跳至主要内容
临床试验/NCT00392847
NCT00392847已完成不适用

Promoting Parental Skills and Enhancing Attachment in Early Childhood

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2006年12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
440
试验地点
2
主要终点
Mothers' scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old)

研究概览

简要总结

Child psychological/behavioural disorders such as withdrawal may persist when the psychosocial context is unfavourable. Health promotion strategies (Olds' paradigm) have proved their efficacy in vulnerable populations. CAPEDP project sets out to evaluate a program of home visits in France

详细描述

This program aims at reducing psychosocial disorders and promoting mental health, social support and attachment amongst at-risk young women and their family. 440 primigravida (pregnant women) will be randomised into two groups. The first group will receive routine follow-up as currently provided by national community health and social services. The second group will receive home visits by community workers. These visits will start during pregnancy and will continue up to the child's second birthday.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
— 至 26 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Being less than 26 years old
  • Being pregnant for less than 27 weeks
  • Being primiparous
  • Living in the study area
  • Being socially vulnerable: less than 12 years of education AND/OR socially isolated AND/OR eligible for a public health insurance for people with low resources.

排除标准

  • Refusal to participate
  • Not able to speak French
  • Having a medical follow-up which necessitates regular contact with health professional
  • Not having health insurance
  • Persons for whom follow up at 27 months is impossible (evaluation at baseline)

结局指标

主要结局

Mothers' scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old)

时间窗: baseline, and when the child is 3, 6 and 12 months old

Parental competencies (when the child is 3, 12 and 18 months old)

时间窗: when the child is 3, 12 and 18 months old

Child mental health (when the child is 18 and 24 months old)

时间窗: when the child is 18 and 24 months old

次要结局

  • Child psychomotor development (when the child is 6, 12 and 24 months old)(when the child is 6, 12 and 24 months old)
  • Mother's knowledge about child development (baseline, and when the child is 3 and 24 months old)(baseline, and when the child is 3 and 24 months old)
  • Child attachment (when the child is 18 months old)(when the child is 18 months old)
  • Family use of medical and social services (baseline, and when the child is 3, 6, 12 and 24 months old)(baseline, and when the child is 3, 6, 12 and 24 months old)
  • Family social support (baseline, and when the child is 3, 12 and 24 months old)(baseline, and when the child is 3, 12 and 24 months old)
  • Mother's self-esteem as a parent (when the child is 3, 12 and 24 months old)(when the child is 3, 12 and 24 months old)
  • Mother's attachment (at baseline)(at baseline)
  • Mother's mental health (baseline, and when the child is 3 and 24 months old)(baseline, and when the child is 3 and 24 months old)
  • Mother's working alliance with home visitor (not for control group) (when the child is 3, 6, 12 and 24 months old)(not for control group,when the child is 3, 6, 12 and 24 months old)
  • Social-demographic data (all follow-up points: baseline, and when the child is 3, 6, 12, 18 and 24 months old)(baseline, and when the child is 3, 6, 12, 18 and 24 months old)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验