- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05839457
Addressing School-related Gender-based Violence as Part of the Keeping Girls in School Initiative in Zambia
Safe-space Program in Secondary Schools to Address School-related Gender-based Violence in Zambia: a Cluster Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
The mixed-methods evaluation gives equal importance to the qualitative and quantitative components. However, this registration primarily describes the quantitative component of the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Frank Kakungu
- Phone Number: 0967907362
- Email: kakungu@zamstats.gov.zm
Study Locations
-
-
-
Lusaka, Zambia
- Recruiting
- secondary schools in Kasama, Mpongwe, and Zambezi districts
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for Adolescent Participants:
- Students enrolled in grades 8 - 11 of secondary schools in the 2023 school year at the start of the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
|
|
Experimental: Intervention group
Empowerment Pilot
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experience of any SRGBV, past two weeks
Time Frame: two weeks prior to the endline survey
|
A binary variable of self-reported experience of any SRGBV in the past two weeks
|
two weeks prior to the endline survey
|
Experience of any SRGBV, past school term
Time Frame: ~4 months (Term 3 of School Year 2023)
|
A binary variable of self-reported experience of any SRGBV in the past school term
|
~4 months (Term 3 of School Year 2023)
|
Attitudes towards gender roles and SRGBV (adolescents)
Time Frame: ~4 months post-intervention
|
A normalized index based on 16 items that measure attitudes towards gender roles, SRGBV, and support to victims
|
~4 months post-intervention
|
School climate
Time Frame: ~4 months post-intervention
|
A composite score based on 16 statements about aspects of school climate and student-teacher interactions
|
~4 months post-intervention
|
Socio-emotional well-being
Time Frame: ~4 months post-intervention
|
A normalized index based on 3 scales related to subjective well-being: perceived social support; perceived safety; and anxiety.
|
~4 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge of SRGBV
Time Frame: ~4 months post-intervention
|
the fraction of correct responses to 12 questions that ask whether an act is considered violence
|
~4 months post-intervention
|
School absenteeism
Time Frame: one month prior to the endline survey
|
number of days an adolescent missed in the last completed month
|
one month prior to the endline survey
|
School enrollment
Time Frame: ~4 months post-intervention
|
A binary indicator for school enrollment status
|
~4 months post-intervention
|
General self-efficacy
Time Frame: ~4 months post-intervention
|
a composite score of 10 items on the General self-efficacy scale.
|
~4 months post-intervention
|
Assertive communication
Time Frame: ~4 months post-intervention
|
a composite score of 6 items on the Assertiveness Communication scale
|
~4 months post-intervention
|
Gender equitable injunctive norms
Time Frame: ~4 months post-intervention
|
A composite score of injunctive norms for gender equality norms, GBV, Corporal punishment, and GBV reporting
|
~4 months post-intervention
|
Gender equitable descriptive norms
Time Frame: ~4 months post-intervention
|
A composite score of descriptive norms for gender equality, GBV, Corporal punishment, and GBV reporting
|
~4 months post-intervention
|
Experience of sexual violence, past two weeks
Time Frame: 2 weeks prior to the endline survey
|
composite scores based on the frequency of different types of sexual violence reported by the respondent
|
2 weeks prior to the endline survey
|
Experience of emotional violence, past two weeks
Time Frame: 2 weeks prior to the endline survey
|
composite scores based on the frequency of different types of emotional violence reported by the respondent
|
2 weeks prior to the endline survey
|
Experience of physical violence, past two weeks
Time Frame: 2 weeks prior to the endline survey
|
composite scores based on the frequency of different types of physical violence reported by the respondent
|
2 weeks prior to the endline survey
|
Experience of sexual violence, past school term
Time Frame: ~4 months (Term 3 of School Year 2023)
|
composite scores based on the frequency of different types of sexual violence reported by the respondent
|
~4 months (Term 3 of School Year 2023)
|
Experience of emotional violence, past school term
Time Frame: ~4 months (Term 3 of School Year 2023)
|
composite scores based on the frequency of different types of emotional violence reported by the respondent
|
~4 months (Term 3 of School Year 2023)
|
Experience of physical violence, past school term
Time Frame: ~4 months (Term 3 of School Year 2023)
|
composite scores based on the frequency of different types of physical violence reported by the respondent
|
~4 months (Term 3 of School Year 2023)
|
Attitudes towards gender roles and norms
Time Frame: ~4 months post-intervention
|
a composite score based on 7 items with a likert-scale
|
~4 months post-intervention
|
Attitudes towards SRGBV
Time Frame: ~4 months post-intervention
|
a composite score based on 7 items with a likert-scale
|
~4 months post-intervention
|
Attitudes towards reporting SRGBV
Time Frame: ~4 months post-intervention
|
a composite score based on 2 items with a likert-scale
|
~4 months post-intervention
|
Bystander reporting
Time Frame: ~4 months post-intervention
|
A binary indicator coded to 1 if adolescent reported any case of violence in the past school term (0/1)
|
~4 months post-intervention
|
Attitudes towards bystander intervention (vignettes)
Time Frame: ~4 months post-intervention
|
A score based on 2 questions on attitudes towards bystander intervention in hypothetical situations
|
~4 months post-intervention
|
Descriptive norms around bystander intervention (vignettes)
Time Frame: ~4 months post-intervention
|
A score based on 2 questions on descriptive norms
|
~4 months post-intervention
|
Injunctive norms around bystander intervention (vignettes)
Time Frame: ~4 months post-intervention
|
A score based on 2 questions on injunctive norms
|
~4 months post-intervention
|
Aspiration - education attainment
Time Frame: ~4 months post-intervention
|
a variable that indicates the level of formal education the respondent would like to complete
|
~4 months post-intervention
|
Aspiration for a career
Time Frame: ~4 months post-intervention
|
a binary indicator coded to 1 if adolescent aspires for professional career
|
~4 months post-intervention
|
Perceived social support
Time Frame: ~4 months post-intervention
|
mean score based on the Multidimensional Scale of Perceived Social Support
|
~4 months post-intervention
|
Anxiety
Time Frame: ~4 months post-intervention
|
a composite score based on GAD-7 anxiety scale (Spitzer et al., 1999)
|
~4 months post-intervention
|
Perceived safety at school
Time Frame: ~4 months post-intervention
|
A composite score of 5 items about whether respondent feels safe at school
|
~4 months post-intervention
|
Aspired age of marriage
Time Frame: ~4 months post-intervention
|
a binary indicator coded to 1 if adolescent aspires to marry after the age of 18
|
~4 months post-intervention
|
Agency
Time Frame: ~4 months post-intervention
|
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)
|
~4 months post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Teachers' knowledge of SRGBV
Time Frame: ~4 months post-intervention
|
the fraction of correct responses to 12 questions that ask whether an act is considered violence
|
~4 months post-intervention
|
Teachers' assessment of school climate
Time Frame: ~4 months post-intervention
|
An index based on 17 items that measure to what extent the school climate is safe for both boys and girls
|
~4 months post-intervention
|
Attitudes towards gender roles and SRGBV (teachers)
Time Frame: ~4 months post-intervention
|
A normalized index based on 16 items that measure attitudes towards gender roles, SRGBV, and support to victims
|
~4 months post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wei Chang, World Bank
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- p151451
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Gender-based Violence
-
RTI InternationalNo Means No WorldwideCompleted
-
University of SheffieldUniversity of HuddersfieldCompleted
-
University of CalgaryPublic Health Agency of Canada (PHAC)Recruiting
-
Johns Hopkins Bloomberg School of Public HealthUjamaa AfricaRecruitingViolence, Domestic | Violence, Sexual | Violence, Gender-BasedKenya
-
Johns Hopkins UniversityCompleted
-
Emory UniversityCompletedIntimate Partner Violence | Gender Based ViolenceColombia
-
JhpiegoCompletedIntimate Partner Violence | Gender-based Violence | Reproductive CoercionNigeria
-
Universidad de GranadaOdense University Hospital; University of Southern DenmarkCompletedPregnancy Related | Intimate Partner Violence | Violence, Gender-BasedDenmark, Spain
-
Johns Hopkins UniversityNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingViolence, Domestic | Violence | Violence, Sexual | Violence, Physical | Violence, Gender-Based | Violence-Related SymptomUnited States
-
RTI InternationalEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
Clinical Trials on Empowerment Pilot
-
Azienda Per I Servizi Sanitari N. 2 IsontinaAzienda per i servizi Sanitari 4 Medio Friuli, Dipartimento di Salute Mentale... and other collaboratorsCompletedObesity | Overweight | Power, PersonalItaly
-
Center for Hunger-Free CommunitiesCompletedChild Development | Hunger | Social IsolationUnited States
-
Fakeeh College for Medical SciencesCompleted
-
Macmillan Research Group UKCompletedAbuse Physical Battered Woman SyndromeIndia
-
University of California, BerkeleyThe Robertson FoundationUnknownTo Better Understand How Epicenter's (Which House Education, Health and Finance Centers in Ghana) Increase Individual's Sense of Empowerment.Ghana
-
National Institute of Diabetes and Digestive and...CompletedHypertension | Diabetes
-
Radboud University Medical CenterCompleted
-
Tzu-Ting HuangCompleted
-
Nova Scotia Health AuthorityRecruiting