Post-traumatic Stress Disorder (PTSD) Clinical Trial
— EVAGITOfficial title:
Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: For the mother: 1. Mother over 18 years old, who gave birth to a healthy child 2. Mother having a PCL-5 score higher than > 31, 5 +/- 1 week after delivery and the traumatic event is related to childbirth or pregnancy. 3. Mother Speaking and reading French, 4. Mother with signed consent 5. Mother with rights open to social security 6. Mother and Father consent to the participation of the baby For the father: 1. holder of parental authority 2. Speaking and reading French 3. Consent to self-reported questionnaires Exclusion Criteria 1. PTSD not related to pregnancy or birth. 2. 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 3. Childbirth under 34 weeks of gestational age 4. Twins 5. Stillbirth 6. Any mother's acute, somatic or psychiatric clinical condition not compatible with the research procedure |
Country | Name | City | State |
---|---|---|---|
France | CHU - Maternité | Besançon | |
France | CHU Besançon | Besançon | |
France | Centre hospitalier Intercommunal André Grégoire | Montreuil | |
France | Etablissement Ville Evrard | Noisy-le-Sec | |
France | Centre hospitalier Saint Anne | Paris | |
France | Hôpital Necker - Enfants malades - pedospychiatrie | Paris | |
France | Hôpital Necker - Maternity | Paris | |
France | Hôpital Saint Joseph - Maternité | Paris | |
France | Centre hospitalier - unité de périnalité | Reims | |
France | CHRU Reims | Reims |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal sensitivity | Evaluate by Coding Interactive Behaviour (CIB) | At 4 months | |
Secondary | Maternal sensitivity at 12 months | Evaluate by Coding Interactive Behaviour (CIB) | At 12 months | |
Secondary | Prevalence of PN-PTSD | Evaluate by Post-traumatic stress disorder Checklist version DSM-5 (PCL-5) | At 4 months | |
Secondary | Prevalence of PN-PTSD | Evaluate by Post-traumatic stress disorder Checklist version DSM-5 (PCL-5) | At 12 months | |
Secondary | Prevalence of post natal depressive symptoms | Evaluation by Edinburgh post natal depression scale (EPDS) | At 4 months | |
Secondary | Prevalence of post natal depressive symptoms | Evaluation by Edinburgh post natal depression scale (EPDS) | At 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Father's depressive symptoms | assessed with Edinburgh post natal depression scale (EPDS) Minimal score is 0 - Maximal score is 30 (worse) | At 4 months | |
Secondary | Father's depressive symptoms | assessed with Edinburgh post natal depression scale (EPDS) Minimal score is 0 - Maximal score is 30 (worse) | At 12 months | |
Secondary | both parents' anxiety | assessed with State Trait Anxiety Inventory (STAI) Minimal score is 20 - Maximal score is 80 (worse) | At 4 months | |
Secondary | both parents' anxiety | assessed with State Trait Anxiety Inventory (STAI) Minimal score is 20 - Maximal score is 80 (worse) | At 12 months | |
Secondary | both parents' perception of social support | assessed with Social Support Scale (SSQ) Minimal score is 0 (worse) - Maximal score is 54 | At 4 months | |
Secondary | both parents' perception of social support | assessed with Social Support Scale (SSQ) Minimal score is 0 (worse) - Maximal score is 54 | At 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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