Impact of an Intervention Program on Parenting Stress After Preterm Birth (IDEX)

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Parenting; Mental Health Wellness 1; Child Development; Parent-Child Relation
• Intervention / Treatment: Other: Triadic parent-infant Relationship Therapy (TRT)

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preterm intervention TRT group; Parents with premature infants received the intervention called "Triadic parent-infant's Relationship Therapy" (TRT) : the psychological intervention included home visits twice month during the first four months and then monthly visits in the neonatal ward until the 18 months corrected age resulting in a total of 22 visits during the whole intervention; TRT gave attention to emotional distress and the promotion of parenting skills and attachment security; The three sessions of intervention targeted objectives specific to each child's development; A basic manual was designed to ensure uniformity of the defined themes during each session	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.; Other Names: TRT
No Intervention: Preterm control group; Parents with premature infants without intervention program TRT (Triadic parent-infant's Relationship Therapy) received routine follow-up medical care with monthly visits to a practitioner for the first six months and then very three months
No Intervention: Full-term control group; Parents with full-term infants without intervention program TRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
"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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
"Infant Development" assessed by the Neonatal Behavioral Assessment Scale (NBAS) scores: assessing the baby's neurobehavioral development		assessments at 44 weeks gestational age
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer; Ministry of Health, France
• Investigators: Principal Investigator: Bernard Guillois, PhD, Neonatology Department, Hospital and university center, Caen; Principal Investigator: Sophie Castel, MD, Neonatology Department, Hospital and university center, Caen

Publications and helpful links

General Publications

• 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.
• 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 submitted at the 52nd Annual Meeting of the European Society for Pediatric Research at Newcastle (october 15-17th 2011)
• This study was presented in Communication at the 42nd Journées Nationales de Néonatologie in Paris, march 2012.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 20, 2015

Study Record Updates

• Last Update Posted (Estimate): March 20, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Intervention program; Parenting stress; Parental mental health; Preterm infant's development
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 05-094; 2006/0215 (Registry Identifier: DGS); 2005-36 (Registry Identifier: CPP)