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Completed

NCT Number: NCT05209789

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux Public Hospital, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

HUGS

Behavioral

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

Playtime

Behavioral

Very little intervention from the therapists

Primary outcomes

  1. Mother-infant interaction

    Time frame: 6 months after the end of the intervention

    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.

Secondary outcomes

  1. Mothers' stress

    Time frame: Right before the intervention (Baseline)

    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.

  2. Mothers' stress

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

    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.

  3. Mothers' stress

    Time frame: 6 months after the end of the intervention

    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.

Other outcomes

  1. Socio-economic analysis

    Time frame: 6 months after the end of the intervention

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: HUGS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2022
Registry last updated
May 12, 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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