Clinical trial NCT02394444: Impact of an Intervention Program on Parenting Stress After Preterm Birth
Official title: Impact of a Psychological Post-hospital Intervention Aimed at Facilitating Parents-child Attachment and Preventing the Preterm Infants' Psycho-emotional, Social and Cognitive Disturbances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Parenting
Mental Health Wellness 1
Parent-Child Relation
Child Development
Keywords: Intervention program
Parenting stress
Parental mental health
Preterm infant's development
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2015-03-20
Enrollment: 89
Sex: ALL
Minimum age (years): 28
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study was to assess the impact of an early psychological intervention, Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental health, and preterm infant development in the motor, cognitive, emotional and behavioral domains at a corrected age of 18 months.

Detailed description: Due to prematurity induced infant-mother separation at birth, sometimes for several weeks, and owing to the concerns it generates, preterm birth exposes the parent-child attachment link to disturbances, especially the mother-child attachment after discharge. Several psychological factors affect infant (distress, dysmaturity ) and parents (psychological pain). These can cause lasting parent-child interactions disruption and jeopardize the attachment process. These early link distortions may hinder the infant's behavioral-emotional and cognitive development. Prematurity psychological consequences may negatively influence biomedical risks. Understanding these premature infants' future development modalities and support involves taking into account intricate organic and psychological factors - which may be combined as well.

Post-hospital psychological intervention with the family, focusing on parental mental health and triadic parent-infant relationship, proves an essential element in these children care, whose birth conditions were painful.

Eligibility criteria: Inclusion Criteria:

* Enrolled preterm infant were required to be between 28 and 35 weeks gestational age +6 days
* Enrolled the parents were required to be French speakers, over 18 years old and residing within 50-kilometres radius of hospital

Exclusion Criteria:

* preterm infant without congenital anomalies or any other foreseeable disabilities during the neonatal period
* parents without known psychiatric history

Primary outcomes:
measure: Change in the "Parent-Infant Relationship" assessed by Parenting Stress Index ( PSI-SF) scores : assessing level of stress in parenting
timeFrame: assessments at each time point: at the corrected ages of 3 and 18 months
measure: Change in "Parent-Infant Relationship" assessed by "R" interview scores : assessing level of parental self-esteem
timeFrame: assessments at each time point: at the corrected ages of 3 and 18 months
measure: "Parent-Infant Relationship" assessed by Q-sort attachment scores : assessing the score of the attachment security of the infant at the corrected age of 18 months
timeFrame: assessment at the corrected age of 18 months
Secondary outcomes:
measure: Change in "Parental Mental Health" assessed by Post-Traumatic Stress Disorder (PTSD) scores: assessing level of post-traumatic stress
timeFrame: assessments at each time point: at 44 weeks gestational age and at the corrected age of 18 months
measure: Change in "Parental Mental Health" assessed by Beck Depression Inventory (BDI) scores: assessing level of depression
timeFrame: assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months
measure: Change in "Parental Mental Health" assessed by Edinburgh Postnatal Depression Scale (EPDS) scores: assessing level of postpartum depression
timeFrame: assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months
measure: "Infant Development" assessed by the Neonatal Behavioral Assessment Scale (NBAS) scores: assessing the baby's neurobehavioral development
timeFrame: assessments at 44 weeks gestational age
measure: Change in "Infant Development"assessed by the Brunet-Lezine Psychomotor Development Scales: assessing developmental quotient (DQ)
timeFrame: assessments at each time point: at the corrected ages of 3, 9 and 18 months
measure: Change in "Infant Development"assessed by Infant Behavioral Symptom scores:assessing scores behaviors and emotional capabilities
timeFrame: assessments at each time point: at the corrected ages of 9 and 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Neonatology Department, Hospital and university center, Caen
name: Bernard Guillois, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neonatology Department, Hospital and university center, Caen
name: Sophie Castel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guillois B, Castel S, Beunard A, Blaizot X, Creveuil C, Proia-Lelouey N. [Effect of early intervention programs on neurobehavioral outcome in premature infants after discharge]. Arch Pediatr. 2012 Sep;19(9):990-7. doi: 10.1016/j.arcped.2012.06.004. Epub 2012 Aug 9. French.
citation: Sizun, J., Guillois, B., Casper, C., Thiriez, G., Kuhn, P. 2014.Soins de développement en période néonatale.De la recherche à la pratique. Springer.
citation: This study was submitted at the 52nd Annual Meeting of the European Society for Pediatric Research at Newcastle (october 15-17th 2011)
citation: This study was presented in Communication at the 42nd Journées Nationales de Néonatologie in Paris, march 2012.