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Impact of an Intervention Program on Parenting Stress After Preterm Birth

Impact of a Psychological Post-hospital Intervention Aimed at Facilitating Parents-child Attachment and Preventing the Preterm Infants' Psycho-emotional, Social and Cognitive Disturbances

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02394444
Acronym
IDEX
Enrollment
89
Registered
2015-03-20
Start date
2006-06-30
Completion date
2010-02-28
Last updated
2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development, Mental Health Wellness 1, Parent-Child Relation, Parenting, Preterm Birth

Keywords

Intervention program, Parenting stress, Parental mental health, Preterm infant's development

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.

Interventions

OTHERTriadic parent-infant Relationship Therapy (TRT)

22 sessions, including home visits twice per month during the first four months, followed by monthly consultations in the neonatology ward, up to corrected age of 18 months.

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Wyeth is now a wholly owned subsidiary of Pfizer
CollaboratorINDUSTRY
University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 35 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the Parent-Infant Relationship assessed by Parenting Stress Index ( PSI-SF) scores : assessing level of stress in parentingassessments at each time point: at the corrected ages of 3 and 18 months
Change in Parent-Infant Relationship assessed by R interview scores : assessing level of parental self-esteemassessments at each time point: at the corrected ages of 3 and 18 months
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 monthsassessment at the corrected age of 18 monthsWe needed to use a variety of measures because these measures had to be tailored to the child's stage of development. To ensure the relative strength conclusion on the treatment effect, the statistic analyses of test scores each time point were made using bonefferoni correction for multiple comparisons. Parenting Stress Index ( PSI-SF), R interview and Q-sort attachment were tests based on the infant's age at different assessment periods.

Secondary

MeasureTime frameDescription
Infant Development assessed by the Neonatal Behavioral Assessment Scale (NBAS) scores: assessing the baby's neurobehavioral developmentassessments at 44 weeks gestational age
Change in Parental Mental Health assessed by Post-Traumatic Stress Disorder (PTSD) scores: assessing level of post-traumatic stressassessments at each time point: at 44 weeks gestational age and at the corrected age of 18 months
Change in Infant Developmentassessed by Infant Behavioral Symptom scores:assessing scores behaviors and emotional capabilitiesassessments at each time point: at the corrected ages of 9 and 18 monthsThe statistic analyses were used to compare the evolution of all of the other scores over time. The Neonatal Behavioral Assessment Scale (NBAS),the Brunet-Lezine Psychomotor Development Scale and Infant Behavioral Symptom were tests that were complementary and enable us to assess infant's various facets of socio-emotional, motor and cognitive development at different stage of development.
Change in Infant Developmentassessed by the Brunet-Lezine Psychomotor Development Scales: assessing developmental quotient (DQ)assessments at each time point: at the corrected ages of 3, 9 and 18 months
Change in Parental Mental Health assessed by Beck Depression Inventory (BDI) scores: assessing level of depressionassessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months
Change in Parental Mental Health assessed by Edinburgh Postnatal Depression Scale (EPDS) scores: assessing level of postpartum depressionassessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 monthsThe BDI and the EPDS are both based on the frequency of depressive symptoms The statistic analyses were used to compare the evolution of all of the other scores over time. The Post-Traumatic Stress Disorder (PTSD), Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS) were tests that were resorted to enable us to examine and monitor the preterm birth traumatic impact on parental mental health.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026