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临床试验/NCT02506543
NCT02506543已完成不适用

Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia

Columbia University2 个研究点 分布在 2 个国家目标入组 1,014 人开始时间: 2015年8月最近更新:
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
1,014
试验地点
2
主要终点
Sexual violence in the past 12 months

研究概览

简要总结

The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls in three refugee camps in Ethiopia. The study design will employ a two group wait-list cluster randomized controlled trial where girls will be invited to participate in the COMPASS program, assigned to groups of approximately 20 for the purposes of the program, complete a pre-test baseline assessment, and will then be randomized by group to the intervention or control condition. In addition, qualitative research will address additional questions of acceptability, processes of change and best practice.

Groups in three refugee camps - Sherkole, Bambasi, and Tongo - will be randomized to determine whether the participants receive the intervention or are placed on the wait-list immediately following the baseline. Those that do not get the curriculum during the study will receive it following the endline phase of the study so as to not create tensions or jealousies.

The intervention, the COMPASS program, will involve a structured intervention for girls between the ages of 13-19 that is intended to engage adolescent girls, those who are influential in their lives, service providers and other stakeholders, with the ultimate goal of co-creating environments in which girls are valued and safe. The program is centered on establishing or supporting community-supported safe spaces for girls where they can come and gather among themselves and participate in a structured life-skills curriculum.

详细描述

The study assessment will employ a mixed methods approach with most data collection occurring at pre-test/baseline and post-intervention. Quantitative survey methods will be used to evaluate attitudes towards a host of topics related to physical and financial assets and health-related behaviors. Survey questions will be administered using Audio Computer Assisted Self-Interviewing (ACASI). Quantitative methods will be used to yield statistical measures of the scale of changes in attitudes, skills, and behaviors due to the intervention.

Qualitative methods at baseline will include focus group discussions with caregivers and participatory methods with girls to assess topics such as self-esteem, empowerment, safety, and resilience. Endline qualitative methods include in-depth interviews with caregivers, and small-group warm-up activities with adolescent girls, followed by in-depth interviews.

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
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • aged 13-19
  • speak one of the languages included in the study (Sudanese Arabic, Funj/Berta, Maban, Regarig and Engesena Quickly dialects)
  • give informed consent

排除标准

  • cognitive impairment

研究组 & 干预措施

COMPASS intervention

Experimental

Subjects in this group will be pre-tested at the same time with the subjects in the Wait-list control group. Subjects in this group will receive the intervention immediately after the initial pre-test/baseline assessment, which includes life skills education, access to mentors in safe spaces, and a structured parenting intervention for girls' caregivers. Then, the subjects in this group have completed the intervention (at 12-months post-intervention initiation), the subjects in this group will take the post-test at the same time with the subjects in the Wait-list control group.

干预措施: COMPASS (Behavioral)

Wait-list control

Active Comparator

No intervention

干预措施: No intervention (Behavioral)

结局指标

主要结局

Sexual violence in the past 12 months

时间窗: 12 months

A binary composite representing any form of sexual violence in the previous 12 months, which included self-reported forced sex, unwanted sexual touching, or coerced sex

次要结局

  • Change in baseline prevalence of physical abuse(12 months)
  • Change in baseline prevalence of early marriage(12 months)
  • Change in baseline prevalence of interpersonal relationships(12 months)

研究者

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

Lindsay Stark

Associate Professor of Population and Family Health at the Colum, Dept Population&Family Health

Columbia University

研究点 (2)

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