Early-stage development of a complex, community-based intervention to improve women’s perinatal health in rural communities in India- PRAMH 2
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To determine community attitudes and beliefs around PMH, context, and health services available in Haryana, using our in Telangana adapted situational analysis tool
研究概览
简要总结
The Perinatal Mental Health (PRAMH) Phase 2 study aims to develop a complex intervention to address the significant challenge of preventing, detecting and supporting women with common perinatal mental disorders (CPMDs) in rural India, by integrating mental health into maternity care. Building on the findings from the formative Phase 1 (January 2022 - June 2023), the overall aim of the PRAMH study is to develop a clear theory of change and pathway for future development, implementation, and evaluation.
The research question is: Can a complex, community-based intervention support women with CPMDs in rural India? The study will use mixed methods and a learning health systems approach, working in close partnership with women with lived experience of CPMDs, families, local communities, and key stakeholders, such as policy and non-governmental organisations. The study aims to build a systems approach that identifies and targets perinatal mental health (PMH), stigma and critical social determinants of PMH. Iterative, multi-sectoral collaboration will guide the development of the intervention, training, data collection, and evaluation.
The study will develop a community-based, technology-enabled, task-shifting intervention. Using the community-initiated care approach, the study will: (1) train community health workers to use digital technology to identify women with CPMDs and link community and health care system; (2) train peer-workers to administer the Thinking Healthy Programme in village support groups; (3) develop a community anti-stigma campaign. PRAMH is building on the ongoing, large randomised controlled SMARThealth Pregnancy trial (clinicaltrials.gov NCT05752955) and will be using the SMARThealth platform.
If proven feasible and acceptable, PRAMH can be tested and evaluated in a randomised controlled trial. The intervention has the potential to improve promotion, prevention and treatment for CPMDs in rural India and other LMICs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •All women who are pregnant and one year after birth who are at risk or experience mental health problems (PHQ9 >4; or GAD7 >4; or SIDAS ≥9).
排除标准
- •[4:32 PM] Thout Sudhir Raj women who decline participation; women who plan to move away and not return to the same village in the next 6 months; women who plan to temporarily move away (e.g., to their mother’s village around the time of birth) within the trial period (6 months); women who do not speak and understand verbal communication in the local study language, or girls aged < 18 years of age.
结局指标
主要结局
To determine community attitudes and beliefs around PMH, context, and health services available in Haryana, using our in Telangana adapted situational analysis tool
时间窗: Baseline to 4-6 months of intervention.
To refine our proposed intervention with stakeholders in ToC workshops, clarify pathways to impact, and develop a shared project vision
时间窗: Baseline to 4-6 months of intervention.
次要结局
- To develop a digital screening tool to identify women at risk of CPMDs (“ASHAsâ€)(To develop peer groups to support women during pregnancy and after birth (“Peer groupsâ€))
研究者
Dr D Praveen
George Institute for Global Health