indicator coded to 1 if adolescent aspires to marry after the age of 18'}, {'measure': 'Agency', 'timeFrame': '~4 months post-intervention', 'description': 'A composite score based on 20 items that measure different aspects of agency, including freedom of movement, voice, behavioral control and decision making, adapted from the Agency Scale from the Global Early Adolescent Study (Zimmerman et al., 2019)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gender-based Violence']}, 'descriptionModule': {'briefSummary': "The objective of this mixed-methods study is to evaluate the effectiveness of a school-based safe-space program delivered to secondary school students in Zambia. The quantitative component of the study uses a randomized controlled trial to measure changes in students' experience of school-related gender-based violence (SRGBV), attitudes towards gender and SRGBV, socio-emotional well-being, and school climate, among other outcomes. Meanwhile, the qualitative component of the study aims to understand the prevailing norms around SRGBV in schools, the perception of the intervention and its impact, and the potential mechanisms through which the intervention generates its outcomes.", 'detailedDescription': 'This study will evaluate the impact of the Empowerment Pilot, a school-based safe-space program delivered to secondary school students in Zambia, implemented between May and November 2023. The main question it aims to answer is whether the Empowerment Pilot changes attitudes and norms around gender roles and school-related gender-based violence (SRGBV), increases socio-emotional well-being, improves school climate, and reduces SRGBV. We use a mixed-methods triangulation design and combined qualitative and quantitative approaches in data collection and analysis to enhance the validity, depth, and relevance of our findings. Data will be collected from approximately 6,000 adolescent girls and boys and their teachers across three districts in Zambia.\n\nThe mixed-methods evaluation gives equal importance to the qualitative and quantitative components. However, this registration primarily describes the quantitative component of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Adolescent Participants:\n\n* Students enrolled in grades 8 - 11 of secondary schools in the 2023 school year at the start of the intervention'}, 'identificationModule': {'nctId': 'NCT05839457', 'briefTitle': 'Addressing School-related Gender-based Violence as Part of the Keeping Girls in School Initiative in Zambia', 'organization': {'class': 'OTHER', 'fullName': 'World Bank'}, 'officialTitle': 'Safe-space Program in Secondary Schools to Address School-related Gender-based Violence in Zambia: a Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'p151451'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Empowerment Pilot', 'interventionNames': ['Behavioral: Empowerment Pilot']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Empowerment Pilot', 'type': 'BEHAVIORAL', 'description': 'The Empowerment Pilot is a school-based program aimed to raise awareness and change attitudes around SRGBV among students and teachers and promote gender equality. This intervention includes training provided by Teacher Mentors to other teachers in school, learning sessions delivered via safe spaces for student learners, and guidance for engaging parent-teacher committees.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lusaka', 'country': 'Zambia', 'facility': 'secondary schools in Kasama, Mpongwe, and Zambezi districts', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Wei Chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'World Bank'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'World Bank', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Economist', 'investigatorFullName': 'Wei Chang', 'investigatorAffiliation': 'World Bank'}}}}