Gender-based ViolenceNCT05839457
Addressing School-related Gender-based Violence as Part of the Keeping Girls in School Initiative in Zambia
A study testing Empowerment Pilot in people with Gender-based Violence, run by World Bank at 1 site in Zambia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gender-based Violence
- What is being tested?
- Empowerment Pilot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteZambia
- Study dates
- 8 May 2023to 7 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students enrolled in grades 8 - 11 of secondary schools in the 2023 school year at the start of the intervention
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Zambia1 site
secondary schools in Kasama, Mpongwe, and Zambezi districts
Lusaka
About this study
Official title: Safe-space Program in Secondary Schools to Address School-related Gender-based Violence in Zambia: a Cluster Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Gender-based Violence
- Being tested
- Empowerment Pilot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment PilotBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Empowerment Pilot Receives: Behavioral: Empowerment Pilot |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of any SRGBV, past two weeks
A binary variable of self-reported experience of any SRGBV in the past two weeks
Measured: two weeks prior to the endline survey
Experience of any SRGBV, past school term
A binary variable of self-reported experience of any SRGBV in the past school term
Measured: ~4 months (Term 3 of School Year 2023)
Attitudes towards gender roles and SRGBV (adolescents)
A normalized index based on 16 items that measure attitudes towards gender roles, SRGBV, and support to victims
Measured: ~4 months post-intervention
School climate
A composite score based on 16 statements about aspects of school climate and student-teacher interactions
Measured: ~4 months post-intervention
Socio-emotional well-being
A normalized index based on 3 scales related to subjective well-being: perceived social support; perceived safety; and anxiety.
Measured: ~4 months post-intervention
Secondary outcomes (27)
Knowledge of SRGBV
the fraction of correct responses to 12 questions that ask whether an act is considered violence
Measured: ~4 months post-intervention
School absenteeism
number of days an adolescent missed in the last completed month
Measured: one month prior to the endline survey
School enrollment
A binary indicator for school enrollment status
Measured: ~4 months post-intervention
General self-efficacy
a composite score of 10 items on the General self-efficacy scale.
Measured: ~4 months post-intervention
Assertive communication
a composite score of 6 items on the Assertiveness Communication scale
Measured: ~4 months post-intervention
Gender equitable injunctive norms
A composite score of injunctive norms for gender equality norms, GBV, Corporal punishment, and GBV reporting
Measured: ~4 months post-intervention
Gender equitable descriptive norms
A composite score of descriptive norms for gender equality, GBV, Corporal punishment, and GBV reporting
Measured: ~4 months post-intervention
Experience of sexual violence, past two weeks
A binary variable of self-reported experience of any type of sexual violence reported by the respondent
Measured: 2 weeks prior to the endline survey
Experience of emotional violence, past two weeks
A binary variable of self-reported experience of any type of emotional violence reported by the respondent
Measured: 2 weeks prior to the endline survey
Experience of physical violence, past two weeks
A binary variable of self-reported experience of any type of physical violence reported by the respondent
Measured: 2 weeks prior to the endline survey
Experience of sexual violence, past school term
A binary variable of self-reported experience of any type of sexual violence reported by the respondent
Measured: ~4 months (Term 3 of School Year 2023)
Experience of emotional violence, past school term
A binary variable of self-reported experience of any type of emotional violence reported by the respondent
Measured: ~4 months (Term 3 of School Year 2023)
Experience of physical violence, past school term
A binary variable of self-reported experience of any type of physical violence reported by the respondent
Measured: ~4 months (Term 3 of School Year 2023)
Attitudes towards gender roles and norms
a composite score based on 7 items with a likert-scale
Measured: ~4 months post-intervention
Attitudes towards SRGBV
a composite score based on 7 items with a likert-scale
Measured: ~4 months post-intervention
Attitudes towards reporting SRGBV
a composite score based on 2 items with a likert-scale
Measured: ~4 months post-intervention
Bystander reporting
A binary indicator coded to 1 if adolescent reported any case of violence in the past school term (0/1)
Measured: ~4 months post-intervention
Attitudes towards bystander intervention (vignettes)
A score based on 2 questions on attitudes towards bystander intervention in hypothetical situations
Measured: ~4 months post-intervention
Descriptive norms around bystander intervention (vignettes)
A score based on 2 questions on descriptive norms
Measured: ~4 months post-intervention
Injunctive norms around bystander intervention (vignettes)
A score based on 2 questions on injunctive norms
Measured: ~4 months post-intervention
Aspiration - education attainment
a variable that indicates the level of formal education the respondent would like to complete
Measured: ~4 months post-intervention
Aspiration for a career
a binary indicator coded to 1 if adolescent aspires for professional career
Measured: ~4 months post-intervention
Perceived social support
mean score based on the Multidimensional Scale of Perceived Social Support
Measured: ~4 months post-intervention
Anxiety
a composite score based on GAD-7 anxiety scale (Spitzer et al., 1999)
Measured: ~4 months post-intervention
Perceived safety at school
A composite score of 5 items about whether respondent feels safe at school
Measured: ~4 months post-intervention
Aspired age of marriage
a binary indicator coded to 1 if adolescent aspires to marry after the age of 18
Measured: ~4 months post-intervention
Agency
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)
Measured: ~4 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start8 May 2023
- Primary completion7 Apr 2024
- Study completion7 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender-based ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Bank
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Chang, World Bank
- Investigators
- Wei Chang, Principal investigator, World Bank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839457
- Sponsor's protocol ID
- p151451
- Status last verified
- Jul 2024
- First submitted
- 16 Mar 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe-space Program in Secondary Schools to Address School-related Gender-based Violence in Zambia: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05839457
- Acronym / sponsor ID
- p151451
- Conditions
- Gender-based Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- World BankUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 7 Apr 2024 (actual)
- Study completion
- 7 Apr 2024 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Empowerment PilotEmpowerment Pilot |
| Control group | No intervention | – |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Students enrolled in grades 8 - 11 of secondary schools in the 2023 school year at the start of the intervention
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment PilotThe 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. | Behavioural | Intervention group |
Primary outcome
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
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
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
School climate
Time frame: ~4 months post-intervention
A composite score based on 16 statements about aspects of school climate and student-teacher interactions
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.
27 secondary outcomes
Knowledge of SRGBV
Time frame: ~4 months post-intervention
School absenteeism
Time frame: one month prior to the endline survey
School enrollment
Time frame: ~4 months post-intervention
General self-efficacy
Time frame: ~4 months post-intervention
Assertive communication
Time frame: ~4 months post-intervention
Gender equitable injunctive norms
Time frame: ~4 months post-intervention
Gender equitable descriptive norms
Time frame: ~4 months post-intervention
Experience of sexual violence, past two weeks
Time frame: 2 weeks prior to the endline survey
Experience of emotional violence, past two weeks
Time frame: 2 weeks prior to the endline survey
Experience of physical violence, past two weeks
Time frame: 2 weeks prior to the endline survey
Experience of sexual violence, past school term
Time frame: ~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)
Experience of physical violence, past school term
Time frame: ~4 months (Term 3 of School Year 2023)
Attitudes towards gender roles and norms
Time frame: ~4 months post-intervention
Attitudes towards SRGBV
Time frame: ~4 months post-intervention
Attitudes towards reporting SRGBV
Time frame: ~4 months post-intervention
Bystander reporting
Time frame: ~4 months post-intervention
Attitudes towards bystander intervention (vignettes)
Time frame: ~4 months post-intervention
Descriptive norms around bystander intervention (vignettes)
Time frame: ~4 months post-intervention
Injunctive norms around bystander intervention (vignettes)
Time frame: ~4 months post-intervention
Aspiration - education attainment
Time frame: ~4 months post-intervention
Aspiration for a career
Time frame: ~4 months post-intervention
Perceived social support
Time frame: ~4 months post-intervention
Anxiety
Time frame: ~4 months post-intervention
Perceived safety at school
Time frame: ~4 months post-intervention
Aspired age of marriage
Time frame: ~4 months post-intervention
Agency
Time frame: ~4 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Chang principal investigator
World Bank
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment Pilot in people with Gender-based Violence, run by World Bank at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of any SRGBV, past two weeks (time frame: two weeks prior to the endline survey). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.