HUGS
BehavioralGroup therapy with the participation of two therapist positively encouraging mother-baby interactions in a non-judgmental manner
NCT Number: NCT05209789
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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Notify Me18 year–100 year
Female
Interventional
Not applicable
Bordeaux Public Hospital, Bordeaux, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
regarding the mother:
Inclusion criteria
for the baby:
Non-inclusion criteria concerning the mother:
Non-inclusion criteria for the baby:
Group therapy with the participation of two therapist positively encouraging mother-baby interactions in a non-judgmental manner
Very little intervention from the therapists
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.
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.
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.
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.
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).
University Hospital, Toulouse
Other
HUGS : Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression: A Randomized Comparative Trial of the Cognitive Behavioral Therapy Program
Acronym: HUGS
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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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