Postnatal DepressionHUGSqualiNCT07017621
Qualitative Study on the Experiences of Mothers 6 to 12 Months After Their Participation in the Mother-baby Groups of the HUGS Study
An observational study of Postnatal Depression and Postpartum Depression (PPD), run by University Hospital, Toulouse at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postnatal Depression, Postpartum Depression (PPD)
- How many people
- 12 participants
- Where
- 4 sitesFrance
- Study dates
- 4 Feb 2025to 4 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Women refusing to participate in the study.
- Women who did not participate in the HUGS group of the HUGS study.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Bordeaux Public Hospital
Bordeaux
Hopital Maison Blanche
Reims
Paule De Viguier Hospital
Toulouse, Occitanie, 31300
Joseph Ducuing
Toulouse
About this 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.
Read the 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.
- Conditions
- Postnatal Depression, Postpartum Depression (PPD)
- Keywords
- Postpartum Depression, mother-child interaction, early intervention, mother-baby interaction
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mother-baby group who received the HUGS therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 to 12 months after completion of the HUGS mother-baby therapy groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start4 Feb 2025
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017621
- Sponsor's protocol ID
- RC31/21/0166-ancillaire
- Other IDs
- 2024-A02604-43
- Acronym
- HUGSquali
- Status last verified
- May 2026
- First submitted
- 20 May 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07017621
- Acronym / sponsor ID
- HUGSquali / RC31/21/0166-ancillaire
- Conditions
- Postnatal Depression, Postpartum Depression (PPD)
- Keywords
- Postpartum Depression, mother-child interaction, early intervention, mother-baby interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother-baby group who received the HUGS therapy | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Women refusing to participate in the study.
- Women who did not participate in the HUGS group of the HUGS study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postnatal Depression and Postpartum Depression (PPD), run by University Hospital, Toulouse at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.