Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression

Last updated: February 14, 2024
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

Playtime

HUGS

Clinical Study ID

NCT05209789
RC31/21/0166
  • Ages 18-100
  • Female

Study Summary

Postpartum depression (PPD) may impair the mother-infant relationship and lead to both short and long-term suboptimal development of the baby. This study aims to evaluate the effectiveness of a targeted intervention (HUGS: Happiness Understanding Giving and Sharing) for enhancing the mother-infant relationship.

Eligibility Criteria

Inclusion

Inclusion criteria regarding the mother:

  • Person affiliated or beneficiary of a social security plan;

  • Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);

  • Woman who gave birth in one of the maternity hospitals participating in the study;

  • Diagnosis of postpartum depression made by the perinatal psychiatry team according to the clinical criteria of the DSM-5;

  • Time to onset of depressive symptoms within the first 12 months after childbirth;

  • Treatment for postpartum depression that started at least 8 weeks ago with improved mood as assessed by the psychiatrist.

Inclusion criteria for the baby:

  • Baby aged less than 1 year at inclusion;

  • Twins will be able to participate in the study and benefit from the interventions;

Non-inclusion criteria concerning the mother:

  • Uncontrolled substance use disorder;

  • Presence of suicidal ideas at inclusion;

  • Manic episode of a bipolar disease

  • Psychiatric pathology decompensated upon inclusion and corresponding to the following list: Schizophrenic disorder, Schizoaffective disorder, Mood disorders with psychotic symptoms;

  • Non French speaker.

Non-inclusion criteria for the baby:

  • Baby hospitalized or having sustained medical care upon inclusion in the context of a somatic pathology.

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: Playtime
Phase:
Study Start date:
December 18, 2023
Estimated Completion Date:
December 31, 2026

Study Description

Post-partum depression (PPD) is the most common psychological pathology following childbirth and affects 12% of women in France. This pathology may impair the mother-infant relationship and lead to suboptimal development of the baby in the short and long-term. The prevalence of early interaction disorders is estimated at 73% among women suffering from PPD. Although treatments for PDD are effective, the mother-infant interaction remains impaired, as well as the short, medium and long-term development of the child. It is therefore essential to develop at a very early stage an intervention specifically targeting the mother-infant interaction, and to integrate this care into the general care given to mothers suffering from PPD.

A short cognitive-behavioural therapy intervention focused on improving the quality of the mother-infant relationship (the HUGS program: Happiness, Understanding, Giving and Sharing) has been created and validated by Prof. Jeannette Milgrom's Australian team. The objective of our study is to evaluate the effectiveness of the HUGS programme compared to a Playtime control group using a randomised controlled trial in a population of women suffering from PPD and being cared for in 7 French maternity hospitals. The comparison will be made 6 months after intervention initiation using "Factor 1: Mother Positive Affective Involvement and Verbalization" of the PCERA (Parent-Child Early Relational Assessment) mother-child interaction evaluation scale.

Connect with a study center

  • Bordeaux Public Hospital

    Bordeaux,
    France

    Active - Recruiting

  • Havre Public Hospital Maternity

    Le Havre,
    France

    Active - Recruiting

  • Reims Public Hospital Maternity

    Reims,
    France

    Active - Recruiting

  • Rouen Public Hospital Maternity

    Rouen,
    France

    Active - Recruiting

  • Toulouse Child Guidance

    Toulouse,
    France

    Site Not Available

  • Toulouse Joseph Ducuing Maternity

    Toulouse,
    France

    Site Not Available

  • Toulouse Public Hospital Maternity

    Toulouse,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.