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Fathers and Late Preterm Babies Study (FLPTB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Premature Birth
Interventions Behavioral: Standard Dose
Behavioral: High Dose
Behavioral: Comparison Group
Enrollment 113
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.
Arm/Group Title Group A Teal Group B Purple Group C Yellow
Hide Arm/Group Description

Two intervention home visits

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

Four home visits

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

Comparison Group (information only)

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

Period Title: Overall Study
Started 46 23 44
Completed 46 23 42 [1]
Not Completed 0 0 2
Reason Not Completed
Lost to Follow-up             0             0             2
[1]
2 were lost to follow-up because one mother left the country and one father was too busy.
Arm/Group Title Group A Teal Group B Purple Group C Yellow Total
Hide Arm/Group Description

Two intervention home visits

Standard Dose: Two home visits

Four home visits

High Dose: Four home visits

Comparison Group (information only)

Comparison Group: One home visit, information only

Total of all reporting groups
Overall Number of Baseline Participants 46 23 42 111
Hide Baseline Analysis Population Description
Sociodemographic and health data were collected with the first home visit.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 23 participants 42 participants 111 participants
33.7  (6.44) 34.28  (4.24) 34.47  (6.01) 34.13  (5.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 23 participants 42 participants 111 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
46
 100.0%
23
 100.0%
42
 100.0%
111
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 23 participants 42 participants 111 participants
European 30 19 35 84
Filipino 2 0 0 2
Chinese 1 0 1 2
South Asian 2 2 2 6
Arab/West Asian 1 0 0 1
Black 2 0 1 3
North American First Nations 2 1 1 4
Latin American 1 0 1 2
Other 1 0 1 2
More than one Option Selected 3 0 0 3
Did Not Answer 1 1 0 2
Sex of the Infant  
Measure Type: Number
Unit of measure:  Infants
Number Analyzed 46 participants 23 participants 42 participants 111 participants
Males 26 12 25 63
Females 20 11 17 48
Infants gestational age  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 46 participants 23 participants 42 participants 111 participants
250  (6.27) 248  (6.40) 249  (6.61) 249.08  (6.41)
Education level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 23 participants 42 participants 111 participants
High school or less 5 2 2 9
Partial university/college/technical school 5 4 9 18
Completed college/technical school 12 4 8 24
University degree 18 8 16 42
Postgraduate degree 6 5 7 18
Household income  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 23 participants 42 participants 111 participants
<$40,000 3 0 2 5
$40,000-$59,999 3 2 3 8
$60,000-$79,999 4 5 0 9
$80,000-$99,999 5 3 6 14
>=$100,000 31 13 31 75
Employment Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 23 participants 42 participants 111 participants
Working (Full- or part-time) 44 21 39 104
On parental leave 1 0 1 2
Looking for work 1 1 1 3
Going to school 0 0 0 0
Caring for family 0 1 0 1
Other 0 0 1 1
Marital Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 23 participants 42 participants 111 participants
Married 37 20 35 92
Common law/living with partner/living as married 9 3 7 19
[1]
Measure Description: Participants had to be married or living together to be able to participate in the study.
Main Language Spoken at Home   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 23 participants 42 participants 111 participants
English 43 22 40 105
Chinese 1 0 0 1
Farsi 1 0 0 1
French 0 0 1 1
Oriya 0 1 0 1
Punjabi 1 0 0 1
Spanish 0 0 1 1
[1]
Measure Description: Speaking mainly English at home was one of the eligibility criteria. Participants who answered anything but English in the 4 month questionnaire would have indicated at recruitment when their baby was born that they speak mainly English at home.
Parent Child Interaction Teaching Scale (PCITS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 46 participants 23 participants 42 participants 111 participants
Parent Total 39.72  (4.41) 40.70  (3.89) 40.26  (4.13) 40.13  (4.18)
Subscale - Sensitivity to Cues 9.61  (1.37) 9.52  (1.31) 9.88  (1.11) 9.69  (1.26)
Subscale - Socioemotional Growth Fostering 8.33  (1.65) 8.83  (1.30) 8.69  (1.70) 8.57  (1.61)
Subscale - Cognitive Growth Fostering 11.63  (2.20) 12.13  (1.91) 11.52  (2.65) 11.69  (2.32)
Subscale - Response to Distress 10.15  (0.99) 10.22  (0.80) 10.17  (0.76) 10.17  (0.86)
[1]
Measure Description:

Collected when the infant was 4 months old. 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.

Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 46 participants 23 participants 42 participants 111 participants
Child Domain 96.37  (16.78) 96.57  (17.00) 96.71  (15.90) 96.54  (16.35)
Parent Domain 107.46  (15.73) 107.00  (19.73) 108.60  (19.56) 107.79  (17.95)
[1]
Measure Description:

Collected when the infant was 4 months old.

A 120-item self-report questionnaire with two domains of parent (51 items) and child (50 items) stress. Higher scores indicate more stress.

Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 46 participants 23 participants 42 participants 111 participants
Evaluation 7.58  (0.64) 7.58  (0.72) 7.52  (0.80) 7.56  (0.72)
Centrality 6.99  (0.81) 6.47  (0.81) 6.75  (1.04) 6.79  (0.92)
Life Change 6.77  (1.02) 6.03  (1.50) 6.28  (1.39) 6.43  (1.30)
[1]
Measure Description:

Collected when the infant was 4 months old.

A 25-item self-report measure that looks at the perceptions the parents have of caring for an infant. There are 3 subscales: Evaluation, Centrality, and Life Change. Each item is on the 9-point scale.

Higher scores reflect having more of the attribute.

1.Primary Outcome
Title Parent Child Interaction Teaching Scale (PCITS)
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Teal Group B Purple Group C Yellow
Hide Arm/Group Description:

Two intervention home visits

Standard Dose: Two home visits

Four intervention home visits

High Dose: Four home visits

Comparison Group (information only)

Comparison Group: One home visit, information only

Overall Number of Participants Analyzed 46 23 42
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Parent Total 40.00  (3.77) 41.61  (4.03) 38.83  (4.33)
Subscale - Sensitivity to Cues 9.26  (0.98) 9.17  (0.98) 9.07  (1.07)
Subscale - Socioemotional Growth Fostering 8.07  (1.72) 9.00  (1.62) 7.93  (1.44)
Subscale - Cognitive Growth Fostering 12.91  (1.98) 13.52  (2.33) 12.10  (2.37)
Subscale - Response to Distress 9.76  (0.87) 9.91  (0.95) 9.74  (0.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group B Purple, Group C Yellow
Comments ANCOVA - Group Comparison of Parent Total Score on PCITS at 8 months, controlling for scores at baseline (4 months). Group entered as as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.03
Comments [Not Specified]
Method ANCOVA
Comments F(2,107)=3.48, partial n2=0.061, observed power=0.639
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B Purple, Group C Yellow
Comments Pairwise Group Comparison based on estimated marginal means - Parent Total Scores
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Bonferroni adjustments for multiple comparisons used
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group C Yellow
Comments Pairwise Group Comparison based on estimated marginal means - Parent Total Scores
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.534
Comments Bonferroni adjustment for multiple comparisons used
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group B Purple, Group C Yellow
Comments ANCOVA - Group Comparison of Cognitive Growth Fostering Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method ANCOVA
Comments F(2,107)=3.145, partial n2=0.056, observed power=0.593.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group B Purple, Group C Yellow
Comments Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments Bonferroni adjustments for multiple comparisons used
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group C Yellow
Comments Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.267
Comments Bonferroni adjustments for multiple comparisons used
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group B Purple, Group C Yellow
Comments ANCOVA - Group Comparison of Socio-Emotional Growth Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method ANCOVA
Comments F(2,107)=3.440, partial n2=0.060, observed power=0.634
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Group B Purple, Group C Yellow
Comments Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments Bonferroni adjustments for multiple comparisons used
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group C Yellow
Comments Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments Bonferroni adjustments for multiple comparisons used
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group B Purple, Group C Yellow
Comments ANCOVA - Group Comparison of Sensitivity to Cues Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.665
Comments [Not Specified]
Method ANCOVA
Comments F(2,107)=0.409
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group B Purple, Group C Yellow
Comments ANCOVA - Group Comparison of Response to Distress Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.732
Comments [Not Specified]
Method ANCOVA
Comments F(2,107)=0.313
2.Secondary Outcome
Title Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Group A Teal n = 44 due to missing data
Arm/Group Title Group A Teal Group B Purple Group C Yellow
Hide Arm/Group Description:

Two intervention home visits

Standard Dose: Two home visits

Four intervention home visits

High Dose: Four home visits

Comparison Group (information only)

Comparison Group: One home visit, information only

Overall Number of Participants Analyzed 44 23 42
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Child Domain 93.52  (14.83) 89.96  (16.65) 93.26  (13.43)
Parent Domain 106.48  (15.51) 103.52  (18.37) 107.12  (20.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group B Purple, Group C Yellow
Comments ANCOVA - Group Comparison of Parent Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method ANCOVA
Comments F(2,107)=0.49
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group B Purple, Group C Yellow
Comments ANCOVA - Group Comparison of Child Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method ANCOVA
Comments F(2,107)=0.96
3.Secondary Outcome
Title Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Goup A Teal n = 45 due to missing data
Arm/Group Title Group A Teal Group B Purple Group C Yellow
Hide Arm/Group Description:

Two intervention home visits

Standard Dose: Two home visits

Four home visits

High Dose: Four home visits

Comparison Group (information only)

Comparison Group: One home visit, information only

Overall Number of Participants Analyzed 45 23 42
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Evaluation 7.77  (0.54) 7.97  (0.48) 7.85  (0.52)
Centrality 6.85  (0.84) 6.48  (1.04) 6.58  (0.79)
Life Change 6.74  (1.12) 5.93  (1.41) 6.58  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group B Purple, Group C Yellow
Comments ANCOVA - Group Comparison of WPL-R scores - Evaluation Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method ANCOVA
Comments F(2,106)=2.24.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group B Purple, Group C Yellow
Comments ANCOVA - Group Comparison of WPL-R scores - Centrality Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.686
Comments [Not Specified]
Method ANCOVA
Comments F(2,106)=0.379
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A Teal, Group B Purple, Group C Yellow
Comments ANCOVA - Group Comparison of WPL-R scores - Life Change Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.121
Comments [Not Specified]
Method ANCOVA
Comments F(2,106)=2.158
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Teal Group B Purple Group C Yellow
Hide Arm/Group Description

Two intervention home visits

Standard Dose: Two home visits

Four home visits

High Dose: Four home visits

Comparison Group (information only)

Comparison Group: One home visit, information only

All-Cause Mortality
Group A Teal Group B Purple Group C Yellow
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group A Teal Group B Purple Group C Yellow
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/23 (0.00%)   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Teal Group B Purple Group C Yellow
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/23 (0.00%)   0/42 (0.00%) 

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

Limited inter-rater reliability.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Karen Benzies
Organization: University of Calgary, Faculty of Nursing
Phone: 403-220-2294
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, 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 )
First Submitted: January 22, 2010
First Posted: January 26, 2010
Results First Submitted: August 8, 2016
Results First Posted: February 23, 2017
Last Update Posted: March 29, 2017