Fathers and Late Preterm Babies Study (FLPTB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Benzies, University of Calgary
ClinicalTrials.gov Identifier:
NCT01056653
First received: January 22, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to test an educational intervention for first-time fathers of late preterm (34 to 36 weeks gestation) infants.


Condition Intervention
Infant, Premature
Behavioral: Standard Dose
Behavioral: High Dose
Behavioral: Comparison Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fathers and Late Preterm Babies Study: Effects of an Educational Intervention on Fathers' Interactions With Infants Born Between 34 and 36 Weeks Gestation

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Father-infant interaction [ Time Frame: When the infant is 8 months old, adjusting for prematurity ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parenting stress [ Time Frame: When the infant is 8 months old, adjusting for prematurity ] [ Designated as safety issue: No ]
  • Perceived quality of parenting [ Time Frame: When the infant is 8 months old, adjusting for prematurity ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: March 2009
Study Completion Date: January 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Teal
Two intervention home visits
Behavioral: Standard Dose
Two home visits
Experimental: Group B Purple
Four home visits
Behavioral: High Dose
Four home visits
Sham Comparator: Group C Yellow
Comparison Group (information only)
Behavioral: Comparison Group
One home visit, information only

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fathers - first-time father, 18 years or older, speak and read English, live with the child's other parent, live within one hours' drive of the university
  • Infants - less than 4 months old, singleton

Exclusion Criteria:

  • Fathers - known addictions
  • Infants - one of a multiple birth, required assisted ventilation, had culture-proven sepsis, major surgical procedure, identified major congenital anomalies, chromosomal anomalies, intracranial hemorrhage, neurologic disorder, or perinatal asphyxia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056653

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
  More Information

Additional Information:
Publications:
Magill-Evans, J., Harrison, M. J., Benzies, K. M., Gierl, M., & Kimak, C. (2007). Effects of parenting education on first-time fathers' skills in interactions with their infants. Fathering, 5, 42-57.

Responsible Party: Karen Benzies, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01056653     History of Changes
Other Study ID Numbers: E-21846, ACCFCR Grant # 0802INV-Benzies
Study First Received: January 22, 2010
Last Updated: July 29, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
father-child relations
paternal behaviour
early intervention
child-rearing

ClinicalTrials.gov processed this record on April 17, 2014