Clinical trial NCT07017621: Qualitative Study on the Experiences of Mothers 6 to 12 Months After Their Participation in the Mother-baby Groups of the HUGS Study
Official title: Qualitative Study on the Experiences of Mothers 6 to 12 Months After Their Participation in the Mother-baby Groups of the HUGS Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postnatal Depression
Postpartum Depression (PPD)
Keywords: Postpartum Depression
mother-child interaction
early intervention
mother-baby interaction
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study participants are drawn from a clinical cohort of mothers who attended HUGS mother-baby groups at specialized maternity centers in France. Specifically, they represent patients from Toulouse University Hospital (Paule de Viguier Maternity), Joseph Ducuing Maternity in Toulouse, and Bordeaux Maternity. These women, must have completed the follow-up of the original HUGS study.

Brief summary: The HUGS-QUALI study is a qualitative investigation that explores the experiences of mothers who participated in HUGS mother-baby therapy groups. Conducted 6 to 12 months after the intervention, the study aims to understand how this culturally adapted therapy influences the bond between mothers and their infants and affects their daily lives. By collecting detailed personal stories through in-depth interviews, the study seeks to understand if the adapted HUGS program effectively support French mothers in improving their interactions with their babies, when facing postpartum depression.

Detailed description: Postpartum depression affects 15-20% of women in France and is often associated with impaired mother-infant interactions, a disruption observed in up to 73% of cases that can adversely influence both short and long-term child development. Although standard treatments effectively reduce depressive symptoms, they frequently fail to enhance the quality of the maternal bond, underscoring the need for interventions specifically targeted at early relational dynamics. The HUGS program (Happiness, Understanding, Giving, and Sharing), a brief cognitive behavioral therapy originally validated by Professor Jeannette Milgrom's Australian team, has been culturally adapted for the French context to improve mother-infant relationships. The ancillary HUGS-QUALI study employs a qualitative approach by conducting in-depth interviews with mothers 6 to 12 months following their participation in HUGS mother-baby groups, implemented across several French maternity centers.

Eligibility criteria: Inclusion Criteria:

* Women who participated in the HUGS mother-baby groups of the HUGS study (at various recruitment sites: Toulouse University Hospital (Paule de Viguier Maternity), Joseph Ducuing Maternity in Toulouse, and Bordeaux Maternity) and who have completed their follow-up as part of the original study.

Exclusion Criteria:

* Women refusing to participate in the study.
* Women who did not participate in the HUGS group of the HUGS study.

Primary outcomes:
measure: Qualitative Analysis of Maternal Narratives Reflecting the Impact of the Intervention on the Mother-Infant Relationship
timeFrame: 6 to 12 months after completion of the HUGS mother-baby therapy groups.
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Paule De Viguier Hospital
state: Occitanie
city: Bordeaux
country: France
facility: Bordeaux Public Hospital
city: Toulouse
country: France
facility: Joseph Ducuing
Study officials:
References: