A Longitudinal Mixed Method Evaluation of the No Means No Intervention for Violence Prevention in Gqeberha, South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,173
- 试验地点
- 1
- 主要终点
- Change in reported sexual violence exposure incidence, intervention vs. control
研究概览
简要总结
This school-based study will evaluate a behavioral intervention-the No Means No (NMN) intervention-to reduce violence among enrolled girls, ages 10-19, through a cluster-randomized control trial and a nested qualitative study.
详细描述
This protocol describes a mixed method evaluation study of a behavioral intervention-the No Means No (NMN) intervention-to reduce violence among enrolled girls, ages 10-19.
The No Means No intervention is an 8-12-hour behavioral intervention designed to teach Empowerment Self-Defense (ESD) to girls. A parallel intervention with boys focuses on violence perpetration by addressing issues of consent and bystander intervention. The intervention also includes a network of referrals.
The intervention will be evaluated through a cluster-randomized, controlled trial and a nested qualitative study. Implementation sites such as schools and afterschool programs (hereafter collectively referred to as schools) will be randomized to receive the girls' intervention only, the girls' and boys' interventions in parallel, or the control condition (standard of care). Control arm schools will receive the intervention as is following the study period if proven safe and effective. The study will enroll a subset of intervention participants (ages 10-19 years inclusive) at each intervention school, and an equal number of girls and boys at each control school. Experience and perpetration of sexual violence (SV), other forms of intimate partner violence (IPV), and community violence (CV) will be compared across the study arms over time, as well as engagement with referral services. At any timepoint when violence is disclosed, participants will receive first-line support and referrals for care. Participants will be followed longitudinally for 12 months.
Population: Approximately 2250 girls and 1000 boys, aged 10 to 19 years of age (inclusive) who are enrolled in 15 schools. Boys will be enrolled from the schools randomized to receive the boys' intervention and the control schools only.
Study Site(s): NMNW Implementation Site, Gqeberha, South Africa
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 10-19
- •Enrolled in a selected school or afterschool program in the Nelson Mandela Bay municipality
- •Not planning to move, de-enroll, or graduate during the study period
- •Willing to participate in the 6 session No Means No intervention
- •Able and willing to provide written informed consent or assent and parental consent if under 18
- •English, isiXhosa, or Afrikaans speaking
排除标准
- •° Has any significant medical condition or other condition that, in the opinion of the Principal Investigator (PI)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
结局指标
主要结局
Change in reported sexual violence exposure incidence, intervention vs. control
时间窗: Measured at baseline, six months and one year from enrollment
Change in female participants self-report of sexual violence experience measured using adapted questions from the Manhood 2.0 study, assessed in the combined intervention arms vs. the control arm
Change in intervention mechanisms of action
时间窗: Measured at three months and one year from enrollment
Qualitative assessment of changes in theorized mechanisms of action, e.g. ways in which the intervention impacts sexual violence, explored over time using open-ended questions.
次要结局
- Change in reported intimate partner violence exposure incidence(Measured at baseline, six months and one year from enrollment)
- Change in reported community violence exposure incidence(Measured at baseline, six months and one year from enrollment)
- Change in reported sexual violence exposure incidence(Measured at baseline, six months and one year from enrollment)
- Change in knowledge of sexual violence and prevention strategies(Measured at baseline, three months, six months, and one year from enrollment)
- Change in attitudes towards violence(Measured at baseline, three months, six months, and one year from enrollment)
- Change in sexual violence perpetration(Measured at baseline, six months and one year from enrollment)
- Change in gender norms(Measured at baseline, three months, six months, and one year from enrollment)
- Change in use of intervention behaviors(Measured at baseline, three months, six months, and one year from enrollment)
研究者
Miriam Hartmann
Principal Investigator
RTI International