Fathers and Late Preterm Babies Study (FLPTB)

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ClinicalTrials.gov Identifier: NCT01056653

Recruitment Status : Completed

First Posted : January 26, 2010

Results First Posted : February 23, 2017

Last Update Posted : March 29, 2017

Sponsor:

Information provided by (Responsible Party):

Karen Benzies, University of Calgary

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Premature Birth	Behavioral: Standard Dose Behavioral: High Dose Behavioral: Comparison Group	Not Applicable

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Detailed Description:

Background: Preterm birth (PTB) is associated with 75% of morbidity in neonates. Although mortality and morbidity is higher for children with early PTB (< 32 weeks' gestation), late PTB (between 34 to 36 weeks gestation) is more common and creates a serious impact on public health. Indeed, late PTBs constitute 74% of all PTBs, and even modest increases in the rate of late PTB have dramatic effects on health care costs. PTB rates are rising across Canada and in Alberta at an even faster rate: between 1996 and 2005, the rate of PTB in Alberta increased by 23%. Late PTBs accounted for the majority of this increase. While it is clear that early PTB and being small for gestational age (GA) are risk factors for later developmental challenges even into adulthood, the risks and the negative effects of late PTB on child development are emerging. In spite of evidence that heavier weight (and usually older gestation) infants benefit more from early interventions than their lighter weight counterparts, late preterm infants are ineligible for early intervention programs unless they have other health problems. Most programs are designed for mothers, yet fathers contribute to their child's development by providing interactions that are more vigorous, stimulating, and state-disruptive than mothers. Given their increased risk for delays, it is important that both mothers and fathers of late preterm infants are skilled in parent-child interactions to support development. A new intervention for fathers using positive individualized feedback on parent-child interactions has shown promise in improving interactions with healthy infants. However, it is unknown whether this intervention will be effective for fathers of late preterm infants. The purpose of this study is to test an educational intervention for first-time fathers of late preterm (34 to 36 weeks gestation) infants.

Hypothesis: Compared to a comparison group, first-time fathers of late preterm infants who receive an educational intervention will have more positive father-infant interactions when the infant is 8 months old (adjusted age to account for prematurity) as measured during structured play using the Parent Child Interaction Teaching Scale (PCITS) (also known as the Nursing Child Assessment Teaching Scale [NCATS]) scored by raters who are blind to group assignment.

Secondary Research Question: What is the effect of the intervention on fathers' perceptions of parenting stress as measured by the Parenting Stress Index (PSI) at 4 and 8 months adjusted age? Method: In this pilot randomized controlled trial, data will be collected from 148 English speaking, first time fathers of healthy, late preterm, singleton infants. Fathers in the intervention group will receive two home visits when their infant is 4 and 6 months old (adjusted age) and one web-based booster session. Fathers in the comparison group will receive a home visit and discuss a list of age appropriate toys. For all fathers, baseline interactions and parenting stress will be measured at 4 months with outcomes at 8 months.

Measures: The PCITS is an observational measure used to measure changes in father-child interaction after intervention and includes a Parent Domain score composed of sensitivity to cues, response to distress, cognitive growth fostering, and socio-emotional growth fostering. The PSI is a self-report instrument that provides a Parent Domain score reflecting a parent's experience of stress as a parent. The Child Domain score reflects the parental perceptions of the child's temperament and behaviour. All measures have established reliability and validity and inter-rater reliability will be assessed.

Analyses: The socio-demographic and baseline variables will be compared between study groups using descriptive statistics (mean or median when appropriate, standard deviation or interquartile range when appropriate, and proportions). Correlations will be used to determine relationship between the dependent variable (interaction) and any known confounders that may need to be used as covariates. To test our primary hypothesis that differences will exist between groups on father-infant interaction a linear model adjusting for covariates will be used. The same approach will be used to test overall treatment effect on parenting stress in the Parent and Child Domains. We will include subgroup analyses to test for interaction effects between baseline variables and group, and between fathers who did and did not use the web-based booster.

Significance: The results will help in the design of educational interventions to mitigate risks, and optimize developmental outcomes for late preterm infants through enhancing fathers' interactions with their children, and complementing the effects of mothers' contributions to their children's development.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	113 participants
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
Study Start Date :	December 2008
Actual Primary Completion Date :	February 2012
Actual Study Completion Date :	January 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056653

Locations

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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4

Sponsors and Collaborators

University of Calgary

Investigators

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Principal Investigator:	Karen M Benzies, PhD	University of Calgary

More Information

Publications:

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.

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.

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Responsible Party:	Karen Benzies, Professor, University of Calgary
ClinicalTrials.gov Identifier:	NCT01056653
Other Study ID Numbers:	E-21846 ACCFCR Grant # 0802INV-Benzies ( Other Grant/Funding Number: Alberta Centre for Child, Family & Community Research )
First Posted:	January 26, 2010 Key Record Dates
Results First Posted:	February 23, 2017
Last Update Posted:	March 29, 2017
Last Verified:	February 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:

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Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications

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