Fathers and Late Preterm Babies Study

NCT01056653 | Completed Results

• 2 other identifiers: E-21846ACCFCR Grant # 0802INV-Benzies
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Premature Birth

Keywords

father-child relations; paternal behaviour; early intervention; child-rearing

Outcome Measures

Primary Outcomes (1)

• Parent Child Interaction Teaching Scale (PCITS)

  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)

  When the infant was 8 months old, adjusting for prematurity

Secondary Outcomes (2)

• Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)

  When the infant was 8 months old, adjusting for prematurity

• Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale

  When the infant was 8 months old, adjusting for prematurity

Study Arms (3)

Group A Teal

EXPERIMENTAL

Standard Dose - Two intervention home visits (at 4 and 6 months of age)

Behavioral: Standard Dose

Group B Purple

EXPERIMENTAL

High Dose - Four intervention home visits (at 4, 5, 6, and 7 months of age)

Behavioral: High Dose

Group C Yellow

SHAM COMPARATOR

Comparison Group - One home visit, information only (at 4 months of age)

Behavioral: Comparison Group

Interventions

Standard Dose BEHAVIORAL

Two intevention home visits

Group A Teal

High Dose BEHAVIORAL

Four intervention home visits

Group B Purple

Comparison Group BEHAVIORAL

One home visit, information only

Group C Yellow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (2)

• Benzies K, Magill-Evans J, Harrison MJ, MacPhail S, Kimak C. Strengthening new fathers' skills in interaction with their 5-month-old infants: who benefits from a brief intervention? Public Health Nurs. 2008 Sep-Oct;25(5):431-9. doi: 10.1111/j.1525-1446.2008.00727.x.

  PMID: 18816360 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

Challenges recruiting first-time fathers of late preterm infants; recruiting challenges led to a smaller sample than planned. Limited inter-rater reliability.

Results Point of Contact

• Title: Dr. Karen Benzies
• Organization: University of Calgary, Faculty of Nursing

benzies@ucalgary.ca

403-220-2294

Study Officials

• Karen M Benzies, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 26, 2010
• Study Start: December 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: January 1, 2013
• Last Updated: March 29, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)