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临床试验/NCT02165371
NCT02165371已完成不适用

Sinovuyo Caring Families Project

University of Cape Town2 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
296
试验地点
2
主要终点
Eyberg Child Behavior Inventory

研究概览

简要总结

It has been established that children in families affected by either intimate partner violence or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) are at substantially increased risk of poor parenting and child maltreatment. In the sub-Saharan African context of high levels of HIV/AIDS and family violence, it is crucial that parents be supported to establish positive parenting practices and reduce harsh or abusive parenting within their families.This randomized controlled trial will be testing the Sinovuyo Caring Families Program (n = 296), a 12-session (2.5 hour per session) parenting intervention for primary caregivers of children between 2 and 9 years old. Participants will not be restricted to biological parents and include primary caregivers of children between 2 and 9 years old, who live in the same house as the child at least 4 nights per week. Participants will be recruited through systematic household sampling, liaising with Western Cape Department of Social Development and local community-based NGOs. Self-reporting questionnaires and qualitative observational assessment data for intervention and control groups will be collected at pre- and post-test evaluation as well as 12-month follow-up. Primary outcomes will include child behaviour problems, harsh and inconsistent parenting and positive parenting. Secondary outcomes will include parental depression, parental stress, parental monitoring and supervision and parent perceived social support.

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
Single (Outcomes Assessor)

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

  • Caregiver must live with child at least 4 nights per week
  • Child must be between 2 and 9 years old Live in Khayelitsha or Nyanga
  • May include biological parents, relatives or non-kin foster caregivers, with no restrictions on biological relationship
  • Participant must self-identify as the primary caretaker of the child
  • Children scoring 15 or higher in the Eyberg Child Behaviour Inventory problem scale

排除标准

  • Children scoring 14 or lower in the Eyber Child Behaviour Inventory problem scale
  • Participants with child not between 2 and 9 years old
  • Participants not self-identifying as the primary care take of the child
  • Participants not living with the child at least 4 nights per week.

结局指标

主要结局

Eyberg Child Behavior Inventory

时间窗: Baseline, post- intervention and 12-month post-intervention follow-up

This 36-item examines externalising behaviour problems in children ages 2 to 16 using both an Intensity Scale and Problem Scale. Parents are asked how often a specific behavior occurs and whether the behavior is considered a problem. Based on the most typical child behavior problems, items include "has poor table manners," "acts defiant when told to do something," "physically fights with sisters and brothers," and "fails to finish tasks or project." The Intensity Scale rates frequency of occurrence based on a 7-point Likert scale (1 = never occurs to 7 = always occurs). The Problem Scale measures whether the parent identifies a specific behavior as a problem (0 = no; 1 = yes). Both scales are summed up to create a total Intensity Score and Problem Score. Clinical cut-off scores suggested for psychopathological problem behavior are 131 for the Intensity Score and 11 for the Problem Score (Eyberg, 1999).

Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale)

时间窗: Baseline, post- intervention and 12-month post-intervention follow-up

Parental self-report of positive parenting will be assessed with the Parenting Young Children Scale (PARYC) subscales for supportive positive behaviour and setting limits. The PARYC (21 items total) measures the occurrence of specific parental behaviour towards children during the previous month on a 7-point Likert scale (0 = never; 6 = always), as well as whether performing this behaviour is currently a problem or difficult (0 = no; 1 = yes).

Sinovuyo Observational Coding System

时间窗: Baseline, post- intervention and 12-month post-intervention follow-up

This study will also conduct observational assessments of child behaviour using the Sinovuyo Observational Coding System (SOCS). This coding system is based on the Dyadic Parent- Child Interaction Coding System, but has been adapted to be simpler and quicker to use. This tool was developed during the pilot RCT of the Sinovuyo Caring Families Programme to provide a valid and reliable means of coding the behavioural categories that the programme aims to address.

次要结局

  • Beck Depression Inventory-II(Baseline, post- intervention and 12-month post-intervention follow-up)
  • Alabama Parenting Questionnaire (Poor monitoring/supervision subscale)(Baseline, post- intervention and 12-month post-intervention follow-up)
  • Medical Outcome Study Social Support Survey (Emotional Support subscale)(Baseline, post- intervention and 12-month post-intervention follow-up)
  • Parenting Stress Index Short Form(Baseline, post- intervention and 12-month post-intervention follow-up)

研究者

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

Dr Catherine L. Ward

Principal Investigator

University of Cape Town

研究点 (2)

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