A Cluster Randomized Controlled Trial of FICare at 18 Months
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|ClinicalTrials.gov Identifier: NCT03337659|
Recruitment Status : Enrolling by invitation
First Posted : November 9, 2017
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth||Other: Family Integrated Care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||422 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Child Developmental Health, Maternal Psychosocial Distress, and Health System Costs at 18 Months Corrected Age: Effectiveness of a Cluster Randomized Controlled Trial of Family Integrated Care in Level II NICUs|
|Actual Study Start Date :||September 27, 2017|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: FICare Intervention Group
Study participants received Family Integrated Care (intervention) while their infant(s) was/were admitted to a Level II NICU.
Other: Family Integrated Care
FICare is a dynamic psycho-educational intervention. The goal of FICare is a change in culture and practice that permits, encourages and supports parents in their parenting role while their infant is receiving health care in a Level II NICU. Underpinned by adult learning and change theories, FICare empowers parents to build their knowledge, skill and confidence so that the family is well-prepared to care for their infant long before discharge.
Other Name: FICare
No Intervention: FICare Control Group
Study participants received standard care while their infant(s) was/were admitted to a Level II NICU.
- Global development [ Time Frame: At 18-months corrected age ]Ages and Stages Questionnaire, 3rd edition
- Infant social and emotional development [ Time Frame: At 18-months corrected age ]Ages and Stages Questionnaire:Social-Emotional, 2nd edition; Brief Infant Toddler Social Emotional Assessment
- Number of emergency room visits [ Time Frame: At 18-months corrected age ]Provincial healthcare administrative databases
- Number of re-admissions to hospital [ Time Frame: At 18-months corrected age ]Provincial healthcare administrative databases
- Number of unplanned visits to physician or other provider [ Time Frame: At 18-months corrected age ]Provincial healthcare administrative databases
- Number of antibiotic prescriptions [ Time Frame: At 18-months corrected age ]Number of antibiotic prescriptions will be compromised of maternal self-report data, and from the infant chart as collected the provincial healthcare provider in Alberta, Canada. A data disclosure agreement has been executed such that AHS Analysts with the Analytics, Data Integration, Measurement & Reporting (DIMR) team will link FICare data with antibiotic prescriptions from infant discharge home to 18 months corrected age. The number antibiotics prescribed will be summed to provide a total number of antibiotic prescriptions.
- General self-efficacy in parenting [ Time Frame: At 18-months corrected age ]
General Self-Efficacy Scale (GSE): A self-administered scale that assesses a general sense of perceived self-efficacy. Self-efficacy as it relates to parenting is addressed by including items in the participant questionnaire related to parenting.
Responses are made on a 4-point scale. Sum up the responses to all 10 items to yield the final composite score with a range from 10 to 40. There are no sub-scales and no recoding is required. There is no cut-off score, therefore individuals are not categorized as high or low self-efficacious. The GSE score can be correlated with other traits such as anxiety, and depression.
- Parenting stress [ Time Frame: At 18-months corrected age ]
A 36-item scale, captures general parenting stress and three subscales of Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child.
Responses 1, 2, 3, 7, 8, 9 and 11 are summed for Defensive Responding. Subscale scores are calculated by summing response items 1-12 for Parental Distress, items 13 - 24 for Parent-Child Dysfunctional Interaction, and items 25 - 36 for Difficult Child. Total Stress score is calculated by summing the raw scores of the subscales.
Raw scores are converted to T scores and percentiles. Normal range for scores is within the 16th to 84th percentiles. Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.
- Maternal-reported toddler sleep [ Time Frame: At 18-months corrected age ]Extended Brief Infant Sleep Questionnaire
- Direct industry costs (hospital costs, excluding housekeeping, maintenance, planning and physician times). [ Time Frame: At 18-months corrected age ]Provincial healthcare administrative databases
- State Anxiety [ Time Frame: At 18-months corrected age ]Two sub-scales: 1) long-standing quality of trait anxiety (20 items), and 2) the temporary condition of state anxiety (20 items). Items are rated on a 4-point scale. Item scores are added to obtain subtest total scores. Scoring is reversed for anxiety-absent items (19/40 items). Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the state anxiety scale. Normative values are available in the manual. Trait anxiety was collected previously in the FICare cRCT (NCT02879799) therefore, only state anxiety will be collected at 18 months.
- Depression [ Time Frame: At 18-months corrected age ]
Centre for Epidemiologic Studies Depression Scale Revised (CESD-R): This scale is a 20 item self-report measure of depression. A 5-point Likert scale measures symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition: (1) Sadness; (2) Loss of Interest; (3) Appetite; (4) Sleep; (5) Thinking/Concentration; (6) Guilt; (7) Tired; (8) Movement; and (9) Suicidal Ideation. The total score is calculated as a sum of responses to all 20 questions. The range of possible scores is between 0 and 60.
Internal consistency (0.92) was high, and the CESD-R is highly correlated with the score for the original CESD (Pearson correlation coefficient 0.89), the latter of which has an internal consistency of 0.85 - 0.90, and test-retest reliability of 0.45 - 0.70.
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): NCT03337659
|University of Calgary|
|Calgary, Alberta, Canada, T2N1N4|
|Principal Investigator:||Abhay Lodha, MD||University of Calgary|
|Principal Investigator:||Khalid Aziz, MD||University of Alberta|
|Principal Investigator:||Vibhuti Shah, MD||University of Toronto|