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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05839457
Other study ID # p151451
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 8, 2023
Est. completion date May 31, 2024

Study information

Verified date April 2024
Source World Bank
Contact Frank Kakungu
Phone 0967907362
Email kakungu@zamstats.gov.zm
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 (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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6000
Est. completion date May 31, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Zambia secondary schools in Kasama, Mpongwe, and Zambezi districts Lusaka

Sponsors (1)

Lead Sponsor Collaborator
World Bank

Country where clinical trial is conducted

Zambia, 

Outcome

Type Measure Description Time frame Safety issue
Other Teachers' knowledge of SRGBV the fraction of correct responses to 12 questions that ask whether an act is considered violence ~4 months post-intervention
Other Teachers' assessment of school climate 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
Other Attitudes towards gender roles and SRGBV (teachers) A normalized index based on 16 items that measure attitudes towards gender roles, SRGBV, and support to victims ~4 months post-intervention
Primary Experience of any SRGBV, past two weeks A binary variable of self-reported experience of any SRGBV in the past two weeks two weeks prior to the endline survey
Primary Experience of any SRGBV, past school term A binary variable of self-reported experience of any SRGBV in the past school term ~4 months (Term 3 of School Year 2023)
Primary 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 ~4 months post-intervention
Primary School climate A composite score based on 16 statements about aspects of school climate and student-teacher interactions ~4 months post-intervention
Primary Socio-emotional well-being A normalized index based on 3 scales related to subjective well-being: perceived social support; perceived safety; and anxiety. ~4 months post-intervention
Secondary Knowledge of SRGBV the fraction of correct responses to 12 questions that ask whether an act is considered violence ~4 months post-intervention
Secondary School absenteeism number of days an adolescent missed in the last completed month one month prior to the endline survey
Secondary School enrollment A binary indicator for school enrollment status ~4 months post-intervention
Secondary General self-efficacy a composite score of 10 items on the General self-efficacy scale. ~4 months post-intervention
Secondary Assertive communication a composite score of 6 items on the Assertiveness Communication scale ~4 months post-intervention
Secondary Gender equitable injunctive norms A composite score of injunctive norms for gender equality norms, GBV, Corporal punishment, and GBV reporting ~4 months post-intervention
Secondary Gender equitable descriptive norms A composite score of descriptive norms for gender equality, GBV, Corporal punishment, and GBV reporting ~4 months post-intervention
Secondary Experience of sexual violence, past two weeks composite scores based on the frequency of different types of sexual violence reported by the respondent 2 weeks prior to the endline survey
Secondary Experience of emotional violence, past two weeks composite scores based on the frequency of different types of emotional violence reported by the respondent 2 weeks prior to the endline survey
Secondary Experience of physical violence, past two weeks composite scores based on the frequency of different types of physical violence reported by the respondent 2 weeks prior to the endline survey
Secondary Experience of sexual violence, past school term composite scores based on the frequency of different types of sexual violence reported by the respondent ~4 months (Term 3 of School Year 2023)
Secondary Experience of emotional violence, past school term composite scores based on the frequency of different types of emotional violence reported by the respondent ~4 months (Term 3 of School Year 2023)
Secondary Experience of physical violence, past school term composite scores based on the frequency of different types of physical violence reported by the respondent ~4 months (Term 3 of School Year 2023)
Secondary Attitudes towards gender roles and norms a composite score based on 7 items with a likert-scale ~4 months post-intervention
Secondary Attitudes towards SRGBV a composite score based on 7 items with a likert-scale ~4 months post-intervention
Secondary Attitudes towards reporting SRGBV a composite score based on 2 items with a likert-scale ~4 months post-intervention
Secondary Bystander reporting A binary indicator coded to 1 if adolescent reported any case of violence in the past school term (0/1) ~4 months post-intervention
Secondary Attitudes towards bystander intervention (vignettes) A score based on 2 questions on attitudes towards bystander intervention in hypothetical situations ~4 months post-intervention
Secondary Descriptive norms around bystander intervention (vignettes) A score based on 2 questions on descriptive norms ~4 months post-intervention
Secondary Injunctive norms around bystander intervention (vignettes) A score based on 2 questions on injunctive norms ~4 months post-intervention
Secondary Aspiration - education attainment a variable that indicates the level of formal education the respondent would like to complete ~4 months post-intervention
Secondary Aspiration for a career a binary indicator coded to 1 if adolescent aspires for professional career ~4 months post-intervention
Secondary Perceived social support mean score based on the Multidimensional Scale of Perceived Social Support ~4 months post-intervention
Secondary Anxiety a composite score based on GAD-7 anxiety scale (Spitzer et al., 1999) ~4 months post-intervention
Secondary Perceived safety at school A composite score of 5 items about whether respondent feels safe at school ~4 months post-intervention
Secondary Aspired age of marriage a binary indicator coded to 1 if adolescent aspires to marry after the age of 18 ~4 months post-intervention
Secondary 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) ~4 months post-intervention
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