Premature Birth
Conditions
Keywords
father-child relations, paternal behaviour, early intervention, child-rearing
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.
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.
Interventions
Two intevention home visits
Four intervention home visits
One home visit, information only
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent Child Interaction Teaching Scale (PCITS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Parenting Stress - Parenting Stress Index - Third Edition (PSI-3) | 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 | 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. |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited from two Canadian cities between December 2008 and June 2011. There were 1035 fathers that were contacted during birth admission (102 enrolled), from another study (7 enrolled), or from a neonatal database (4 enrolled).
Pre-assignment details
Potential participants were screened and enlisted at the time of the infant's birth. When the infant was 2.5 months old, additional screening was done and verbal consent secured.
Participants by arm
| Arm | Count |
|---|---|
| Group A Teal Two intervention home visits
Standard Dose: Two home visits | 46 |
| Group B Purple Four home visits
High Dose: Four home visits | 23 |
| Group C Yellow Comparison Group (information only)
Comparison Group: One home visit, information only | 42 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Group A Teal | Group B Purple | Group C Yellow | Total |
|---|---|---|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 6.44 | 34.28 years STANDARD_DEVIATION 4.24 | 34.47 years STANDARD_DEVIATION 6.01 | 34.13 years STANDARD_DEVIATION 5.85 |
| Education level Completed college/technical school | 12 participants | 4 participants | 8 participants | 24 participants |
| Education level High school or less | 5 participants | 2 participants | 2 participants | 9 participants |
| Education level Partial university/college/technical school | 5 participants | 4 participants | 9 participants | 18 participants |
| Education level Postgraduate degree | 6 participants | 5 participants | 7 participants | 18 participants |
| Education level University degree | 18 participants | 8 participants | 16 participants | 42 participants |
| Employment Status Caring for family | 0 participants | 1 participants | 0 participants | 1 participants |
| Employment Status Going to school | 0 participants | 0 participants | 0 participants | 0 participants |
| Employment Status Looking for work | 1 participants | 1 participants | 1 participants | 3 participants |
| Employment Status On parental leave | 1 participants | 0 participants | 1 participants | 2 participants |
| Employment Status Other | 0 participants | 0 participants | 1 participants | 1 participants |
| Employment Status Working (Full- or part-time) | 44 participants | 21 participants | 39 participants | 104 participants |
| Household income >=$100,000 | 31 participants | 13 participants | 31 participants | 75 participants |
| Household income <$40,000 | 3 participants | 0 participants | 2 participants | 5 participants |
| Household income $40,000-$59,999 | 3 participants | 2 participants | 3 participants | 8 participants |
| Household income $60,000-$79,999 | 4 participants | 5 participants | 0 participants | 9 participants |
| Household income $80,000-$99,999 | 5 participants | 3 participants | 6 participants | 14 participants |
| Infants gestational age | 250 days STANDARD_DEVIATION 6.27 | 248 days STANDARD_DEVIATION 6.4 | 249 days STANDARD_DEVIATION 6.61 | 249.08 days STANDARD_DEVIATION 6.41 |
| Main Language Spoken at Home Chinese | 1 participants | 0 participants | 0 participants | 1 participants |
| Main Language Spoken at Home English | 43 participants | 22 participants | 40 participants | 105 participants |
| Main Language Spoken at Home Farsi | 1 participants | 0 participants | 0 participants | 1 participants |
| Main Language Spoken at Home French | 0 participants | 0 participants | 1 participants | 1 participants |
| Main Language Spoken at Home Oriya | 0 participants | 1 participants | 0 participants | 1 participants |
| Main Language Spoken at Home Punjabi | 1 participants | 0 participants | 0 participants | 1 participants |
| Main Language Spoken at Home Spanish | 0 participants | 0 participants | 1 participants | 1 participants |
| Marital Status Common law/living with partner/living as married | 9 participants | 3 participants | 7 participants | 19 participants |
| Marital Status Married | 37 participants | 20 participants | 35 participants | 92 participants |
| Parent Child Interaction Teaching Scale (PCITS) Parent Total | 39.72 Scores on a scale STANDARD_DEVIATION 4.41 | 40.70 Scores on a scale STANDARD_DEVIATION 3.89 | 40.26 Scores on a scale STANDARD_DEVIATION 4.13 | 40.13 Scores on a scale STANDARD_DEVIATION 4.18 |
| Parent Child Interaction Teaching Scale (PCITS) Subscale - Cognitive Growth Fostering | 11.63 Scores on a scale STANDARD_DEVIATION 2.2 | 12.13 Scores on a scale STANDARD_DEVIATION 1.91 | 11.52 Scores on a scale STANDARD_DEVIATION 2.65 | 11.69 Scores on a scale STANDARD_DEVIATION 2.32 |
| Parent Child Interaction Teaching Scale (PCITS) Subscale - Response to Distress | 10.15 Scores on a scale STANDARD_DEVIATION 0.99 | 10.22 Scores on a scale STANDARD_DEVIATION 0.8 | 10.17 Scores on a scale STANDARD_DEVIATION 0.76 | 10.17 Scores on a scale STANDARD_DEVIATION 0.86 |
| Parent Child Interaction Teaching Scale (PCITS) Subscale - Sensitivity to Cues | 9.61 Scores on a scale STANDARD_DEVIATION 1.37 | 9.52 Scores on a scale STANDARD_DEVIATION 1.31 | 9.88 Scores on a scale STANDARD_DEVIATION 1.11 | 9.69 Scores on a scale STANDARD_DEVIATION 1.26 |
| Parent Child Interaction Teaching Scale (PCITS) Subscale - Socioemotional Growth Fostering | 8.33 Scores on a scale STANDARD_DEVIATION 1.65 | 8.83 Scores on a scale STANDARD_DEVIATION 1.3 | 8.69 Scores on a scale STANDARD_DEVIATION 1.7 | 8.57 Scores on a scale STANDARD_DEVIATION 1.61 |
| Parenting Stress - Parenting Stress Index - Third Edition (PSI-3) Child Domain | 96.37 Scores on a scale STANDARD_DEVIATION 16.78 | 96.57 Scores on a scale STANDARD_DEVIATION 17 | 96.71 Scores on a scale STANDARD_DEVIATION 15.9 | 96.54 Scores on a scale STANDARD_DEVIATION 16.35 |
| Parenting Stress - Parenting Stress Index - Third Edition (PSI-3) Parent Domain | 107.46 Scores on a scale STANDARD_DEVIATION 15.73 | 107.00 Scores on a scale STANDARD_DEVIATION 19.73 | 108.60 Scores on a scale STANDARD_DEVIATION 19.56 | 107.79 Scores on a scale STANDARD_DEVIATION 17.95 |
| Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale Centrality | 6.99 Scores on a scale STANDARD_DEVIATION 0.81 | 6.47 Scores on a scale STANDARD_DEVIATION 0.81 | 6.75 Scores on a scale STANDARD_DEVIATION 1.04 | 6.79 Scores on a scale STANDARD_DEVIATION 0.92 |
| Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale Evaluation | 7.58 Scores on a scale STANDARD_DEVIATION 0.64 | 7.58 Scores on a scale STANDARD_DEVIATION 0.72 | 7.52 Scores on a scale STANDARD_DEVIATION 0.8 | 7.56 Scores on a scale STANDARD_DEVIATION 0.72 |
| Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale Life Change | 6.77 Scores on a scale STANDARD_DEVIATION 1.02 | 6.03 Scores on a scale STANDARD_DEVIATION 1.5 | 6.28 Scores on a scale STANDARD_DEVIATION 1.39 | 6.43 Scores on a scale STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized Arab/West Asian | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black | 2 participants | 0 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Chinese | 1 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Did Not Answer | 1 participants | 1 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized European | 30 participants | 19 participants | 35 participants | 84 participants |
| Race/Ethnicity, Customized Filipino | 2 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Latin American | 1 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized More than one Option Selected | 3 participants | 0 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized North American First Nations | 2 participants | 1 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized South Asian | 2 participants | 2 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 46 Participants | 23 Participants | 42 Participants | 111 Participants |
| Sex of the Infant Females | 20 infants | 11 infants | 17 infants | 48 infants |
| Sex of the Infant Males | 26 infants | 12 infants | 25 infants | 63 infants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 23 | 0 / 42 |
| serious Total, serious adverse events | 0 / 46 | 0 / 23 | 0 / 42 |
Outcome results
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)
Time frame: When the infant was 8 months old, adjusting for prematurity
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A Teal | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Cognitive Growth Fostering | 12.91 Scores on a scale | Standard Deviation 1.98 |
| Group A Teal | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Socioemotional Growth Fostering | 8.07 Scores on a scale | Standard Deviation 1.72 |
| Group A Teal | Parent Child Interaction Teaching Scale (PCITS) | Parent Total | 40.00 Scores on a scale | Standard Deviation 3.77 |
| Group A Teal | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Sensitivity to Cues | 9.26 Scores on a scale | Standard Deviation 0.98 |
| Group A Teal | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Response to Distress | 9.76 Scores on a scale | Standard Deviation 0.87 |
| Group B Purple | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Socioemotional Growth Fostering | 9.00 Scores on a scale | Standard Deviation 1.62 |
| Group B Purple | Parent Child Interaction Teaching Scale (PCITS) | Parent Total | 41.61 Scores on a scale | Standard Deviation 4.03 |
| Group B Purple | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Sensitivity to Cues | 9.17 Scores on a scale | Standard Deviation 0.98 |
| Group B Purple | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Cognitive Growth Fostering | 13.52 Scores on a scale | Standard Deviation 2.33 |
| Group B Purple | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Response to Distress | 9.91 Scores on a scale | Standard Deviation 0.95 |
| Group C Yellow | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Response to Distress | 9.74 Scores on a scale | Standard Deviation 0.89 |
| Group C Yellow | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Cognitive Growth Fostering | 12.10 Scores on a scale | Standard Deviation 2.37 |
| Group C Yellow | Parent Child Interaction Teaching Scale (PCITS) | Parent Total | 38.83 Scores on a scale | Standard Deviation 4.33 |
| Group C Yellow | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Socioemotional Growth Fostering | 7.93 Scores on a scale | Standard Deviation 1.44 |
| Group C Yellow | Parent Child Interaction Teaching Scale (PCITS) | Subscale - Sensitivity to Cues | 9.07 Scores on a scale | Standard Deviation 1.07 |
Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)
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.
Time frame: When the infant was 8 months old, adjusting for prematurity
Population: Group A Teal n = 44 due to missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A Teal | Parenting Stress - Parenting Stress Index - Third Edition (PSI-3) | Child Domain | 93.52 Scores on a scale | Standard Deviation 14.83 |
| Group A Teal | Parenting Stress - Parenting Stress Index - Third Edition (PSI-3) | Parent Domain | 106.48 Scores on a scale | Standard Deviation 15.51 |
| Group B Purple | Parenting Stress - Parenting Stress Index - Third Edition (PSI-3) | Child Domain | 89.96 Scores on a scale | Standard Deviation 16.65 |
| Group B Purple | Parenting Stress - Parenting Stress Index - Third Edition (PSI-3) | Parent Domain | 103.52 Scores on a scale | Standard Deviation 18.37 |
| Group C Yellow | Parenting Stress - Parenting Stress Index - Third Edition (PSI-3) | Child Domain | 93.26 Scores on a scale | Standard Deviation 13.43 |
| Group C Yellow | Parenting Stress - Parenting Stress Index - Third Edition (PSI-3) | Parent Domain | 107.12 Scores on a scale | Standard Deviation 20.46 |
Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale
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.
Time frame: When the infant was 8 months old, adjusting for prematurity
Population: Goup A Teal n = 45 due to missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A Teal | Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale | Centrality | 6.85 Scores on a scale | Standard Deviation 0.84 |
| Group A Teal | Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale | Evaluation | 7.77 Scores on a scale | Standard Deviation 0.54 |
| Group A Teal | Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale | Life Change | 6.74 Scores on a scale | Standard Deviation 1.12 |
| Group B Purple | Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale | Centrality | 6.48 Scores on a scale | Standard Deviation 1.04 |
| Group B Purple | Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale | Evaluation | 7.97 Scores on a scale | Standard Deviation 0.48 |
| Group B Purple | Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale | Life Change | 5.93 Scores on a scale | Standard Deviation 1.41 |
| Group C Yellow | Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale | Evaluation | 7.85 Scores on a scale | Standard Deviation 0.52 |
| Group C Yellow | Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale | Life Change | 6.58 Scores on a scale | Standard Deviation 1.14 |
| Group C Yellow | Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale | Centrality | 6.58 Scores on a scale | Standard Deviation 0.79 |