Trial Outcomes & Findings for Fathers and Late Preterm Babies Study (NCT NCT01056653)
NCT ID: NCT01056653
Last Updated: 2017-03-29
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
When the infant was 8 months old, adjusting for prematurity
Results posted on
2017-03-29
Participant Flow
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).
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.
Participant milestones
| Measure |
Group A Teal
Two intervention home visits
Standard Dose: Two home visits (at 4 and 6 months of age)
|
Group B Purple
Four home visits
High Dose: Four home visits (at 4, 5, 6, and 7 months of age)
|
Group C Yellow
Comparison Group (information only)
Comparison Group: One home visit, information only (at 4 months of age)
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
23
|
44
|
|
Overall Study
COMPLETED
|
46
|
23
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Group A Teal
Two intervention home visits
Standard Dose: Two home visits (at 4 and 6 months of age)
|
Group B Purple
Four home visits
High Dose: Four home visits (at 4, 5, 6, and 7 months of age)
|
Group C Yellow
Comparison Group (information only)
Comparison Group: One home visit, information only (at 4 months of age)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
Baseline Characteristics
Fathers and Late Preterm Babies Study
Baseline characteristics by cohort
| Measure |
Group A Teal
n=46 Participants
Two intervention home visits
Standard Dose: Two home visits
|
Group B Purple
n=23 Participants
Four home visits
High Dose: Four home visits
|
Group C Yellow
n=42 Participants
Comparison Group (information only)
Comparison Group: One home visit, information only
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 6.44 • n=5 Participants
|
34.28 years
STANDARD_DEVIATION 4.24 • n=7 Participants
|
34.47 years
STANDARD_DEVIATION 6.01 • n=5 Participants
|
34.13 years
STANDARD_DEVIATION 5.85 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
European
|
30 participants
n=5 Participants
|
19 participants
n=7 Participants
|
35 participants
n=5 Participants
|
84 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Filipino
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Arab/West Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
North American First Nations
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one Option Selected
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Did Not Answer
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Sex of the Infant
Males
|
26 infants
n=5 Participants
|
12 infants
n=7 Participants
|
25 infants
n=5 Participants
|
63 infants
n=4 Participants
|
|
Sex of the Infant
Females
|
20 infants
n=5 Participants
|
11 infants
n=7 Participants
|
17 infants
n=5 Participants
|
48 infants
n=4 Participants
|
|
Infants gestational age
|
250 days
STANDARD_DEVIATION 6.27 • n=5 Participants
|
248 days
STANDARD_DEVIATION 6.40 • n=7 Participants
|
249 days
STANDARD_DEVIATION 6.61 • n=5 Participants
|
249.08 days
STANDARD_DEVIATION 6.41 • n=4 Participants
|
|
Education level
High school or less
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Education level
Partial university/college/technical school
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Education level
Completed college/technical school
|
12 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Education level
University degree
|
18 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Education level
Postgraduate degree
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Household income
<$40,000
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Household income
$40,000-$59,999
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Household income
$60,000-$79,999
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Household income
$80,000-$99,999
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Household income
>=$100,000
|
31 participants
n=5 Participants
|
13 participants
n=7 Participants
|
31 participants
n=5 Participants
|
75 participants
n=4 Participants
|
|
Employment Status
Working (Full- or part-time)
|
44 participants
n=5 Participants
|
21 participants
n=7 Participants
|
39 participants
n=5 Participants
|
104 participants
n=4 Participants
|
|
Employment Status
On parental leave
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Employment Status
Looking for work
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Employment Status
Going to school
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Employment Status
Caring for family
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Employment Status
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Marital Status
Married
|
37 participants
n=5 Participants
|
20 participants
n=7 Participants
|
35 participants
n=5 Participants
|
92 participants
n=4 Participants
|
|
Marital Status
Common law/living with partner/living as married
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Main Language Spoken at Home
English
|
43 participants
n=5 Participants
|
22 participants
n=7 Participants
|
40 participants
n=5 Participants
|
105 participants
n=4 Participants
|
|
Main Language Spoken at Home
Chinese
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Main Language Spoken at Home
Farsi
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Main Language Spoken at Home
French
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Main Language Spoken at Home
Oriya
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Main Language Spoken at Home
Punjabi
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Main Language Spoken at Home
Spanish
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Parent Child Interaction Teaching Scale (PCITS)
Parent Total
|
39.72 Scores on a scale
STANDARD_DEVIATION 4.41 • n=5 Participants
|
40.70 Scores on a scale
STANDARD_DEVIATION 3.89 • n=7 Participants
|
40.26 Scores on a scale
STANDARD_DEVIATION 4.13 • n=5 Participants
|
40.13 Scores on a scale
STANDARD_DEVIATION 4.18 • n=4 Participants
|
|
Parent Child Interaction Teaching Scale (PCITS)
Subscale - Sensitivity to Cues
|
9.61 Scores on a scale
STANDARD_DEVIATION 1.37 • n=5 Participants
|
9.52 Scores on a scale
STANDARD_DEVIATION 1.31 • n=7 Participants
|
9.88 Scores on a scale
STANDARD_DEVIATION 1.11 • n=5 Participants
|
9.69 Scores on a scale
STANDARD_DEVIATION 1.26 • n=4 Participants
|
|
Parent Child Interaction Teaching Scale (PCITS)
Subscale - Socioemotional Growth Fostering
|
8.33 Scores on a scale
STANDARD_DEVIATION 1.65 • n=5 Participants
|
8.83 Scores on a scale
STANDARD_DEVIATION 1.30 • n=7 Participants
|
8.69 Scores on a scale
STANDARD_DEVIATION 1.70 • n=5 Participants
|
8.57 Scores on a scale
STANDARD_DEVIATION 1.61 • n=4 Participants
|
|
Parent Child Interaction Teaching Scale (PCITS)
Subscale - Cognitive Growth Fostering
|
11.63 Scores on a scale
STANDARD_DEVIATION 2.20 • n=5 Participants
|
12.13 Scores on a scale
STANDARD_DEVIATION 1.91 • n=7 Participants
|
11.52 Scores on a scale
STANDARD_DEVIATION 2.65 • n=5 Participants
|
11.69 Scores on a scale
STANDARD_DEVIATION 2.32 • n=4 Participants
|
|
Parent Child Interaction Teaching Scale (PCITS)
Subscale - Response to Distress
|
10.15 Scores on a scale
STANDARD_DEVIATION 0.99 • n=5 Participants
|
10.22 Scores on a scale
STANDARD_DEVIATION 0.80 • n=7 Participants
|
10.17 Scores on a scale
STANDARD_DEVIATION 0.76 • n=5 Participants
|
10.17 Scores on a scale
STANDARD_DEVIATION 0.86 • n=4 Participants
|
|
Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)
Child Domain
|
96.37 Scores on a scale
STANDARD_DEVIATION 16.78 • n=5 Participants
|
96.57 Scores on a scale
STANDARD_DEVIATION 17.00 • n=7 Participants
|
96.71 Scores on a scale
STANDARD_DEVIATION 15.90 • n=5 Participants
|
96.54 Scores on a scale
STANDARD_DEVIATION 16.35 • n=4 Participants
|
|
Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)
Parent Domain
|
107.46 Scores on a scale
STANDARD_DEVIATION 15.73 • n=5 Participants
|
107.00 Scores on a scale
STANDARD_DEVIATION 19.73 • n=7 Participants
|
108.60 Scores on a scale
STANDARD_DEVIATION 19.56 • n=5 Participants
|
107.79 Scores on a scale
STANDARD_DEVIATION 17.95 • n=4 Participants
|
|
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 • n=5 Participants
|
7.58 Scores on a scale
STANDARD_DEVIATION 0.72 • n=7 Participants
|
7.52 Scores on a scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
7.56 Scores on a scale
STANDARD_DEVIATION 0.72 • n=4 Participants
|
|
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 • n=5 Participants
|
6.47 Scores on a scale
STANDARD_DEVIATION 0.81 • n=7 Participants
|
6.75 Scores on a scale
STANDARD_DEVIATION 1.04 • n=5 Participants
|
6.79 Scores on a scale
STANDARD_DEVIATION 0.92 • n=4 Participants
|
|
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 • n=5 Participants
|
6.03 Scores on a scale
STANDARD_DEVIATION 1.50 • n=7 Participants
|
6.28 Scores on a scale
STANDARD_DEVIATION 1.39 • n=5 Participants
|
6.43 Scores on a scale
STANDARD_DEVIATION 1.30 • n=4 Participants
|
PRIMARY outcome
Timeframe: When the infant was 8 months old, adjusting for prematurityAssesses 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)
Outcome measures
| Measure |
Group A Teal
n=46 Participants
Two intervention home visits
Standard Dose: Two home visits
|
Group B Purple
n=23 Participants
Four intervention home visits
High Dose: Four home visits
|
Group C Yellow
n=42 Participants
Comparison Group (information only)
Comparison Group: One home visit, information only
|
|---|---|---|---|
|
Parent Child Interaction Teaching Scale (PCITS)
Parent Total
|
40.00 Scores on a scale
Standard Deviation 3.77
|
41.61 Scores on a scale
Standard Deviation 4.03
|
38.83 Scores on a scale
Standard Deviation 4.33
|
|
Parent Child Interaction Teaching Scale (PCITS)
Subscale - Sensitivity to Cues
|
9.26 Scores on a scale
Standard Deviation 0.98
|
9.17 Scores on a scale
Standard Deviation 0.98
|
9.07 Scores on a scale
Standard Deviation 1.07
|
|
Parent Child Interaction Teaching Scale (PCITS)
Subscale - Socioemotional Growth Fostering
|
8.07 Scores on a scale
Standard Deviation 1.72
|
9.00 Scores on a scale
Standard Deviation 1.62
|
7.93 Scores on a scale
Standard Deviation 1.44
|
|
Parent Child Interaction Teaching Scale (PCITS)
Subscale - Cognitive Growth Fostering
|
12.91 Scores on a scale
Standard Deviation 1.98
|
13.52 Scores on a scale
Standard Deviation 2.33
|
12.10 Scores on a scale
Standard Deviation 2.37
|
|
Parent Child Interaction Teaching Scale (PCITS)
Subscale - Response to Distress
|
9.76 Scores on a scale
Standard Deviation 0.87
|
9.91 Scores on a scale
Standard Deviation 0.95
|
9.74 Scores on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: When the infant was 8 months old, adjusting for prematurityPopulation: Group A Teal n = 44 due to missing data
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.
Outcome measures
| Measure |
Group A Teal
n=44 Participants
Two intervention home visits
Standard Dose: Two home visits
|
Group B Purple
n=23 Participants
Four intervention home visits
High Dose: Four home visits
|
Group C Yellow
n=42 Participants
Comparison Group (information only)
Comparison Group: One home visit, information only
|
|---|---|---|---|
|
Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)
Child Domain
|
93.52 Scores on a scale
Standard Deviation 14.83
|
89.96 Scores on a scale
Standard Deviation 16.65
|
93.26 Scores on a scale
Standard Deviation 13.43
|
|
Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)
Parent Domain
|
106.48 Scores on a scale
Standard Deviation 15.51
|
103.52 Scores on a scale
Standard Deviation 18.37
|
107.12 Scores on a scale
Standard Deviation 20.46
|
SECONDARY outcome
Timeframe: When the infant was 8 months old, adjusting for prematurityPopulation: Goup A Teal n = 45 due to missing data
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.
Outcome measures
| Measure |
Group A Teal
n=45 Participants
Two intervention home visits
Standard Dose: Two home visits
|
Group B Purple
n=23 Participants
Four intervention home visits
High Dose: Four home visits
|
Group C Yellow
n=42 Participants
Comparison Group (information only)
Comparison Group: One home visit, information only
|
|---|---|---|---|
|
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
|
7.97 Scores on a scale
Standard Deviation 0.48
|
7.85 Scores on a scale
Standard Deviation 0.52
|
|
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
|
6.48 Scores on a scale
Standard Deviation 1.04
|
6.58 Scores on a scale
Standard Deviation 0.79
|
|
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
|
5.93 Scores on a scale
Standard Deviation 1.41
|
6.58 Scores on a scale
Standard Deviation 1.14
|
Adverse Events
Group A Teal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B Purple
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C Yellow
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Karen Benzies
University of Calgary, Faculty of Nursing
Phone: 403-220-2294
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place