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Набор по приглашению NCT06598553

What Works to Prevent Violence Against Women and Girls in Madagascar

Без фазы С лечением Comprehensive Sexual Education

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Projet Jeune Leader Comprehensive Sexual Education.
Кому может быть актуально
Состояния в реестре: Comprehensive Sexual Education. Базовые параметры: от 10 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Madagascar
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

What Works to Prevent Violence Against Women and Girls in Madagascar: Evaluation of Projet Jeune Leaders Comprehensive Sexual Education Curriculum in Rural Middle Schools

Обзор

The study will evaluate a comprehensive sexual education program (CSE) delivered by Projet Jeune Leader (PJL), a women-led non-governmental program in Madagascar. The study will randomize 50 rural middle schools (grades 6-9), to either intervention (n=25) and control (n=25) schools. The CSE program will be implemented in the 25 intervention middle schools over the course of the school year (Sept-May) by trained PJL educators. Trained research assistants will conduct individual surveys at the beginning of the school year (baseline) and at the end of the school year (endline) with all students (ages 10-older) in both intervention and control schools. All student must have parental permission and provide informed consent to participate in the study, The surveys will include questions on demographics (e.g. age, sex/gender, grade, living situation), self-efficacy, bullying, physical abuse/violence, sexual harassment, sexual abuse and violence, harsh discipline at school and at home, gender/social norms, mental health and sexual and reproductive health. Teachers/school directors will also participate in the surveys, completing surveys at the beginning and end of the school year. The teacher/directors surveys will focus on health and safety of the students and school environment. In addition to the surveys, trained research assistants will conduct midline and endline qualitative interviews with a subsample of students, teachers and directors in the intervention schools to further explore the CSE intervention and impact on health and safety for students and teachers/directors.

Подробное описание

Projet Jeune Leader (PJL) - a southern-based, youth-founded, women-led, women's rights organization - has mainstreamed gender-transformative comprehensive sexuality education (CSE) in Madagascar's public schools. PJL's mission is to improve adolescent learning and well-being - especially in rural and under-served communities. Comprehensive sexuality education (CSE) plays an important role in transforming harmful gender norms and reducing the risk of violence. As an evidence- and curriculum-based intervention, CSE supports youth in developing knowledge, attitudes, skills, intentions, and behaviors for safe, healthy, and gender equitable relationships. PJL's CSE intervention, in particular, has been shown to improve young and very young adolescent students' knowledge, attitudes, self-efficacy, and behavioral intentions toward sexual and reproductive health and rights and gender equality using pre-post school year evidence with comparison schools (Projet Jeune Leader impact summary, 2024). Community-engaged participatory research using Human-centered design (HCD) tools has also revealed that the intervention is impacting aspects of human development which can underpin violence prevention and response, including but not limited to increasing students' courage and confidence, enhancing student-teacher relationships, strengthening family relationships, providing role models in the community, and facilitating the fight against drugs and violence in the community.

Through a formal partnership signed May 2022, Madagascar's National Ministry of Education has committed to institutionalize PJL's model into the education system to reach all schools, especially those that serve the 80% of Madagascar's population living in rural areas. PJL's multi-level partnership with Madagascar's Ministry of Education is unique, and PJL is well-positioned to implement action-oriented research to examine the effect of their CSE intervention on key outcomes of young adolescent victimization and/or perpetration of bullying and violence, and knowledge, attitudes and self-efficacy on violence, gender equality, strengths and difficulties (mental health) and sexual and reproductive health. PJL will also explore the CSE intervention's indirect effects on young adolescent school outcomes (retention, progression) and "safe school environment." Further, CSE implementation reach, implementation, adoption and maintenance with participating middle schools.

The evaluation of the PJL CSE intervention will be conducted through a collaboration between Johns Hopkins University and PJL.The study will use a hybrid type 2 effectiveness-implementation design guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. School-based surveys will be used to measure outcomes at baseline (beginning of school year) and endline (end of school year, 9 months post baseline) with adolescents in 6th-9th grades, teachers and directors at middle schools randomized to either intervention or control schools in targeted rural areas. In addition, quantitative and qualitative methods at midline and endline will be used to measure CSE intervention reach, adoption, implementation and maintenance in intervention middle schools.

Вмешательства

  • Поведенческое Projet Jeune Leader Comprehensive Sexual Education
    PJL provides trained educators to deliver a 22 week comprehensive sexual education (CSE) curriculum in participating middle schools. All adolescents enrolled in the school receive the CSE program.

Первичные конечные точки

  • Peer-to-peer violence victimization [Срок оценки: Baseline, Post-baseline 9 months]
  • Bullying [Срок оценки: Baseline, Post-baseline 9 months]
  • Dating violence [Срок оценки: Baseline, Post-baseline 9 months]
  • Harsh discipline in school [Срок оценки: Baseline, Post-baseline 9 months]
Вторичные конечные точки (6)
  • Sexual health confidence [Срок оценки: Baseline, Post-baseline 9 months]
  • Gender equality [Срок оценки: Baseline, Post-baseline 9 months]
  • Attitudes about dating violence/partner violence [Срок оценки: Baseline, Post-baseline 9 months]
  • Self-confidence [Срок оценки: Baseline, Post-baseline 9 months]
  • Attitudes about healthy relationships [Срок оценки: Baseline, Post-baseline 9 months]
  • Mental Health (Strengths and Difficulties) [Срок оценки: Baseline, Post-baseline 9 months]

Критерии участия

Критерии включения

  • Age 10 years or older
  • Adolescents enrolled in grades 6th-9th in participating intervention and control middle schools in targeted districts
  • Teachers and Directors in intervention and control middle schools in targeted districts
  • Parent and adolescent provide Informed consent
  • Teacher/director provides informed consent

Критерии исключения

  • Less than 10 years old
  • Not a student intervention or control middle schools
  • Not a teacher/director at intervention or control middle schools
  • No informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Madagascar · 1 центр
  • Projet Jeune Leader — Fiananransoa

Идентификаторы

NCT: NCT06598553 · IRB00452498

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗