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临床试验/NCT00298311
NCT00298311已完成不适用

An RCT to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression

Canadian Research Institute for Social Policy0 个研究点目标入组 60 人开始时间: 2005年11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
发起方
入组人数
60
主要终点
maternal-infant interaction

研究概览

简要总结

The objective of this study is to examine the impact of a home-based peer support intervention for mothers affected by postpartum depression (PPD) and for their infants.

详细描述

This controlled study will help establish the link between support for maternal caregiving, maternal-infant interaction, infant neuroendocrinology and infant cognitive and social development. The primary hypothesis predicts that home-based peer support will improve maternal-infant interactions. Secondary hypotheses predict that home-based peer support will: improve infants' cognitive development; improve infants' social development; decrease average daily salivary cortisol levels in infants; reduce maternal depressive symptomatology; and improve maternal perceptions of social support.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Eligible mothers will be identified as experiencing symptoms of PPD and scores >12 on the Edinburgh Postnatal Depression Scale.
  • Mothers must speak English or French.
  • Mothers will not be excluded for taking anti-depressant or anti-psychotic medication, using other interventions for PPD, or reporting a history of mental illness;
  • The infant must be full-term, in the care of the mother and between 3 to 6 months of age at initial enrollment.

排除标准

  • Infants who have been admitted to the NICU
  • Infants will be excluded if medicated with corticosteroids

研究组 & 干预措施

mci guidance & peer social support

Experimental

home visits to promote maternal-child interaction & social support

干预措施: mci guidance peer support (Behavioral)

peer social support

Sham Comparator

social support

干预措施: mci guidance peer support (Behavioral)

结局指标

主要结局

maternal-infant interaction

时间窗: 12 months

次要结局

  • cognitive development(12 months)
  • social development(12 months)
  • salivary cortisol(12 months)
  • depressive symptomatology(12 months)
  • social support(12 months)

研究者

发起方
Canadian Research Institute for Social Policy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Nicole LeTourneau

Professor

University of Calgary

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