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临床试验/NCT03594617
NCT03594617已完成不适用

Improving Care and Preventing Maltreatment of Orphans: A Cluster-randomized Controlled Study With Caregivers

University of Konstanz1 个研究点 分布在 1 个国家目标入组 374 人开始时间: 2018年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
374
试验地点
1
主要终点
Change in children's exposure to harsh discipline by caregivers

研究概览

简要总结

Sub-Saharan Africa, with more than 56 million orphans worldwide, is the most affected region in terms of orphans to be cared for (UNICEF, 2014). The recently developed preventative approach Interaction Competencies with Children - for Caregivers (ICC-C; Hecker, Mkinga, Ssenyonga, & Hermenau, 2017) trains the essential interaction skills in working with children. The focus here is on strengthening a warm, sensitive and reliable relationship between caregiver and child as well as on non-violent education strategies. In a first pilot study the feasibility of the approach icould be demonstrated (Hermenau, Kaltenbach, Mkinga, & Hecker, 2015).

The study applies a two-arm cluster-randomized controlled design. The participating institutions will be randomly divided into intervention and control bodies. The follow-up examination should take place three months after the intervention. All caregivers in facility (N = approx. 150) and 25 randomly selected children (age: 6-12) per facility (N = 200) will be included in this study.

详细描述

Sub-Saharan Africa, with more than 56 million orphans worldwide, is the most affected region in terms of orphans to be cared for (UNICEF, 2014). The few studies investigating children in African orphanages mostly showed inadequate care (Espié et al., 2011; Hermenau et al., 2011; Levin & Haines, 2007; Wolff & Fesseha, 1998, 1999). In addition to the lack of trained and competent caregivers, children are also confronted with violence and abuse in the orphanages themselves (Hermenau et al., 2011; SOS Children's Villages International & University of Bedfordshire, 2014). Abuse and neglect in orphanages, in addition to traumatisation, abuse and neglect in the families of origin, pose a considerable risk for the healthy development and mental health of children (Hermenau, Goessmann, Rygaard, Landolt, & Hecker, 2017). In addition to meeting basic needs (e. g. eating, drinking, basic medical care, etc.), sensitive and non-violent education in orphanages is crucial for the emotional and physical development of children. However, the focus of previous intervention studies has been on promoting a sensitive and reliable relationship between caregiver and child. Violence and maltreatment, on the other hand, received little attention (Hermenau et al., 2017).

The recently developed preventative approach Interaction Competencies with Children - for Caregivers (ICC-C; Hecker, Mkinga, Ssenyonga, & Hermenau, 2017) trains the essential interaction skills in working with children. The focus here is on strengthening a warm, sensitive and reliable relationship between caregiver and child as well as on non-violent education strategies. In a first pilot study the feasibility of the approach could be demonstrated (Hermenau, Kaltenbach, Mkinga, & Hecker, 2015).

The study applies a two-arm cluster-randomized controlled design and includes 20 to 25 orphanages. After an initial investigation, the participating institutions will be randomly divided into intervention and control bodies. The follow-up examination should take place three months after the intervention. In addition, feasibility data will be assessed in the intervention facilities only at the beginning and the end of the intervention. All caregivers in facility (N = approx. 150) and 10-15 randomly selected children (age: 6-12) per facility (N = 300) will be included in this study. Data of caregivers will be assessed with the help of self-administered questionnaires, whereas data of children will be assessed with structured interviews.

There is a clear and pressing humanitarian need for science to address the issue of care quality and maltreatment prevention in institutional care settings in a practical manner. Perhaps surprisingly in view of this, so far no evidenced-based prevention measures adapted for the limited resources in low-income countries have been developed and scientifically evaluated. This research project can address this need, with a scientifically rigorous evaluation of a violence and maltreatment prevention program that fosters the active involvement of local personnel and that considers the limited resources of school settings in low-income countries. Through these efforts this study may help more orphans to grow-up in a supportive atmosphere, maintaining their psychological well-being and improving their performance. This preventative program aims to make a significant impact on the psychological well-being of orphans in Tanzania.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for caregivers:
  • Legal age
  • Written informed consent
  • Inclusion Criteria for children:
  • Between 6 and 12 years
  • Written informed consent by head of institutional care facility & children oral assent

排除标准

  • for caregivers:
  • Acute drug or alcohol intoxication
  • Known psychiatric disorder
  • Exclusion Criteria for children:
  • Known psychiatric disorder

结局指标

主要结局

Change in children's exposure to harsh discipline by caregivers

时间窗: CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)

The Conflict Tactics Scale Parent-Child version (CTSPC) will assess the children's self-reported experiences of violent discipline in the child care institution. The focus will be particularly on the subscales physical violence (13 items, potential range: 0 to 325 with higher scores indicating more violence) and emotional violence (5 items, potential range: 0-125, with higher scores indicating more violence).

Change in caregivers' application of harsh discipline

时间窗: The CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)

The Conflict Tactics Scale Parent-Child version (CTSPC) will assess caregiver's use of violent discipline measure against children in the child care institution. All items are rated on a 7-point Likert scale from never (0) to more than 20 times (25). The focus will be particularly on the subscales physical violence (13 items, potential range: 0 to 325 with higher scores indicating more violence) and emotional violence (5 items, potential range: 0-125, with higher scores indicating more violence).

次要结局

  • Change in student's mental health(SDQ will be used at (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention))
  • Change in caregiver's attitudes towards harsh discipline(The adapted version of CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention))

研究者

发起方
University of Konstanz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Thomas Elbert

Full Professor of Clinical Psychology and Behvavioral Neuroscience

University of Konstanz

研究点 (1)

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