Impact of an Intervention Program on Parenting Stress After Preterm Birth

NCT02394444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2015-03-20

No results posted yet for this study

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.

Conditions

  • Preterm Birth
  • Parenting
  • Mental Health Wellness 1
  • Parent-Child Relation
  • Child Development

Interventions

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.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY
  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Bernard Guillois, PhD · Neonatology Department, Hospital and university center, Caen

  • Sophie Castel, MD · Neonatology Department, Hospital and university center, Caen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Weeks
Max Age
35 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2010-02-28
Completion
2010-02-28

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02394444 on ClinicalTrials.gov