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临床试验/NCT04125251
NCT04125251已完成不适用

Supporting Women and Girls in Pakistan: Scaling Up Empowerment and Care Strategies to Address Health and Survival

Aga Khan University2 个研究点 分布在 1 个国家目标入组 1,696 人开始时间: 2019年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,696
试验地点
2
主要终点
Improved General Self-Efficacy

研究概览

简要总结

This project aims to offer Life Skills Building (LSB) intervention to Benazir Income Support Program (BISP) Cash Transfer (CT) beneficiaries in couples in order to reduce domestic violence and depression and improve women empowerment in married women of reproductive age. The intervention will be carried out in the rural settlements of district Thatta, Sindh Pakistan.

详细描述

The study will assess the impact of Life Skill Building (LSB) to Benazir Income support Program (BISP) Cash Transfer (CT) beneficiaries and their husbands in improving maternal mental and child health and its combined effect in empowering women and couples. The Formative phase of the project was dedicated for the development and modification of National level LSB curriculum for men and women. The formative phase was carried out in Thatta (Sindh), Rahimyar Khan (Punjab), Lasbela (Baluchistan) and Peshawar (KPK).

The intervention phase will be conducted in district Thatta, where BISP beneficiaries along with their spouses will be offered a LSB training. This intervention will be offered by community teachers to ensure sustainability and community trust. The participants will be recruited for baseline assessment followed by a comprehensive LSB intervention.The end-line follow up assessments (five months of intervention) will be done after the deliver of intervention. A qualitative summative inquiry will be done at the completion of the project to explore the overall impact of the LSB intervention. Since the project is being implemented with the BISP, the cost of intervention can be estimated for the scalability and sustainability.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The participants, LSB providers and the outcomes assessors will not be having knowledge regarding the outcomes being assessed.

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adult married couples living together: where women receive Benazir Income Support Program (BISP) Cash Transfer (CT), have one child of at least 18 months and have no family migration plan for next 2 years

排除标准

  • Gross mental impairment in either of the partners
  • Either of the partner is physically challenged or bedridden

结局指标

主要结局

Improved General Self-Efficacy

时间窗: Base-line, and End-line (5 months post-intervention)

The General Self-Efficacy Scale (GSE) is a 10-item instrument to assess a general sense of perceived self-efficacy with the aim to predict coping and adaptation after stressful life events. Responses to each item are made on a 4-point scale: 1=Not at all true, 2=Hardly true, 3=moderately true, 4=exactly true. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

Decreased Maternal Depression

时间窗: Base-line, and End-line (5 months post-intervention)

The Patient Health Questionnaire (PHQ) is a self-administered instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day), over the last two weeks. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively.

Decreased Domestic Violence

时间窗: Base-line, and End-line (5 months post-intervention)

The revised conflict tactics scale (CTS) consists of 20-item and is self-administered. The scale includes items regarding Negotiation (1-4), Psychological aggression (5-8), Physical assault (9-12), Sexual coercion (13-16) and Injury (17-20). The scoring criteria consists of a scale from 1-8, 1-6 indicates the frequency of conflict happened in the past year ranging from once to more than 20 times. 7 indicates conflict happened not in the past year but happened before that. If it never happened, 8 will be marked. There are many ways to score the CTS: Respondents who reported being a victim of or perpetrating an item or items (Prevalence). The number of times an item occurred in the past year (Frequency). Classifying each case into three categories: none, minor only, or severe (severity level). Classifying each case as respondent only, partner only, or both (mutuality types).

次要结局

  • Improved Gender Attitude(Base-line, and End-line (5 months post-intervention))
  • Improved Household Food Security(Base-line, and End-line (5 months post-intervention))
  • Increased Resilience(Base-line, and End-line (5 months post-intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Zulfiqar Ahmed Bhutta

Professor

Aga Khan University

研究点 (2)

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