NCT07017621

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2026

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

May 20, 2025

Last Update Submit

June 3, 2025

Conditions

Keywords

Postpartum Depressionmother-child interactionearly interventionmother-baby interaction

Outcome Measures

Primary Outcomes (1)

  • Qualitative Analysis of Maternal Narratives Reflecting the Impact of the Intervention on the Mother-Infant Relationship

    Qualitative thematic analysis of interview transcripts (no specific scale nor questionnaire) the semi directive interview guideline is confidential. Each interview will undergo multiple readings to identify emerging themes and sub-themes. The thematic framework will be validated through coding triangulation to ensure consistency and reliability of the findings.

    6 to 12 months after completion of the HUGS mother-baby therapy groups.

Study Arms (1)

Mother-baby group who received the HUGS therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Paule De Viguier Hospital

Toulouse, Occitanie, 31300, France

RECRUITING

Bordeaux Public Hospital

Bordeaux, France

RECRUITING

Joseph Ducuing

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2025

First Posted

June 12, 2025

Study Start

February 4, 2025

Primary Completion

February 4, 2026

Study Completion

February 4, 2026

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations