Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 90
- Locations
- 10
- Primary Endpoint
- Maternal sensitivity
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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. * Pre-screening in post partum ward or during post partum consultation. * Pre Inclusion at 5 (+-1) weeks to assess PTSD with Post traumatic checklist (PCL -5) * Inclusion and First assessment at 6 weeks post partum * Randomization: 3 session of IGT or TAU at 8 weeks, 10 weeks and 12 weeks Assessment at 4 months (+/-2W) and 12 months (+/- 1M)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maternal sensitivity
Time Frame: At 4 months
Evaluate by Coding Interactive Behaviour (CIB)
Secondary Outcomes
- 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)