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

NCT04916938 | Completed

• 2 other identifiers: APHP180615ID-RCB Number
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 10

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.

Conditions

Post-traumatic Stress Disorder (PTSD)

Keywords

Post-Natal Post-traumatic Stress Disorder (PN-PTSD); Interactive guidance therapy; Video feedback

Outcome Measures

Primary Outcomes (1)

• Maternal sensitivity

  Evaluate by Coding Interactive Behaviour (CIB)

  At 4 months

Secondary Outcomes (19)

• Maternal sensitivity at 12 months

  At 12 months

• Prevalence of PN-PTSD

  At 4 months

• Prevalence of PN-PTSD

  At 12 months

• Prevalence of post natal depressive symptoms

  At 4 months

• Prevalence of post natal depressive symptoms

  At 12 months

Study Arms (2)

Interactive Guidance Therapy

EXPERIMENTAL

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; Behavioral: Interview; Behavioral: Self-rated questionnaires

Treatment as usual

ACTIVE COMPARATOR

Mother child psychotherapeutic sessions without video feed back.

Behavioral: Mother's child psychotherapeutic session; Behavioral: Interview; Behavioral: Self-rated questionnaires

Interventions

Interaction Guidance Therapy BEHAVIORAL

Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.

Interactive Guidance Therapy

Mother's child psychotherapeutic session BEHAVIORAL

Mother's representation of the event, mother's representation of the relation to her child, maternal emotions.

Treatment as usual

Interview BEHAVIORAL

History and perception of the mother's issues.

Interactive Guidance Therapy; Treatment as usual

Self-rated questionnaires BEHAVIORAL

Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child

Interactive Guidance Therapy; Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (10)

CHU Besançon

Besançon, 25 000, France

Location

CHU - Maternité

Besançon, 25000, France

Location

Centre hospitalier Intercommunal André Grégoire

Montreuil, 93100, France

Location

Etablissement Ville Evrard

Noisy-le-Sec, 93130, France

Location

Centre hospitalier Saint Anne

Paris, 75014, France

Location

Hôpital Saint Joseph - Maternité

Paris, 75014, France

Location

Hôpital Necker - Enfants malades - pedospychiatrie

Paris, 75015, France

Location

Hôpital Necker - Maternity

Paris, 75015, France

Location

CHRU Reims

Reims, 51000, France

Location

Centre hospitalier - unité de périnalité

Reims, 51100, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Bérengère BEAUQUIER-MACCOTTA, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: June 8, 2021
• Study Start: December 29, 2021
• Primary Completion: December 19, 2024
• Study Completion: May 13, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)