Post-traumatic Stress Disorder (PTSD)EVAGITNCT04916938
Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress
A study testing Interaction Guidance Therapy, Mother's child psychotherapeutic session and Interview in people with Post-traumatic Stress Disorder (PTSD), run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD)
- What is being tested?
- Interaction Guidance Therapy, Mother's child psychotherapeutic session and Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 10 sitesFrance
- Study dates
- 29 Dec 2021to 13 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Besançon
Besançon, 25 000
CHU - Maternité
Besançon, 25000
Centre hospitalier Intercommunal André Grégoire
Montreuil, 93100
Etablissement Ville Evrard
Noisy-le-Sec, 93130
Centre hospitalier Saint Anne
Paris, 75014
Hôpital Saint Joseph - Maternité
Paris, 75014
Hôpital Necker - Enfants malades - pedospychiatrie
Paris, 75015
Hôpital Necker - Maternity
Paris, 75015
CHRU Reims
Reims, 51000
Centre hospitalier - unité de périnalité
Reims, 51100
About this study
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.
Read more
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.
Read the 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)
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Being tested
- Interaction Guidance Therapy, Mother's child psychotherapeutic session, Interview, Self-rated questionnaires
- Keywords
- Post-Natal Post-traumatic Stress Disorder (PN-PTSD), Interactive guidance therapy, Video feedback
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interaction Guidance TherapyBehavioural
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 sessionBehavioural
Mother's representation of the event, mother's representation of the relation to her child, maternal emotions.
InterviewBehavioural
History and perception of the mother's issues.
Self-rated questionnairesBehavioural
Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Interaction Guidance Therapy; Behavioral: Interview; Behavioral: Self-rated questionnaires |
| Treatment as usual | Active comparator | Mother child psychotherapeutic sessions without video feed back. Receives: Behavioral: Mother's child psychotherapeutic session; Behavioral: Interview; Behavioral: Self-rated questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal sensitivity
Evaluate by Coding Interactive Behaviour (CIB)
Measured: At 4 months
Secondary outcomes (19)
Maternal sensitivity at 12 months
Evaluate by Coding Interactive Behaviour (CIB)
Measured: At 12 months
Prevalence of PN-PTSD
Evaluate by Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)
Measured: At 4 months
Prevalence of PN-PTSD
Evaluate by Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)
Measured: At 12 months
Prevalence of post natal depressive symptoms
Evaluation by Edinburgh post natal depression scale (EPDS)
Measured: At 4 months
Prevalence of post natal depressive symptoms
Evaluation by Edinburgh post natal depression scale (EPDS)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: At 12 months
Father's depressive symptoms
assessed with Edinburgh post natal depression scale (EPDS) Minimal score is 0 - Maximal score is 30 (worse)
Measured: At 4 months
Father's depressive symptoms
assessed with Edinburgh post natal depression scale (EPDS) Minimal score is 0 - Maximal score is 30 (worse)
Measured: At 12 months
both parents' anxiety
assessed with State Trait Anxiety Inventory (STAI) Minimal score is 20 - Maximal score is 80 (worse)
Measured: At 4 months
both parents' anxiety
assessed with State Trait Anxiety Inventory (STAI) Minimal score is 20 - Maximal score is 80 (worse)
Measured: At 12 months
both parents' perception of social support
assessed with Social Support Scale (SSQ) Minimal score is 0 (worse) - Maximal score is 54
Measured: At 4 months
both parents' perception of social support
assessed with Social Support Scale (SSQ) Minimal score is 0 (worse) - Maximal score is 54
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start29 Dec 2021
- Primary completion19 Dec 2024
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Bérengère BEAUQUIER-MACCOTTA, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916938
- Sponsor's protocol ID
- APHP180615
- Other IDs
- ID-RCB Number
- Acronym
- EVAGIT
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04916938
- Acronym / sponsor ID
- EVAGIT / APHP180615
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Keywords
- Post-Natal Post-traumatic Stress Disorder (PN-PTSD), Interactive guidance therapy, Video feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Guidance Therapy | Experimental | Behavioral: Interaction Guidance Therapy, Behavioral: Interview, Behavioral: Self-rated questionnairesMother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child. |
| Treatment as usual | Active comparator | Behavioral: Mother's child psychotherapeutic session, Behavioral: Interview, Behavioral: Self-rated questionnairesMother child psychotherapeutic sessions without video feed back. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interaction Guidance TherapyMother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child. | Behavioural | Interactive Guidance Therapy |
| Mother's child psychotherapeutic sessionMother's representation of the event, mother's representation of the relation to her child, maternal emotions. | Behavioural | Treatment as usual |
| InterviewHistory and perception of the mother's issues. | Behavioural | Interactive Guidance Therapy, Treatment as usual |
| Self-rated questionnairesParental Self-Questionnaire to assess the perception of the evolution of the father, mother and child | Behavioural | Interactive Guidance Therapy, Treatment as usual |
Primary outcome
Maternal sensitivity
Time frame: At 4 months
Evaluate by Coding Interactive Behaviour (CIB)
19 secondary outcomes
Maternal sensitivity at 12 months
Time frame: At 12 months
Prevalence of PN-PTSD
Time frame: At 4 months
Prevalence of PN-PTSD
Time frame: At 12 months
Prevalence of post natal depressive symptoms
Time frame: At 4 months
Prevalence of post natal depressive symptoms
Time frame: At 12 months
Infant development ASQ
Time frame: At 12 months
Infant symptoms SCL
Time frame: At 12 months
fathers' Post-traumatic stress disorder
Time frame: At 4 months
fathers' Post-traumatic stress disorder
Time frame: At 12 months
Father's depressive symptoms
Time frame: At 4 months
Father's depressive symptoms
Time frame: At 12 months
both parents' anxiety
Time frame: At 4 months
both parents' anxiety
Time frame: At 12 months
both parents' perception of social support
Time frame: At 4 months
both parents' perception of social support
Time frame: At 12 months
both parents' perception of their marital relationship
Time frame: At 4 months
both parents' perception of their marital relationship
Time frame: At 12 months
both parents' bonding to the child
Time frame: At 4 months
both parents' bonding to the child
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Post-traumatic Stress Disorder (PTSD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bérengère BEAUQUIER-MACCOTTA, MD principal investigator
Assistance Publique - Hôpitaux de Paris
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interaction Guidance Therapy, Mother's child psychotherapeutic session and Interview in people with Post-traumatic Stress Disorder (PTSD), run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal sensitivity (time frame: At 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.