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RecruitingNCT05209789

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

HUGS : Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression: A Randomized Comparative Trial of the Cognitive Behavioral Therapy Program

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
104 (estimated)
Sponsor
University Hospital, Toulouse · Academic / Other
Sex
Female
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHUGSGroup therapy with the participation of two therapist positively encouraging mother-baby interactions in a non-judgmental manner
BEHAVIORALPlaytimeVery little intervention from the therapists

Timeline

Start date
2023-12-18
Primary completion
2026-12-01
Completion
2026-12-01
First posted
2022-01-27
Last updated
2024-02-15

Locations

7 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05209789. Inclusion in this directory is not an endorsement.