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临床试验/NCT03332134
NCT03332134已完成不适用

Primary Prevention of Intimate Partner Violence in India

Emory University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
IPV Intervention Safety

研究概览

简要总结

The goal of this study is to test and evaluate the feasibility, acceptance, safety, and efficacy of an an intimate partner violence (IPV) intervention in recently-married, low-income husband-wife dyads in Pune, India.

详细描述

The goal of this study is to test and evaluate the feasibility, acceptance, safety, and efficacy of an an intimate partner violence (IPV) intervention in recently-married, low-income husband-wife dyads in Pune, India conducted over a six week period.

Acceptability and feasibility will be assessed through semi-structured interviews with participants and staff post-intervention. Safety will be gauged through semi-structured interviews with women participants and efficacy will be gauged through change in proximal determinants of IPV in this population (i.e. time spent in the relationship, self-esteem, resilience, communication and conflict management skills, sexual communication, attitudes toward IPV acceptability, and conceptualization of IPV).

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recently married (i.e. <1 year) husband-wife dyads
  • First marriage
  • Planning to reside in Pune for the majority of the next 6 months
  • Marathi fluency
  • Lives with partner
  • Lives in a slum, slum redevelopment community, or chawl

排除标准

  • Pregnant in third trimester of pregnancy
  • Women who respond affirmatively to either a physical and/or sexual IPV item on the IFVCS short form

研究组 & 干预措施

Married Couple Dyad

Experimental

Husband-wife dyads will receive the intimate partner violence (IPV) intervention program over the course of six weeks.

干预措施: Intimate Partner Violence (IPV) Prevention Intervention (Behavioral)

Control Group

No Intervention

Husband-wife dyads in the control group will not receive an intervention.

结局指标

主要结局

IPV Intervention Safety

时间窗: Duration of Study (Up to 3 Months)

Safety of the intervention will be gauged by extracting themes of incident IPV events or changes in IPV frequency or severity reported by the wife at the three-month follow-up through semi-structured interviews between administrators and participants.

IPV Intervention Acceptability

时间窗: Duration of Study (Up to 3 Months)

Acceptability of the intervention to the dyad will be collected qualitatively and gauged by extracting themes regarding acceptability of modular content, timing of the intervention, safety precautions, number and duration of the intervention sessions, and appropriateness of intervention staff through semi-structured interviews between administrators and participants.

IPV Intervention Feasibility

时间窗: Duration of Study (Up to 3 Months)

Intervention feasibility will be qualitatively assessed by extracting themes from post-session semi-structured interviews of difficulties in intervention delivery, participant understanding of the intervention, and logistical problems with the intervention setting, timing, staff training, and debriefings as reported by the intervention administrator.

次要结局

  • Change in Sexual Communication Skills(Baseline, Post-Intervention (3 Months))
  • Change in Time Spent Together(Baseline, Post-Intervention (3 Months))
  • Change in Self-esteem(Baseline, Post-Intervention (3 Months))
  • Change in Communication Skills(Baseline, Post-Intervention (3 Months))
  • Change in Conceptualization of IPV(Baseline, Post-Intervention (3 Months))
  • Change in Attitudes toward IPV Acceptability(Baseline, Post-Intervention (3 Months))
  • Change in Conflict Negotiation Skills(Baseline, Post-Intervention (3 Months))
  • Change in Reproductive Health Beliefs linked to IPV(Baseline, Post-Intervention (3 Months))

研究者

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

Ameeta Kalokhe

Assistant Professor

Emory University

研究点 (2)

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