Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress
NCT ID: NCT04916938
Last Updated: 2022-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2021-12-29
2024-12-31
Brief Summary
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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.
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Interaction Guidance Therapy
Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.
Interview
History and perception of the mother's issues.
Self-rated questionnaires
Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child
Treatment as usual
Mother child psychotherapeutic sessions without video feed back.
Mother's child psychotherapeutic session
Mother's representation of the event, mother's representation of the relation to her child, maternal emotions.
Interview
History and perception of the mother's issues.
Self-rated questionnaires
Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child
Interventions
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Interaction Guidance Therapy
Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.
Mother's child psychotherapeutic session
Mother's representation of the event, mother's representation of the relation to her child, maternal emotions.
Interview
History and perception of the mother's issues.
Self-rated questionnaires
Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Bérengère BEAUQUIER-MACCOTTA, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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CHU Besançon
Besançon, , France
CHU - Maternité
Besançon, , France
Centre hospitalier Intercommunal André Grégoire
Montreuil, , France
Etablissement Ville Evrard
Noisy-le-Sec, , France
Centre hospitalier Saint Anne
Paris, , France
Hôpital Saint Joseph - Maternité
Paris, , France
Hôpital Necker - Enfants malades - pedospychiatrie
Paris, , France
Hôpital Necker - Maternity
Paris, , France
CHRU Reims
Reims, , France
Centre hospitalier - unité de périnalité
Reims, , France
Countries
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Central Contacts
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Facility Contacts
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Rajeev RAMANAH, MD, PhD
Role: primary
Bruno RENEVIER, MD
Role: primary
Romain DUGRAVIER, MD
Role: primary
Elie AZRIA, MD, PhD
Role: primary
Yves VILLE, MD, PhD
Role: primary
Anne-catherine ROLLAND, MD, PhD
Role: primary
Other Identifiers
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ID-RCB Number
Identifier Type: OTHER
Identifier Source: secondary_id
APHP180615
Identifier Type: -
Identifier Source: org_study_id
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