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Completed

NCT Number: NCT02394444

Impact of an Intervention Program on Parenting Stress After Preterm Birth

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.

Completed

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Key information

Conditions

Preterm Birth Child Development Female Urogenital Diseases and Pregnancy Complications Mental Health Wellness 1 Obstetric Labor Complications Obstetric Labor, Premature Parent-Child Relation Parenting Pregnancy Complications Premature Birth Urogenital Diseases

Age range

28 week–35 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triadic parent-infant Relationship Therapy (TRT)

Other

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

Primary outcomes

  1. Change in the "Parent-Infant Relationship" assessed by Parenting Stress Index ( PSI-SF) scores : assessing level of stress in parenting

    Time frame: assessments at each time point: at the corrected ages of 3 and 18 months

  2. Change in "Parent-Infant Relationship" assessed by "R" interview scores : assessing level of parental self-esteem

    Time frame: assessments at each time point: at the corrected ages of 3 and 18 months

  3. "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

    Time frame: assessment 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.

Secondary outcomes

  1. Change in "Parental Mental Health" assessed by Post-Traumatic Stress Disorder (PTSD) scores: assessing level of post-traumatic stress

    Time frame: assessments at each time point: at 44 weeks gestational age and at the corrected age of 18 months

  2. Change in "Parental Mental Health" assessed by Beck Depression Inventory (BDI) scores: assessing level of depression

    Time frame: assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months

  3. Change in "Parental Mental Health" assessed by Edinburgh Postnatal Depression Scale (EPDS) scores: assessing level of postpartum depression

    Time frame: assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months

    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.

  4. "Infant Development" assessed by the Neonatal Behavioral Assessment Scale (NBAS) scores: assessing the baby's neurobehavioral development

    Time frame: assessments at 44 weeks gestational age

  5. Change in "Infant Development"assessed by the Brunet-Lezine Psychomotor Development Scales: assessing developmental quotient (DQ)

    Time frame: assessments at each time point: at the corrected ages of 3, 9 and 18 months

  6. Change in "Infant Development"assessed by Infant Behavioral Symptom scores:assessing scores behaviors and emotional capabilities

    Time frame: assessments at each time point: at the corrected ages of 9 and 18 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Ministry of Health, France
  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study 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

Acronym: IDEX

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Mar 20, 2015
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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