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

Post-traumatic Stress Disorder (PTSD) Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916938
• Other study ID #: APHP180615
• Secondary ID: ID-RCB Number
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2021
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bérengère BEAUQUIER-MACCOTTA, MD
• Phone: +33 6 62 17 62 92
• Email: b.beauquier[@]epsve.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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