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临床试验/NCT06476626
NCT06476626尚未招募不适用

Maternal Reflective Functioning During the Transition to Motherhood as a Protective Factor in the Relationship Between Personal and Environmental Characteristics and the Mental Health of Both the Mother and the Infant

University of Haifa2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
2
主要终点
Maternal Reflective Functioning questionnaires

研究概览

简要总结

The goal of this clinical trial is to learn about Maternal Reflective Function (MRF) during the transition to motherhood. The main questions it aims to answer are:

Does MRF mediates the connection between risk factors for mental health difficulties during first pregnancy and motherhood (the transition to motherhood) and outcomes related to the mother, the infant, and their relationship.

Participants will:

Answer questionnaires and clinical interviews during pregnancy and after birth of the first child (twice at third trimester, 1 and 3 months after birth).

intervention group will participate in an online short intervention to enhance MRF.

详细描述

Using this trial, the investigators will be able to better understand rather MRF moderate the connection between risk factors to outcomes after birth related to both the mother and the infant. Using RCT design we will be able to understand mechanism of change.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

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

  • pregnant women in 27-30 weeks pregnant in enrollment
  • speak read and understand Hebrew
  • Has a connection to internet and ZOOM platform.
  • Ready to participate in a group workshop

排除标准

  • Women who can't participate in a online workshop due to physical or mental health difficulties.

结局指标

主要结局

Maternal Reflective Functioning questionnaires

时间窗: Twice in third trimester of pregnancy (Before and after intervention), 1 and 3 months after birth.

Will be measured using Parental Reflective Function questionnaires for pregnancy P-PRFQ (Pajulo et al., 2015) and after birth (Parental Reflective Functioning Questionnaire PRFQ, Luyten et al., 2017). Likert Scale from 1 (Greatly disagree) to 7 (Greatly agree).

Maternal Reflective Functioning interviews

时间窗: Once in third trimester of pregnancy ,1 months after birth.

Will be measured using Pregnancy Interview (PI, Slade et al., 1987; Slade, 2003) before labor, and Parental Developmental Interview (PDI-R2 short form, Slade et al., 2003) after labor. Reflective Function Coding Scale- from -1 (No Reflective Function) to 9 (Very high Reflective Function)

次要结局

  • Anxiety(Third trimester of pregnancy, 1 and 3 months after birth.)
  • Social Support(Third trimester of pregnancy, 1 and 3 months after birth.)
  • Infant weight(1 and 3 months after birth.)
  • Depression.(Third trimester of pregnancy, 1 and 3 months after birth.)
  • High risk pregnancy(At enrollment.)
  • Cognitive bias(Third trimester of pregnancy, 3 months after birth.)
  • Mother Emotional Regulation(Third trimester of pregnancy, 1 and 3 months after birth.)
  • Exposure to traumatic life events(At enrollment.)
  • Relationship satisfaction(Third trimester of pregnancy, 1 and 3 months after birth.)
  • Mother-infant bonding(Third trimester of pregnancy, 1 and 3 months after birth.)
  • Quality of sleep(1 and 3 months after birth.)
  • Maternal self-efficacy(1 and 3 months after birth.)

研究者

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

Yael Enav

Head of Emotional Regulation and Mentalization Lab

University of Haifa

研究点 (2)

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