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

NCT05209789 | Recruiting

• 1 other identifier: RC31/21/0166
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Post Partum Depression

Keywords

Mother-baby interaction; Group therapy; Cognitive behavioral therapy; mother-infant relationship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mothers' stress

  Right before the intervention (Baseline)

• Mothers' stress

  Right at the end of the intervention : 28 days after the start of the study

• Mothers' stress

  6 months after the end of the intervention

Other Outcomes (1)

• Socio-economic analysis

  6 months after the end of the intervention

Study Arms (2)

HUGS therapy

EXPERIMENTAL

A structured group intervention that aims to observe mother's behavior and responses with her baby, promote mother-baby interaction through play, and provide tools for positive interaction. This therapy involves cognitive and behavioral work. Therapists observe the mother-baby duo and share their observations from a perspective of encouragement and support. A playful and non-judgmental interaction is cultivated within the group. The main objective is to change the negative trajectory of mother-child interactions through tools from cognitive-behavioral therapies as well as using knowledge about child development.

Behavioral: HUGS

Playtime

ACTIVE COMPARATOR

The participants assigned to the control group will also be in the presence of two therapists, allowing to reproduce the framework of the HUGS therapy. The difference will be the lack of direct therapeutic intervention from the therapists, but only classic psychoeducational guidance. The mothers are offered a time to play with their baby as well as the opportunity to discuss and share their experiences with other mothers, which is generally seen as supportive by them.

Behavioral: Playtime

Interventions

HUGS BEHAVIORAL

Group therapy with the participation of two therapist positively encouraging mother-baby interactions in a non-judgmental manner

HUGS therapy

Playtime BEHAVIORAL

Very little intervention from the therapists

Playtime

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Mothers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person affiliated or beneficiary of a social security plan;
• 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.
• Twins will be able to participate in the study and benefit from the interventions;
• Uncontrolled substance use disorder;
• Manic episode of a bipolar disease
• Non French speaker.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (7)

Bordeaux Public Hospital

Bordeaux, France

RECRUITING

Havre Public Hospital Maternity

Le Havre, France

RECRUITING

Reims Public Hospital Maternity

Reims, France

RECRUITING

Rouen Public Hospital Maternity

Rouen, France

RECRUITING

Toulouse Child Guidance

Toulouse, France

NOT YET RECRUITING

Toulouse Joseph Ducuing Maternity

Toulouse, France

NOT YET RECRUITING

Toulouse Public Hospital Maternity

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Carole GENTILLEAU, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carole GENTILLEAU, MD

CONTACT

33-5 61 77 13 15; gentilleau.c@chu-toulouse.fr

Isabelle KIEFFER, CRA

CONTACT

kieffer.i@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: group attribution blinded to evaluators for the evaluation of the primary endpoint via video tapes
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, interregional, comparative, prospective therapeutic study in 2 parallel groups (1: 1), superiority, randomized, blinded for the evaluation of the primary endpoint.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 27, 2022
• Study Start: December 18, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

FR (7)