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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: February 27, 2017
Last verified: February 2017
  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
Premature Birth Behavioral: Standard Dose Behavioral: High Dose Behavioral: Comparison Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Further study details as provided by Karen Benzies, University of Calgary:

Primary Outcome Measures:
  • Parent Child Interaction Teaching Scale (PCITS) [ Time Frame: When the infant was 8 months old, adjusting for prematurity ]

    Assesses parent-infant interaction skills. Used for children from birth to 3 years of age. It is an observational measure of the presence of behaviours in parent-infant interactions.

    The Parent Total (50 items) is the sum of 4 subscales: Sensitivity to Cues (11 items), Response to Distress (11 items), Social-Emotional Growth Fostering (11 items), and Cognitive Growth Fostering (17 items). Higher scores on all subscales and higher total scores reflect more optimal parent-infant interactions.

    Possible ranges of scores are as follows: Parent Total (0 - 50), Sensitivity to Cues (0 - 11), Response to Distress (0 - 11), Social-Emotional Growth Fostering (0 - 11), and Cognitive Growth Fostering (0 - 17)



Secondary Outcome Measures:
  • Parenting Stress - Parenting Stress Index - Third Edition (PSI-3) [ Time Frame: When the infant was 8 months old, adjusting for prematurity ]

    A 120-item self-report questionnaire of parenting stress with two domains. The Parent Domain (51 items) measures stress related to parental functioning, the Child Domain (50 items) measures child qualities and characteristics that contribute to stress in the parent-child system. The PSI-3 contains an additional Life Stress scale (19 items) which was not used in the study.

    The range of possible scores in the Parent Domain is 50 - 250 and in the Child Domain is 51 - 255. In both domains, higher scores indicate more stress.


  • Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale [ Time Frame: When the infant was 8 months old, adjusting for prematurity ]
    25-item self-report measure composed of 3 subscales: Evaluation (11 items), Centrality (8 items), and Life Change (6 items). Each item is rated on a 9-point scale and subscale scores are obtained by averaging the scores of all items on a subscale; the range for all subscales is therefore 1 - 9. Higher scores reflect having more of the attribute being measured.


Enrollment: 113
Study Start Date: December 2008
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
Standard Dose - Two intervention home visits (at 4 and 6 months of age)
Behavioral: Standard Dose
Two intevention home visits
Experimental: Group B Purple
High Dose - Four intervention home visits (at 4, 5, 6, and 7 months of age)
Behavioral: High Dose
Four intervention home visits
Sham Comparator: Group C Yellow
Comparison Group - One home visit, information only (at 4 months of age)
Behavioral: Comparison Group
One home visit, information only

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 - born between 34 weeks and 0 days and 36 weeks and 6 days gestation, 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
Investigators
Principal Investigator: Karen M Benzies, PhD 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 ( Other Grant/Funding Number: Alberta Centre for Child, Family & Community Research )
Study First Received: January 22, 2010
Results First Received: August 8, 2016
Last Updated: February 27, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 19, 2017