Text Size

Fathers and Late Preterm Babies Study (FLPTB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT01056653
First received: January 22, 2010
Last updated: January 25, 2010
Last verified: January 2010
History of Changes
  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:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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 ]

Estimated Enrollment: 180
Study Start Date: March 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (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

Contacts
Contact: Karen M Benzies, PhD 403-220-2294 benzies@ucalgary.ca
Contact: Joyce Magill-Evans, PhD 403-492-0402 joyce.magill-evans@ualberta.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Karen M Benzies, PhD     403-220-2294     benzies@ucalgary.ca    
Principal Investigator: Karen M Benzies, PhD            
Sub-Investigator: Wendy Yee, MD, MSc            
Sub-Investigator: Laurie Blahitka, MN            
Sub-Investigator: Alberto Nettel-Aguirre, PhD            
Sub-Investigator: Shirley Leew, PhD            
Sub-Investigator: Joyce MaGill-Evans, PhD            
Sponsors and Collaborators
University of Calgary
  More Information

Additional Information:
Study information for potential participants  This link exits the ClinicalTrials.gov site

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, Associate Professor, Faculty of Nursing, 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: January 25, 2010
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 May 23, 2013