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
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth||Behavioral: Standard Dose Behavioral: High Dose Behavioral: Comparison Group||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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)
- 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.
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
|University of Calgary|
|Calgary, Alberta, Canada, T2N 1N4|
|Principal Investigator:||Karen M Benzies, PhD||University of Calgary|