Strengthening the Evidence Base on Effective scHool Based intErventions for pRomoting Adolescent Health (SEHER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29,527
- 试验地点
- 1
- 主要终点
- School Climate
研究概览
简要总结
SEHER Plus- Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent health, seeks to evaluate a school based adolescent health promotion intervention delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM) and lay school counsellor called as SEHER Mitra (SM) in government- run secondary schools in Bihar, India. SEHER Plus will be implemented in the same randomly assigned 74 schools wherein, the SEHER trial (ClinicalTrials.gov ID: NCT02484014)-a three armed clustered randomised trial (CRT) was implemented to evaluate the effectiveness and cost-effectiveness of these two models compared with the Tarang-Adolescence Education Programme (usual care) implemented by the State Government of Bihar.
The SEHER trial hypothesised that both interventions, compared to the control arm, would lead to a greater impact on school climate (school connectedness and relationship with teachers and fellow students). In addition, the interventions would increase the knowledge, attitude and awareness, and promoting healthy behaviours in youth on reproductive and sexual health outcomes, mental health and substance use, and gender related attitudes and violence. The SEHER trial also hypothesized that the addition of more resource intensive component (the SM arm) would be associated with the best outcomes. The hypothesis for the SEHER Plus is that students who will have exposure to the SEHER intervention activities in two academic years (Class IX and X) will show greater benefits on the primary, secondary and exploratory outcomes than students who have exposure to the SEHER intervention activities in one academic year (Class IX).
详细描述
Background and objective: India is home to 358 million young people in the age group of 10 to 24; of these 243 million are between 10 and 19 years age. This represents a huge opportunity that can transform the social and economic fortunes of the country. Key public health challenges for adolescents in India include unwanted pregnancies, sexually transmitted and reproductive tract infections, injuries, growing misuse of alcohol, tobacco and other substances, and mental health problems such as depression, anxiety disorders and suicide. Schools provide an ideal platform for addressing these health issues and the World Health Organization's Health Promoting Schools framework seeks to address some of the structural determinants of these health concerns. The recent Cochrane review assessed school- based interventions and found that 'whole school' or 'school environment' interventions are effective in addressing a range of health outcomes among adolescents including bullying, aggression, and tobacco use. However, there is no comparable evidence on effectiveness and cost-effectiveness on school-based health promotion programmes in India.
Sangath has implemented SEHER-Strengthening Evidence base on school-based intErventions for pRomoting adolescent health (ClinicalTrials.gov ID: NCT02484014) , which is a jointly funded programme (by The MacArthur Foundation and United Nation's Population Development Fund, India) that seeks to develop and evaluate a comprehensive adolescent health promotion intervention delivered by two different delivery agents viz. teacher as SEHER Mitra (TSM) and a lay health worker called as SEHER Mitra (SM) in government run secondary schools in Bihar, India. Following hypotheses are addressed through SEHER trial:
- For primary outcome measure: It is hypothesized that the intervention strategies in addition to usual intervention (Tarang-AEP) will have a graded effect on overall school climate.
- For secondary outcome measures: The interventions will build positive attitude towards gender equity, build knowledge of and attitude towards reproductive and sexual health, reduce self-reported bullying, violence and depression.
- For exploratory outcome measures : The interventions will decrease tobacco, alcohol and other substance use, reduce suicide behaviour (suicide thoughts and attempts) and increase safe sexual behaviour.
Hypotheses for SEHER Plus:
The SEHER Plus will address the additional benefits of providing an exposure to intervention activities for two years versus one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All the students enrolled in class IX in academic year March 2015- April 2016 and enrolled in class IX in academic year March 2016- April 2017 in all the randomly assigned 74 schools will be invited to participate in the study.
排除标准
- 未提供
研究组 & 干预措施
TSM arm
The SEHER intervention will be delivered by a trained teacher, called as Teacher-as-SEHER Mitra (Mitra meaning friend) or lay health worker called as SEHER Mitra being trained to facilitate following activitiesAwareness generation activities for all stakeholders in school; Wall-magazine, Speak-out box, Competitions, School Health Promotion Committee, School health policies, Peer groups of students of class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.
This intervention will be delivered in each school over the academic year.
干预措施: SEHER Intervention delivered by TSM (Behavioral)
TSM arm
The SEHER intervention will be delivered by a trained teacher, called as Teacher-as-SEHER Mitra (Mitra meaning friend) or lay health worker called as SEHER Mitra being trained to facilitate following activitiesAwareness generation activities for all stakeholders in school; Wall-magazine, Speak-out box, Competitions, School Health Promotion Committee, School health policies, Peer groups of students of class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.
This intervention will be delivered in each school over the academic year.
干预措施: Tarang AEP (Behavioral)
SM arm
The SEHER intervention will be delivered by a lay health worker called as SEHER Mitra being trained to facilitate following activities: Awareness generation activities for all stakeholders in school; Wall-magazine, Speak-out box, Competitions, School Health Promotion Committee, School health policies, Peer groups of students of class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.
This intervention will be delivered in each school over the academic year.
干预措施: SEHER Intervention delivered by SM (Behavioral)
SM arm
The SEHER intervention will be delivered by a lay health worker called as SEHER Mitra being trained to facilitate following activities: Awareness generation activities for all stakeholders in school; Wall-magazine, Speak-out box, Competitions, School Health Promotion Committee, School health policies, Peer groups of students of class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.
This intervention will be delivered in each school over the academic year.
干预措施: Tarang AEP (Behavioral)
Comparison arm Tarang AEP
The comparison arm involves 'usual care' which in the study setting is the Tarang: Adolescence Education Programme comprising of 16 classroom sessions on process of growing-up, prevention of HIV/AIDS and other Sexually Transmitted Diseases (STDs), and prevention of substance and other drug abuse. This programme is delivered by a trained nodal teacher in the school over the academic year.
干预措施: Tarang AEP (Behavioral)
结局指标
主要结局
School Climate
时间窗: Up to 7 months
The school climate will be measured through Beyond Blue School Climate Scale (28 items)
次要结局
- Knowledge and attitude towards Reproductive and Sexual Health(Up to 7 months)
- Self-reported bully behaviour(Up to 7 months)
- Attitude towards gender equity(Up to 7 months)
- self-reported violence(Up to 7 months)
- Depression(Up to 7 months)