Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress

Study Overview
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Brief Summary
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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
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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)

Official Title
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Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress

Conditions
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Post-traumatic Stress Disorder (PTSD)

Intervention / Treatment
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* Behavioral: Interaction Guidance Therapy
* Behavioral: Mother's child psychotherapeutic session
* Behavioral: Interview
* Behavioral: Self-rated questionnaires


Participation Criteria
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Eligibility Criteria
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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 Consent to self-reported questionnaires Exclusion Criteria 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 Twins Stillbirth Any mother's acute, somatic or psychiatric clinical condition not compatible with the research procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive Guidance Therapy<br>Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child. | Behavioral: Interaction Guidance Therapy<br>* Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.<br>Behavioral: Interview<br>* History and perception of the mother's issues.<br>Behavioral: Self-rated questionnaires<br>* Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child<br>|
| Active Comparator: Treatment as usual<br>Mother child psychotherapeutic sessions without video feed back. | Behavioral: Mother's child psychotherapeutic session<br>* Mother's representation of the event, mother's representation of the relation to her child, maternal emotions.<br>Behavioral: Interview<br>* History and perception of the mother's issues.<br>Behavioral: Self-rated questionnaires<br>* Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal sensitivity | Evaluate by Coding Interactive Behaviour (CIB) | At 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal sensitivity at 12 months | Evaluate by Coding Interactive Behaviour (CIB) | At 12 months | 
| Prevalence of PN-PTSD | Evaluate by Post-traumatic stress disorder Checklist version DSM-5 (PCL-5) | At 4 months | 
| Prevalence of PN-PTSD | Evaluate by Post-traumatic stress disorder Checklist version DSM-5 (PCL-5) | At 12 months | 
| Prevalence of post natal depressive symptoms | Evaluation by Edinburgh post natal depression scale (EPDS) | At 4 months | 
| Prevalence of post natal depressive symptoms | Evaluation by Edinburgh post natal depression scale (EPDS) | At 12 months | 
| Infant development ASQ | assessed with questionnaire fulfilled by both parents Age and Stage Questionnaire-12 (ASQ-12) Minimal score is 0 (worse) - Maximal score is >= 30 | At 12 months | 
| Infant symptoms SCL | assessed with questionnaire fulfilled by both parents : Symptoms Checklist (SCL) Minimal score is 0 (worse) - Maximal score is >= 30 | At 12 months | 
| fathers' Post-traumatic stress disorder | assessed with Post-traumatic stress disorder Checklist (PCL-5) Minimal score is 0 Maximal score is 80 (worse) | At 4 months | 
| fathers' Post-traumatic stress disorder | assessed with Post-traumatic stress disorder Checklist (PCL-5) Minimal score is 0 Maximal score is 80 (worse) | At 12 months | 
| Father's depressive symptoms | assessed with Edinburgh post natal depression scale (EPDS) Minimal score is 0 - Maximal score is 30 (worse) | At 4 months | 
| Father's depressive symptoms | assessed with Edinburgh post natal depression scale (EPDS) Minimal score is 0 - Maximal score is 30 (worse) | At 12 months | 
| both parents' anxiety | assessed with State Trait Anxiety Inventory (STAI) Minimal score is 20 - Maximal score is 80 (worse) | At 4 months | 
| both parents' anxiety | assessed with State Trait Anxiety Inventory (STAI) Minimal score is 20 - Maximal score is 80 (worse) | At 12 months | 
| both parents' perception of social support | assessed with Social Support Scale (SSQ) Minimal score is 0 (worse) - Maximal score is 54 | At 4 months | 
| both parents' perception of social support | assessed with Social Support Scale (SSQ) Minimal score is 0 (worse) - Maximal score is 54 | At 12 months | 
| both parents' perception of their marital relationship | assessed with Dyadic Adjustment Scale (DAS) Minimal score is 16 (worse) - Maximal score is 96 | At 4 months | 
| both parents' perception of their marital relationship | assessed with Dyadic Adjustment Scale (DAS) Minimal score is 16 (worse) - Maximal score is 96 | At 12 months | 
| both parents' bonding to the child | assessed with Post-partum Bonding questionnaire (PBQ). Minimal score is 0 - Maximal score is 125 (worse) | At 4 months | 
| both parents' bonding to the child | assessed with Post-partum Bonding questionnaire (PBQ). Minimal score is 0 - Maximal score is 125 (worse) | At 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Natal Post-traumatic Stress Disorder (PN-PTSD), Interactive guidance therapy, Video feedback