Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT06208293
Brief Summary:
Investigators will conduct a pilot clinical trial to assess the feasibility and acceptability of implementing a Suicide Prevention Package (SuPP) within an existing task-shifted depression intervention in rural Pakistan. This pilot research lays the groundwork for a future project to scale a package for multi-level suicide prevention strategies that can be integrated into community based mental health programs, particularly targeting individuals living in low-resourced settings. As the model is designed to be easily adapted and integrated, investigators anticipate the findings will be valuable for all researchers looking to improve population health and mental health services in disadvantaged settings.
Detailed Description:
The proposed research will (1) examine the epidemiology and health impacts of recurrent suicidal ideation on mothers over time, (2) characterize key features of suicidal ideation and finalize intervention package components within the study context, and (3) conduct a pilot clinical trial to assess the feasibility and acceptability of implementing a Suicide Prevention Package (SuPP) within an existing task-shifted depression intervention in rural Pakistan. This pilot research lays the groundwork for a future project to scale a package for multi-level suicide prevention strategies that can be integrated into community based mental health programs, particularly targeting individuals living in low-resourced settings. As the model is designed to be easily adapted and integrated, we anticipate the findings will be valuable for all researchers looking to improve population health and mental health services in disadvantaged settings. The focus of this registration is the pilot clinical trial.
A stratified cluster randomized controlled trial design, with 6 village clusters allocated in a 1:1 ratio to the intervention and control arms will be used. The stratification will be level of the Union Council (which is the smallest district administrative unit) and include Sihala and Shah Allah Ditta. While a village cluster (VC) will be the unit of randomization. Each VC will have 900-1400 population of women of reproductive age based within two to three contiguous catchment areas of the government employed community health workers called Lady Health Workers (LHWs). The reason for choosing village cluster as the unit of randomization is to minimize contamination/spillage between trial participants as the intervention will be delivered within community-based households. The intervention (KPZ) and control (EUC) village clusters will be geographically separated and the chance of intervention cluster participants regularly meeting control cluster participants will be negligible.
Study:
NCT06208293
Study Brief:
Protocol Section:
NCT06208293