Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress (EVAGIT)
Primary Purpose
Post-traumatic Stress Disorder (PTSD)
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interaction Guidance Therapy
Mother's child psychotherapeutic session
Interview
Self-rated questionnaires
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Stress Disorder (PTSD) focused on measuring Post-Natal Post-traumatic Stress Disorder (PN-PTSD), Interactive guidance therapy, Video feedback
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
- 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
Sites / Locations
- CHU BesançonRecruiting
- CHU - Maternité
- Centre hospitalier Intercommunal André Grégoire
- Etablissement Ville Evrard
- Centre hospitalier Saint Anne
- Hôpital Saint Joseph - Maternité
- Hôpital Necker - Enfants malades - pedospychiatrieRecruiting
- Hôpital Necker - Maternity
- CHRU ReimsRecruiting
- Centre hospitalier - unité de périnalité
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interactive Guidance Therapy
Treatment as usual
Arm Description
Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.
Mother child psychotherapeutic sessions without video feed back.
Outcomes
Primary Outcome Measures
Maternal sensitivity
Evaluate by Coding Interactive Behaviour (CIB)
Secondary Outcome Measures
Maternal sensitivity at 12 months
Evaluate by Coding Interactive Behaviour (CIB)
Prevalence of PN-PTSD
Evaluate by Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)
Prevalence of PN-PTSD
Evaluate by Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)
Prevalence of post natal depressive symptoms
Evaluation by Edinburgh post natal depression scale (EPDS)
Prevalence of post natal depressive symptoms
Evaluation by Edinburgh post natal depression scale (EPDS)
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
Infant symptoms SCL
assessed with questionnaire fulfilled by both parents : Symptoms Checklist (SCL) Minimal score is 0 (worse) - Maximal score is >= 30
fathers' Post-traumatic stress disorder
assessed with Post-traumatic stress disorder Checklist (PCL-5) Minimal score is 0 Maximal score is 80 (worse)
fathers' Post-traumatic stress disorder
assessed with Post-traumatic stress disorder Checklist (PCL-5) Minimal score is 0 Maximal score is 80 (worse)
Father's depressive symptoms
assessed with Edinburgh post natal depression scale (EPDS) Minimal score is 0 - Maximal score is 30 (worse)
Father's depressive symptoms
assessed with Edinburgh post natal depression scale (EPDS) Minimal score is 0 - Maximal score is 30 (worse)
both parents' anxiety
assessed with State Trait Anxiety Inventory (STAI) Minimal score is 20 - Maximal score is 80 (worse)
both parents' anxiety
assessed with State Trait Anxiety Inventory (STAI) Minimal score is 20 - Maximal score is 80 (worse)
both parents' perception of social support
assessed with Social Support Scale (SSQ) Minimal score is 0 (worse) - Maximal score is 54
both parents' perception of social support
assessed with Social Support Scale (SSQ) Minimal score is 0 (worse) - Maximal score is 54
both parents' perception of their marital relationship
assessed with Dyadic Adjustment Scale (DAS) Minimal score is 16 (worse) - Maximal score is 96
both parents' perception of their marital relationship
assessed with Dyadic Adjustment Scale (DAS) Minimal score is 16 (worse) - Maximal score is 96
both parents' bonding to the child
assessed with Post-partum Bonding questionnaire (PBQ). Minimal score is 0 - Maximal score is 125 (worse)
both parents' bonding to the child
assessed with Post-partum Bonding questionnaire (PBQ). Minimal score is 0 - Maximal score is 125 (worse)
Full Information
NCT ID
NCT04916938
First Posted
March 19, 2021
Last Updated
October 31, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04916938
Brief Title
Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress
Acronym
EVAGIT
Official Title
Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder (PTSD)
Keywords
Post-Natal Post-traumatic Stress Disorder (PN-PTSD), Interactive guidance therapy, Video feedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interactive Guidance Therapy
Arm Type
Experimental
Arm Description
Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Mother child psychotherapeutic sessions without video feed back.
Intervention Type
Behavioral
Intervention Name(s)
Interaction Guidance Therapy
Intervention Description
Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.
Intervention Type
Behavioral
Intervention Name(s)
Mother's child psychotherapeutic session
Intervention Description
Mother's representation of the event, mother's representation of the relation to her child, maternal emotions.
Intervention Type
Behavioral
Intervention Name(s)
Interview
Intervention Description
History and perception of the mother's issues.
Intervention Type
Behavioral
Intervention Name(s)
Self-rated questionnaires
Intervention Description
Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child
Primary Outcome Measure Information:
Title
Maternal sensitivity
Description
Evaluate by Coding Interactive Behaviour (CIB)
Time Frame
At 4 months
Secondary Outcome Measure Information:
Title
Maternal sensitivity at 12 months
Description
Evaluate by Coding Interactive Behaviour (CIB)
Time Frame
At 12 months
Title
Prevalence of PN-PTSD
Description
Evaluate by Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)
Time Frame
At 4 months
Title
Prevalence of PN-PTSD
Description
Evaluate by Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)
Time Frame
At 12 months
Title
Prevalence of post natal depressive symptoms
Description
Evaluation by Edinburgh post natal depression scale (EPDS)
Time Frame
At 4 months
Title
Prevalence of post natal depressive symptoms
Description
Evaluation by Edinburgh post natal depression scale (EPDS)
Time Frame
At 12 months
Title
Infant development ASQ
Description
assessed with questionnaire fulfilled by both parents Age and Stage Questionnaire-12 (ASQ-12) Minimal score is 0 (worse) - Maximal score is >= 30
Time Frame
At 12 months
Title
Infant symptoms SCL
Description
assessed with questionnaire fulfilled by both parents : Symptoms Checklist (SCL) Minimal score is 0 (worse) - Maximal score is >= 30
Time Frame
At 12 months
Title
fathers' Post-traumatic stress disorder
Description
assessed with Post-traumatic stress disorder Checklist (PCL-5) Minimal score is 0 Maximal score is 80 (worse)
Time Frame
At 4 months
Title
fathers' Post-traumatic stress disorder
Description
assessed with Post-traumatic stress disorder Checklist (PCL-5) Minimal score is 0 Maximal score is 80 (worse)
Time Frame
At 12 months
Title
Father's depressive symptoms
Description
assessed with Edinburgh post natal depression scale (EPDS) Minimal score is 0 - Maximal score is 30 (worse)
Time Frame
At 4 months
Title
Father's depressive symptoms
Description
assessed with Edinburgh post natal depression scale (EPDS) Minimal score is 0 - Maximal score is 30 (worse)
Time Frame
At 12 months
Title
both parents' anxiety
Description
assessed with State Trait Anxiety Inventory (STAI) Minimal score is 20 - Maximal score is 80 (worse)
Time Frame
At 4 months
Title
both parents' anxiety
Description
assessed with State Trait Anxiety Inventory (STAI) Minimal score is 20 - Maximal score is 80 (worse)
Time Frame
At 12 months
Title
both parents' perception of social support
Description
assessed with Social Support Scale (SSQ) Minimal score is 0 (worse) - Maximal score is 54
Time Frame
At 4 months
Title
both parents' perception of social support
Description
assessed with Social Support Scale (SSQ) Minimal score is 0 (worse) - Maximal score is 54
Time Frame
At 12 months
Title
both parents' perception of their marital relationship
Description
assessed with Dyadic Adjustment Scale (DAS) Minimal score is 16 (worse) - Maximal score is 96
Time Frame
At 4 months
Title
both parents' perception of their marital relationship
Description
assessed with Dyadic Adjustment Scale (DAS) Minimal score is 16 (worse) - Maximal score is 96
Time Frame
At 12 months
Title
both parents' bonding to the child
Description
assessed with Post-partum Bonding questionnaire (PBQ). Minimal score is 0 - Maximal score is 125 (worse)
Time Frame
At 4 months
Title
both parents' bonding to the child
Description
assessed with Post-partum Bonding questionnaire (PBQ). Minimal score is 0 - Maximal score is 125 (worse)
Time Frame
At 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bérengère BEAUQUIER-MACCOTTA, MD
Phone
+33 6 62 17 62 92
Email
b.beauquier@epsve.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laure CHOUPEAUX, Master
Phone
+33 1 44 38 17 11
Email
laure.choupeaux@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bérengère BEAUQUIER-MACCOTTA, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25 000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauriane VULLIEZ, MD, PhD
Phone
+33 3 81 21 81 54
Email
lvulliez@chu-besancon.fr
Facility Name
CHU - Maternité
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajeev RAMANAH, MD, PhD
Facility Name
Centre hospitalier Intercommunal André Grégoire
City
Montreuil
ZIP/Postal Code
93100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno RENEVIER, MD
Facility Name
Etablissement Ville Evrard
City
Noisy-le-Sec
ZIP/Postal Code
93130
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bérengère BEAUQUIER-MACCOTTA, MD, PhD
Phone
+33 6 62 17 62 92
Email
b.beauquier@epsve.fr
Facility Name
Centre hospitalier Saint Anne
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain DUGRAVIER, MD
Phone
+33 1 45 65 64 80
Facility Name
Hôpital Saint Joseph - Maternité
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elie AZRIA, MD, PhD
Facility Name
Hôpital Necker - Enfants malades - pedospychiatrie
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa OUSS, MD
Phone
+33 1 44 49 45 61
Email
lisa.ouss@aphp.fr
Facility Name
Hôpital Necker - Maternity
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves VILLE, MD, PhD
Facility Name
CHRU Reims
City
Reims
ZIP/Postal Code
51000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie AUER, MD
Phone
+33 3 82 24 15 15
Email
jauer@chu-reims.fr
Facility Name
Centre hospitalier - unité de périnalité
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-catherine ROLLAND, MD, PhD
First Name & Middle Initial & Last Name & Degree
Julie AUER, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress
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