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临床试验/NCT03195036
NCT03195036已完成不适用

Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon

Duke University1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2017年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
230
试验地点
1
主要终点
Attainment of age-appropriate developmental milestones

研究概览

简要总结

There is substantial evidence that early childhood development (ECD) programming can improve child health and development outcomes. An important component of ECD programming is supporting positive parenting and early stimulation practices. While many parents could benefit from such programming, mothers that are HIV-infected may particularly benefit given the higher risks of poorer child development among HIV-exposed children. Catholic Relief Services (CRS) in Cameroon is implementing the Key Interventions to Develop Systems and Services (KIDSS) ECD program for HIV-exposed children. This impact evaluation will ascertain to what extent the KIDSS home-based component of the ECD model affects attainment of age-appropriate developmental milestones (measured by the Ages and Stages Questionnaire 3 (ASQ-3)) in HIV-exposed children in Cameroon. The study design is a cluster-randomized controlled trial with a cohort of 200 mother/child dyads across 10 study clinics. HIV+ mothers will be recruited during pregnancy and their children will be followed up until 18 months of age. The intervention group will receive regular home-based ECD services focused on positive parenting and early stimulation. The control group will not have any exposure to ECD services, though they may receive home-based services focused on HIV care and treatment, hygiene, and nutrition. Randomization occurs at the clinic (cluster) level.

研究设计

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

入排标准

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

入选标准

  • HIV-positive
  • Pregnant and currently in 3rd trimester
  • Must reside in Nkoldongo district or Djoungolo district
  • Willing to be followed up for up to 21 months (pregnancy + postpartum periods)
  • Agrees to voluntary participation

排除标准

  • 未提供

结局指标

主要结局

Attainment of age-appropriate developmental milestones

时间窗: ASQ-3 score assessed 6 months after birth.

Child Development Outcomes, measured by ASQ-3 (6-month survey)

次要结局

  • Attainment of age-appropriate developmental milestones(ASQ-SE score assessed at 18 months after birth.)

研究者

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

Joy Noel Baumgartner

Assistant Research Professor; Director, Evidence Lab

Duke University

研究点 (1)

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