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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-18

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post Partum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, interregional, comparative, prospective therapeutic study in 2 parallel groups (1: 1), superiority, randomized, blinded for the evaluation of the primary endpoint.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

group attribution blinded to evaluators for the evaluation of the primary endpoint via video tapes

Study Groups

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HUGS therapy

A structured group intervention that aims to observe mother's behavior and responses with her baby, promote mother-baby interaction through play, and provide tools for positive interaction. This therapy involves cognitive and behavioral work. Therapists observe the mother-baby duo and share their observations from a perspective of encouragement and support. A playful and non-judgmental interaction is cultivated within the group. The main objective is to change the negative trajectory of mother-child interactions through tools from cognitive-behavioral therapies as well as using knowledge about child development.

Group Type EXPERIMENTAL

HUGS

Intervention Type BEHAVIORAL

Group therapy with the participation of two therapist positively encouraging mother-baby interactions in a non-judgmental manner

Playtime

The participants assigned to the control group will also be in the presence of two therapists, allowing to reproduce the framework of the HUGS therapy. The difference will be the lack of direct therapeutic intervention from the therapists, but only classic psychoeducational guidance. The mothers are offered a time to play with their baby as well as the opportunity to discuss and share their experiences with other mothers, which is generally seen as supportive by them.

Group Type ACTIVE_COMPARATOR

Playtime

Intervention Type BEHAVIORAL

Very little intervention from the therapists

Interventions

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HUGS

Group therapy with the participation of two therapist positively encouraging mother-baby interactions in a non-judgmental manner

Intervention Type BEHAVIORAL

Playtime

Very little intervention from the therapists

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

* Baby aged less than 1 year at inclusion;
* Twins will be able to participate in the study and benefit from the interventions;

* 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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No