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

Not Applicable

Recruiting

• Conditions: Post Partum Depression
• Interventions: Behavioral: HUGS; Behavioral: Playtime

• Registration Number: NCT05209789
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-01-27
• Study Start: 2023-12-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HUGS therapy	HUGS	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.
Playtime	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.

Primary Outcome Measures

Name	Time	Method
Mother-infant interaction	6 months after the end of the intervention	The primary endpoint will be the score of factor 1 ("positive affective commitment of the mother as well as her verbalization skills with her baby") of the mother-baby interaction assessment scale The Parent-Child Early Relational Assessment ( PCERA) between the two study groups : HUGS and Playtime.; PCERA factor 1 will be measured by analysis of video footage of each mother-baby duo by two independent blind assessors from allocation groups.The score taken into account will be the consensus score between the two evaluators.

Secondary Outcome Measures

Name	Time	Method
Mothers' stress	6 months after the end of the intervention	Parental Stress Index (PSI-3) measured on both groups. This index is categorised in various items (stressors), each including a Likert style index from 1 to 5. The PSI-3 sums up all the items into a score : a high score representing a high stress for the parent.

Trial Locations

Locations (7)

Reims Public Hospital Maternity; 🇫🇷 Reims, France

Rouen Public Hospital Maternity; 🇫🇷 Rouen, France

Bordeaux Public Hospital; 🇫🇷 Bordeaux, France

Havre Public Hospital Maternity; 🇫🇷 Le Havre, France

Toulouse Child Guidance; 🇫🇷 Toulouse, France

Toulouse Joseph Ducuing Maternity; 🇫🇷 Toulouse, France

Toulouse Public Hospital Maternity; 🇫🇷 Toulouse, France