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临床试验/NCT05515094
NCT05515094Unknown不适用

Strengthening Women's Agency in Pregnancy (SWAP): Empowerment Counselling Intervention [ECI] for Pregnant Women and Girls Affected by Intimate Partner Violence in a Refugee Camp in Tanzania

International Rescue Committee0 个研究点目标入组 150 人开始时间: 2023年1月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
General Self-Efficacy Scale

研究概览

简要总结

This research aims to address the feasibility and acceptability of a brief empowerment counselling intervention (ECI) among pregnant women and girls receiving antenatal care (ANC) who have experienced intimate partner violence (IPV), in humanitarian healthcare settings.

详细描述

This research aims to address the feasibility and acceptability of a brief empowerment counseling intervention (ECI) among pregnant women and girls receiving antenatal care (ANC) who have experienced intimate partner violence (IPV), in humanitarian healthcare settings. This 3- year study will take place in two IRC-managed health posts in a refugee camp in Kigoma, Tanzania. The objectives of the study are to: 1) Adapt, as needed, for use in the context of ANC in a humanitarian setting, a brief ECI to address women's and girls' exposure to sexual and/or physical IPV during pregnancy, by improving their mental health, self-efficacy, safety, and coping strategies; 2) Test the ECI through a pilot randomized controlled trial, determining whether the intervention is feasible/acceptable and whether it improves women's self-efficacy, reduces mental distress and increases uptake of longer-term IPV services; 3) Test the feasibility of integrating such an intervention into pre-existing ANC service delivery in humanitarian settings and make recommendations for future intervention research and development, including effectively linking routine enquiry of IPV in ANC settings with support service use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women or girl aged 15 years or older:
  • Pregnant (any trimester);
  • Attending their 2nd or later ANC visit;
  • Have experienced physical and/or sexual and/or severe psychological IPV in the past 12 months;
  • Consent to participate.

排除标准

  • At their first ANC visit or accompanied by their partner (or anyone else) at the ANC visit;
  • Under age 15;
  • Unable to provide informed consent/assent;
  • Suicidal or at risk of severe violence or of being murdered; and/or
  • In a high-risk situation or medically high risk.

结局指标

主要结局

General Self-Efficacy Scale

时间窗: 3 months endline survey, present recall period

Adapted measure of the GSE Scale. Possible score 10-40; higher indicating more self-efficacy.

Patient Health Questionnaire - 9

时间窗: 3 months endline survey, past two week recall period

Depressive symptoms will be assessed via the PHQ-9 questionnaire. The range of scores is 0-27. A higher score indicates more symptoms.

次要结局

  • Intimate Partner violence-(Through study completion, average length three months;)
  • Checklist of Safety Behaviors(Through study completion, average length three months;)
  • Uptake of case management services(Through study completion, average length three months;)

研究者

申办方类型
Other
责任方
Sponsor

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