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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-traumatic Stress Disorder (PTSD)
• Intervention / Treatment: Behavioral: Interaction Guidance Therapy; Behavioral: Interview; Behavioral: Self-rated questionnaires; Behavioral: Mother's child psychotherapeutic session

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)

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bérengère BEAUQUIER-MACCOTTA, MD; Phone Number: +33 6 62 17 62 92; Email: b.beauquier@epsve.fr

Study Locations

• France
  • Besançon, France, 25 000
    • Recruiting
    • CHU Besançon
    • Contact: Lauriane VULLIEZ, MD, PhD; Phone Number: +33 3 81 21 81 54; Email: lvulliez@chu-besancon.fr
  • Besançon, France, 25000
    • Not yet recruiting
    • CHU - Maternité
    • Contact: Rajeev Ramanah, MD, PhD
  • Montreuil, France, 93100
    • Not yet recruiting
    • Centre hospitalier Intercommunal André Grégoire
    • Contact: Bruno RENEVIER, MD
  • Noisy-le-Sec, France, 93130
    • Not yet recruiting
    • Etablissement Ville Evrard
    • Contact: Bérengère BEAUQUIER-MACCOTTA, MD, PhD; Phone Number: +33 6 62 17 62 92; Email: b.beauquier@epsve.fr
  • Paris, France, 75014
    • Not yet recruiting
    • Centre Hospitalier Saint Anne
    • Contact: Romain DUGRAVIER, MD; Phone Number: +33 1 45 65 64 80
  • Paris, France, 75014
    • Not yet recruiting
    • Hôpital Saint Joseph - Maternité
    • Contact: Elie AZRIA, MD, PhD
  • Paris, France, 75015
    • Recruiting
    • Hôpital Necker - Enfants malades - pedospychiatrie
  • Paris, France, 75015
    • Not yet recruiting
    • Hôpital Necker - Maternity
    • Contact: Yves VILLE, MD, PhD
  • Reims, France, 51000
    • Recruiting
    • CHRU Reims
    • Contact: Julie AUER, MD; Phone Number: +33 3 82 24 15 15; Email: jauer@chu-reims.fr
  • Reims, France, 51100
    • Not yet recruiting
    • Centre hospitalier - unité de périnalité
    • Contact: Anne-catherine ROLLAND, MD, PhD
    • Principal Investigator: Julie AUER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Behavioral: Interview; History and perception of the mother's issues.; Behavioral: Self-rated questionnaires; Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child
Active Comparator: Treatment as usual; Mother child psychotherapeutic sessions without video feed back.	Behavioral: Interview; History and perception of the mother's issues.; Behavioral: Self-rated questionnaires; Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child; Behavioral: Mother's child psychotherapeutic session; Mother's representation of the event, mother's representation of the relation to her child, maternal emotions.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Bérengère BEAUQUIER-MACCOTTA, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Interactive guidance therapy; Post-Natal Post-traumatic Stress Disorder (PN-PTSD); Video feedback
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Psychotropic Drugs
• Other Study ID Numbers: APHP180615; ID-RCB Number (Other Identifier: 2020-A02576-33)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No