Trials / Recruiting
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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | HUGS | Group therapy with the participation of two therapist positively encouraging mother-baby interactions in a non-judgmental manner |
| BEHAVIORAL | Playtime | Very 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.