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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


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
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