CompletedNot Applicable

Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression

France104 participantsStarted 2023-12-18

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria regarding the mother: * Person affiliated or beneficiary of a social security plan; * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research); * Woman who gave birth in one of the maternity hospitals participating in the study; * Diagnosis of postpartum depression made by the perinatal psychiatry team according to the clinical criteria of the DSM-5; * Time to onset of depressive symptoms within the first 12 months after childbirth; * Treatment for postpartum depression that started at least 8 weeks ago with improved mood as assessed by the psychiatrist. Inclusion criteria for the baby: * Baby aged less than 1 year at inclusion; * Twins will be able to participate in the study and benefit from the interventions; Non-inclusion criteria concerning the mother: * Uncontrolled substance use disorder; * Presence of suicidal ideas at inclusion; * Manic episode of a bipolar disease * Psychiatric pathology decompensated upon inclusion and corresponding to the following list: Schizophrenic disorder, Schizoaffective disorder, Mood disorders with psychotic symptoms; * Non French speaker. Non-inclusion criteria for the baby: \- Baby hospitalized or having sustained medical care upon inclusion in the context of a somatic pathology.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mother-infant interaction

Timeframe: 6 months after the end of the intervention

Trial details

NCT IDNCT05209789

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-25

View on ClinicalTrials.gov More Post Partum Depression trials