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临床试验/NCT02394444
NCT02394444已完成不适用

Impact of a Psychological Post-hospital Intervention Aimed at Facilitating Parents-child Attachment and Preventing the Preterm Infants' Psycho-emotional, Social and Cognitive Disturbances

University Hospital, Caen0 个研究点目标入组 89 人开始时间: 2006年6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
89
主要终点
"Parent-Infant Relationship" assessed by Q-sort attachment scores : assessing the score of the attachment security of the infant at the corrected age of 18 months

研究概览

简要总结

The aim of this study was to assess the impact of an early psychological intervention, Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental health, and preterm infant development in the motor, cognitive, emotional and behavioral domains at a corrected age of 18 months.

详细描述

Due to prematurity induced infant-mother separation at birth, sometimes for several weeks, and owing to the concerns it generates, preterm birth exposes the parent-child attachment link to disturbances, especially the mother-child attachment after discharge. Several psychological factors affect infant (distress, dysmaturity ) and parents (psychological pain). These can cause lasting parent-child interactions disruption and jeopardize the attachment process. These early link distortions may hinder the infant's behavioral-emotional and cognitive development. Prematurity psychological consequences may negatively influence biomedical risks. Understanding these premature infants' future development modalities and support involves taking into account intricate organic and psychological factors - which may be combined as well.

Post-hospital psychological intervention with the family, focusing on parental mental health and triadic parent-infant relationship, proves an essential element in these children care, whose birth conditions were painful.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
28 Weeks 至 35 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Enrolled preterm infant were required to be between 28 and 35 weeks gestational age +6 days
  • Enrolled the parents were required to be French speakers, over 18 years old and residing within 50-kilometres radius of hospital

排除标准

  • preterm infant without congenital anomalies or any other foreseeable disabilities during the neonatal period
  • parents without known psychiatric history

结局指标

主要结局

"Parent-Infant Relationship" assessed by Q-sort attachment scores : assessing the score of the attachment security of the infant at the corrected age of 18 months

时间窗: assessment at the corrected age of 18 months

We needed to use a variety of measures because these measures had to be tailored to the child's stage of development. To ensure the relative strength conclusion on the treatment effect, the statistic analyses of test scores each time point were made using bonefferoni correction for multiple comparisons. Parenting Stress Index ( PSI-SF), "R" interview and Q-sort attachment were tests based on the infant's age at different assessment periods.

Change in the "Parent-Infant Relationship" assessed by Parenting Stress Index ( PSI-SF) scores : assessing level of stress in parenting

时间窗: assessments at each time point: at the corrected ages of 3 and 18 months

Change in "Parent-Infant Relationship" assessed by "R" interview scores : assessing level of parental self-esteem

时间窗: assessments at each time point: at the corrected ages of 3 and 18 months

次要结局

  • Change in "Parental Mental Health" assessed by Post-Traumatic Stress Disorder (PTSD) scores: assessing level of post-traumatic stress(assessments at each time point: at 44 weeks gestational age and at the corrected age of 18 months)
  • Change in "Parental Mental Health" assessed by Beck Depression Inventory (BDI) scores: assessing level of depression(assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months)
  • Change in "Parental Mental Health" assessed by Edinburgh Postnatal Depression Scale (EPDS) scores: assessing level of postpartum depression(assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months)
  • "Infant Development" assessed by the Neonatal Behavioral Assessment Scale (NBAS) scores: assessing the baby's neurobehavioral development(assessments at 44 weeks gestational age)
  • Change in "Infant Development"assessed by the Brunet-Lezine Psychomotor Development Scales: assessing developmental quotient (DQ)(assessments at each time point: at the corrected ages of 3, 9 and 18 months)
  • Change in "Infant Development"assessed by Infant Behavioral Symptom scores:assessing scores behaviors and emotional capabilities(assessments at each time point: at the corrected ages of 9 and 18 months)

研究者

申办方类型
Other
责任方
Sponsor

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