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Completed

NCT Number: NCT07017621

Qualitative Study on the Experiences of Mothers 6 to 12 Months After Their Participation in the Mother-baby Groups of the HUGS Study

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Paule De Viguier Hospital, Toulouse, Occitanie, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: HUGSquali

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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