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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014