Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 20
- 主要终点
- Maternal sensitivity
研究概览
简要总结
The aim of this study is to assess if an early therapeutic management focused on the mother-baby interaction using Interaction Guidance Therapy (IGT) with video feedback, brings an improvement of the maternal sensitivity in the interaction but also a decrease of the post-traumatic maternal symptoms.
Post Natal Post traumatic stress is known as a disorder that impaired maternal mental health but also development of motherhood and the construction of the bond to the baby through interactive disturbances.
The investigators will screen, among women who had a traumatic perception of an event related to the pregnancy or the childbirth, those who still present posttraumatic stress symptoms at 4 weeks post-partum. Four weeks from the traumatic event is the minimum delay to qualify a PTSD.
After randomization IGT versus Treatment As Usual (TAU), the investigators planned an early therapeutic intervention, 3 sessions at 8, 10 and 12 weeks of post-partum.
The investigators will assess the effect of the IGT on Maternal sensitivity and on the intensity of post-traumatic stress symptoms at 3 month post-partum and 1year.
详细描述
The investigators will compare the efficacy of Interactive Guidance Therapy, a parent-infant psychotherapy using video feed back versus a dyadic treatment conduct as usual (TAU) in women who present a post traumatic stress disorder related to childbirth or pregnancy.
The main assessment is the maternal sensitivity, assessed during a video recorded free play interaction between the mother and the baby and rate with the Coding of interactive Behaviour (CIB).
This is a Single Blind Randomized clinical trial. Only the rating of the (CIB), which is the primary end point, will be done blind for the treatment the dyad received.
The randomization will proceed after the inclusion visit and the first assessment that take place at 6 weeks of post partum.
The following assessments will take place at 4 months and 12 months. The investigators will conduct a national multicentre study with 5 inclusions centres, which are all child psychiatry unit specialized in perinatal period and already train or in training for the IGT method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the mother:
- •Mother over 18 years old, who gave birth to a healthy child
- •Mother having a PCL-5 score higher than > 31, 5 +/- 1 week after delivery and the traumatic event is related to childbirth or pregnancy.
- •Mother Speaking and reading French,
- •Mother with signed consent
- •Mother with rights open to social security
- •Mother and Father consent to the participation of the baby
- •For the father:
- •holder of parental authority
- •Speaking and reading French
- •Consent to self-reported questionnaires
排除标准
- •PTSD not related to pregnancy or birth.
- •Child's health situation who impact the feasibility of the protocol, with a risk of hospitalization of more than 3 days between 6 and 12 weeks of life
- •Childbirth under 34 weeks of gestational age
- •Any mother's acute, somatic or psychiatric clinical condition not compatible with the research procedure
研究组 & 干预措施
Interactive Guidance Therapy
Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.
干预措施: Interaction Guidance Therapy (Behavioral)
Interactive Guidance Therapy
Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.
干预措施: Interview (Behavioral)
Interactive Guidance Therapy
Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.
干预措施: Self-rated questionnaires (Behavioral)
Treatment as usual
Mother child psychotherapeutic sessions without video feed back.
干预措施: Mother's child psychotherapeutic session (Behavioral)
Treatment as usual
Mother child psychotherapeutic sessions without video feed back.
干预措施: Interview (Behavioral)
Treatment as usual
Mother child psychotherapeutic sessions without video feed back.
干预措施: Self-rated questionnaires (Behavioral)
结局指标
主要结局
Maternal sensitivity
时间窗: At 4 months
Evaluate by Coding Interactive Behaviour (CIB)
次要结局
- Infant symptoms SCL(At 12 months)
- both parents' bonding to the child(At 12 months)
- Prevalence of post natal depressive symptoms(At 12 months)
- fathers' Post-traumatic stress disorder(At 12 months)
- both parents' anxiety(At 12 months)
- Maternal sensitivity at 12 months(At 12 months)
- Infant development ASQ(At 12 months)
- Father's depressive symptoms(At 12 months)
- both parents' perception of social support(At 12 months)
- both parents' perception of their marital relationship(At 12 months)
- Prevalence of PN-PTSD(At 12 months)
- Prevalence of PN-PTSD(At 4 months)
- Prevalence of post natal depressive symptoms(At 4 months)
- fathers' Post-traumatic stress disorder(At 4 months)
- Father's depressive symptoms(At 4 months)
- both parents' anxiety(At 4 months)
- both parents' perception of social support(At 4 months)
- both parents' perception of their marital relationship(At 4 months)
- both parents' bonding to the child(At 4 months)