Impact of an Intervention Program on Parenting Stress After Preterm Birth

Preterm Birth Clinical Trial

— IDEX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394444
• Other study ID #: 05-094
• Secondary ID: 2006/02152005-36
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: March 16, 2015
• Start date: June 2006
• Est. completion date: February 2010

Study information

• Verified date: March 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 35 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Other:
• Triadic 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Caen	Ministry of Health, France, Wyeth is now a wholly owned subsidiary of Pfizer

References & Publications (4)

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. — View 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.

This study was presented in Communication at the 42nd Journées Nationales de Néonatologie in Paris, march 2012.

This study was submitted at the 52nd Annual Meeting of the European Society for Pediatric Research at Newcastle (october 15-17th 2011)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the "Parent-Infant Relationship" assessed by Parenting Stress Index ( PSI-SF) scores : assessing level of stress in parenting		assessments at each time point: at the corrected ages of 3 and 18 months	No
Primary	Change in "Parent-Infant Relationship" assessed by "R" interview scores : assessing level of parental self-esteem		assessments at each time point: at the corrected ages of 3 and 18 months	No
Primary	"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	We 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.	assessment at the corrected age of 18 months	No
Secondary	Change in "Parental Mental Health" assessed by Post-Traumatic Stress Disorder (PTSD) scores: assessing level of post-traumatic stress		assessments at each time point: at 44 weeks gestational age and at the corrected age of 18 months	No
Secondary	Change in "Parental Mental Health" assessed by Beck Depression Inventory (BDI) scores: assessing level of depression		assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months	No
Secondary	Change in "Parental Mental Health" assessed by Edinburgh Postnatal Depression Scale (EPDS) scores: assessing level of postpartum depression	The 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.	assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months	No
Secondary	"Infant Development" assessed by the Neonatal Behavioral Assessment Scale (NBAS) scores: assessing the baby's neurobehavioral development		assessments at 44 weeks gestational age	No
Secondary	Change in "Infant Development"assessed 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	No
Secondary	Change in "Infant Development"assessed by Infant Behavioral Symptom scores:assessing scores behaviors and emotional capabilities	The 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.	assessments at each time point: at the corrected ages of 9 and 18 months	No