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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB Number | Other Identifier | 2020-A02576-33 |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive Guidance Therapy | Experimental | Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child. |
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| Treatment as usual | Active Comparator | Mother child psychotherapeutic sessions without video feed back. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interaction Guidance Therapy | Behavioral | Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal sensitivity | Evaluate by Coding Interactive Behaviour (CIB) | At 4 months |
| 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) |
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Inclusion Criteria:
For the mother:
For the father:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bérengère BEAUQUIER-MACCOTTA, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besançon | Besançon | 25 000 | France | |||
| CHU - Maternité |
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| Mother's child psychotherapeutic session | Behavioral | Mother's representation of the event, mother's representation of the relation to her child, maternal emotions. |
|
| Interview | Behavioral | History and perception of the mother's issues. |
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| Self-rated questionnaires | Behavioral | Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child |
|
| 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 |
| Besançon |
| 25000 |
| France |
| Centre hospitalier Intercommunal André Grégoire | Montreuil | 93100 | France |
| Etablissement Ville Evrard | Noisy-le-Sec | 93130 | France |
| Centre hospitalier Saint Anne | Paris | 75014 | France |
| Hôpital Saint Joseph - Maternité | Paris | 75014 | France |
| Hôpital Necker - Enfants malades - pedospychiatrie | Paris | 75015 | France |
| Hôpital Necker - Maternity | Paris | 75015 | France |
| CHRU Reims | Reims | 51000 | France |
| Centre hospitalier - unité de périnalité | Reims | 51100 | France |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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