Impact of an Intervention Program on Parenting Stress After Preterm Birth

NCT02394444

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Preterm Birth, Parenting, Mental Health Wellness 1, Parent-Child Relation, Child Development
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
28-35 weeks
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- preterm infant without congenital anomalies or any other foreseeable disabilities
during the neonatal period


- parents without known psychiatric history

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Preterm Birth, Parenting, Mental Health Wellness 1, Parent-Child Relation, Child DevelopmentImpact of an Intervention Program on Parenting Stress After Preterm Birth
NCT02394444
ALL GENDERS
28 Weeks+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Impact of an Intervention Program on Parenting Stress After Preterm Birth
Official Title  ICMJE Impact of a Psychological Post-hospital Intervention Aimed at Facilitating Parents-child Attachment and Preventing the Preterm Infants' Psycho-emotional, Social and Cognitive Disturbances
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Preterm Birth
  • Parenting
  • Mental Health Wellness 1
  • Parent-Child Relation
  • Child Development
Intervention  ICMJE 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 Name: TRT
Study Arms  ICMJE
  • 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

    Intervention: Other: Triadic parent-infant Relationship Therapy (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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2015)
89
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 28 Weeks to 35 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02394444
Other Study ID Numbers  ICMJE 05-094
2006/0215 ( Registry Identifier: DGS )
2005-36 ( Registry Identifier: CPP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE
  • Ministry of Health, France
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Bernard Guillois, PhDNeonatology Department, Hospital and university center, Caen
Principal Investigator:Sophie Castel, MDNeonatology Department, Hospital and university center, Caen
PRS Account University Hospital, Caen
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP