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

Primary Purpose

Preterm Birth, Parenting, Mental Health Wellness 1

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Triadic parent-infant Relationship Therapy (TRT)
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Intervention program, Parenting stress, Parental mental health, Preterm infant's development

Eligibility Criteria

28 Weeks - 35 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    No Intervention

    No Intervention

    Arm Label

    Preterm intervention TRT group

    Preterm control group

    Full-term control group

    Arm Description

    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

    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

    Parents with full-term infants without intervention program TRT

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Change in "Parental Mental Health" assessed by Post-Traumatic Stress Disorder (PTSD) scores: assessing level of post-traumatic stress
    Change in "Parental Mental Health" assessed by Beck Depression Inventory (BDI) scores: assessing level of depression
    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.
    "Infant Development" assessed by the Neonatal Behavioral Assessment Scale (NBAS) scores: assessing the baby's neurobehavioral development
    Change in "Infant Development"assessed by the Brunet-Lezine Psychomotor Development Scales: assessing developmental quotient (DQ)
    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.

    Full Information

    First Posted
    February 5, 2015
    Last Updated
    March 16, 2015
    Sponsor
    University Hospital, Caen
    Collaborators
    Ministry of Health, France, Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02394444
    Brief Title
    Impact of an Intervention Program on Parenting Stress After Preterm Birth
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    February 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Caen
    Collaborators
    Ministry of Health, France, Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth, Parenting, Mental Health Wellness 1, Parent-Child Relation, Child Development
    Keywords
    Intervention program, Parenting stress, Parental mental health, Preterm infant's development

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    89 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Preterm intervention TRT group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Preterm control group
    Arm Type
    No Intervention
    Arm Description
    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
    Arm Title
    Full-term control group
    Arm Type
    No Intervention
    Arm Description
    Parents with full-term infants without intervention program TRT
    Intervention Type
    Other
    Intervention Name(s)
    Triadic parent-infant Relationship Therapy (TRT)
    Other Intervention Name(s)
    TRT
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    "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
    Description
    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.
    Time Frame
    assessment at the corrected age of 18 months
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    Change in "Parental Mental Health" assessed by Edinburgh Postnatal Depression Scale (EPDS) scores: assessing level of postpartum depression
    Description
    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.
    Time Frame
    assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months
    Title
    "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
    Title
    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
    Title
    Change in "Infant Development"assessed by Infant Behavioral Symptom scores:assessing scores behaviors and emotional capabilities
    Description
    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.
    Time Frame
    assessments at each time point: at the corrected ages of 9 and 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Weeks
    Maximum Age & Unit of Time
    35 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bernard Guillois, PhD
    Organizational Affiliation
    Neonatology Department, Hospital and university center, Caen
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sophie Castel, MD
    Organizational Affiliation
    Neonatology Department, Hospital and university center, Caen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22884746
    Citation
    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.
    Results Reference
    background
    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.
    Results Reference
    background
    Citation
    This study was submitted at the 52nd Annual Meeting of the European Society for Pediatric Research at Newcastle (october 15-17th 2011)
    Results Reference
    background
    Citation
    This study was presented in Communication at the 42nd Journées Nationales de Néonatologie in Paris, march 2012.
    Results Reference
    background

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    Impact of an Intervention Program on Parenting Stress After Preterm Birth

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