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

Post Partum Depression Clinical Trial

— HUGS  

Official title:

HUGS : Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression: A Randomized Comparative Trial of the Cognitive Behavioral Therapy Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209789
• Other study ID #: RC31/21/0166
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: University Hospital, Toulouse
• Contact: Carole GENTILLEAU, MD
• Phone: 33-5 61 77 13 15
• Email: gentilleau.c[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Post-partum depression (PPD) is the most common psychological pathology following childbirth and affects 12% of women in France. This pathology may impair the mother-infant relationship and lead to suboptimal development of the baby in the short and long-term. The prevalence of early interaction disorders is estimated at 73% among women suffering from PPD. Although treatments for PDD are effective, the mother-infant interaction remains impaired, as well as the short, medium and long-term development of the child. It is therefore essential to develop at a very early stage an intervention specifically targeting the mother-infant interaction, and to integrate this care into the general care given to mothers suffering from PPD.

A short cognitive-behavioural therapy intervention focused on improving the quality of the mother-infant relationship (the HUGS program: Happiness, Understanding, Giving and Sharing) has been created and validated by Prof. Jeannette Milgrom's Australian team. The objective of our study is to evaluate the effectiveness of the HUGS programme compared to a Playtime control group using a randomised controlled trial in a population of women suffering from PPD and being cared for in 7 French maternity hospitals. The comparison will be made 6 months after intervention initiation using "Factor 1: Mother Positive Affective Involvement and Verbalization" of the PCERA (Parent-Child Early Relational Assessment) mother-child interaction evaluation scale.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post Partum Depression

Intervention

Behavioral:
• HUGS
Group therapy with the participation of two therapist positively encouraging mother-baby interactions in a non-judgmental manner
• Playtime
Very little intervention from the therapists

Locations

Country	Name	City	State
France	Bordeaux Public Hospital	Bordeaux
France	Havre Public Hospital Maternity	Le Havre
France	Reims Public Hospital Maternity	Reims
France	Rouen Public Hospital Maternity	Rouen
France	Toulouse Child Guidance	Toulouse
France	Toulouse Joseph Ducuing Maternity	Toulouse
France	Toulouse Public Hospital Maternity	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socio-economic analysis	the efficiency of the HUGS program compared to usual care, by means of a cost-utility analysis: Costs of support from the point of view of the community and QALYs in order to calculate a differential cost-utility ratio (collected using the EUROQOL EQ-5D-5L scale).	6 months after the end of the intervention
Primary	Mother-infant interaction	The primary endpoint will be the score of factor 1 ("positive affective commitment of the mother as well as her verbalization skills with her baby") of the mother-baby interaction assessment scale The Parent-Child Early Relational Assessment ( PCERA) between the two study groups : HUGS and Playtime.; PCERA factor 1 will be measured by analysis of video footage of each mother-baby duo by two independent blind assessors from allocation groups.The score taken into account will be the consensus score between the two evaluators.	6 months after the end of the intervention
Secondary	Mothers' stress	Parental Stress Index (PSI-3) measured on both groups. This index is categorised in various items (stressors), each including a Likert style index from 1 to 5. The PSI-3 sums up all the items into a score : a high score representing a high stress for the parent.	Right before the intervention (Baseline)
Secondary	Mothers' stress	Parental Stress Index (PSI-3) measured on both groups. This index is categorised in various items (stressors), each including a Likert style index from 1 to 5. The PSI-3 sums up all the items into a score : a high score representing a high stress for the parent.	Right at the end of the intervention : 28 days after the start of the study
Secondary	Mothers' stress	Parental Stress Index (PSI-3) measured on both groups. This index is categorised in various items (stressors), each including a Likert style index from 1 to 5. The PSI-3 sums up all the items into a score : a high score representing a high stress for the parent.	6 months after the end of the intervention