Impact of an Intervention Program on Parenting Stress After Preterm Birth
NCT02394444
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- 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
- preterm infant without congenital anomalies or any other foreseeable disabilities
during the neonatal period
- parents without known psychiatric history
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Descriptive Information | |||||||
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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 |
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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 |
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Publications * |
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* 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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Investigators ICMJE |
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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 |