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A Cluster Randomized Controlled Trial of FICare at 18 Months

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. Identifier: NCT03337659
Recruitment Status : Enrolling by invitation
First Posted : November 9, 2017
Last Update Posted : April 16, 2019
Canadian Institutes of Health Research (CIHR)
University of Toronto
University of Alberta
Alberta Health Services
Information provided by (Responsible Party):
Karen Benzies, University of Calgary

Brief Summary:
In Alberta, one in every twelve babies is born preterm. Compared with their full term counterparts, preterm infants who survive are at higher risk for respiratory problems, jaundice, infections, feeding problems, behavioural problems, and neuro-developmental disabilities, including cognitive delays, and visual and hearing impairments. As a result, parents must leave their preterm babies in the hospital to fully develop enough to care for them at home. When it is time for discharge, parents are often unprepared to look after their baby because they may have limited involvement in the care of their baby in hospital. In addition to the distress and costs to parents of having a baby in hospital, health system costs are also increased the longer a baby is in hospital. The aim of this novel health services study is to assess the longer-term outcomes and costs, to 18 months corrected age, of Family Integrated Care (FICare) for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). A cluster randomized controlled trial (cRCT) of FICare is currently in progress. FICare is a psycho-educational intervention that empowers parents (mothers and fathers) to sequentially build their knowledge, skill, and confidence so the family is well-prepared to care for their preterm infant before discharge. The FICare cRCT evaluates outcomes related to infant global development and maternal psychosocial distress at 2 months. At 2 months, it is difficult to predict longer term outcomes for moderate and late preterm infants. A follow-up study at 18 months will provide evidence of the sustainability of any effects, and longer-term cost savings upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.

Condition or disease Intervention/treatment Phase
Premature Birth Other: Family Integrated Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 422 participants
Allocation: Randomized
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Global development [ Time Frame: At 18-months corrected age ]
    Ages and Stages Questionnaire, 3rd edition

Secondary Outcome Measures :
  1. 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

  2. Number of emergency room visits [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases

  3. Number of re-admissions to hospital [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases

  4. Number of unplanned visits to physician or other provider [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases

  5. 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.

  6. 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.

  7. 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.

  8. Maternal-reported toddler sleep [ Time Frame: At 18-months corrected age ]
    Extended Brief Infant Sleep Questionnaire

  9. Direct industry costs (hospital costs, excluding housekeeping, maintenance, planning and physician times). [ Time Frame: At 18-months corrected age ]
    Provincial healthcare administrative databases

  10. 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.

  11. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mothers of infants born between 32 weeks and zero days and 34 weeks and 6 days gestation who enrolled in the FICare Alberta Level II NICU cluster controlled trial (cRCT). The FICare cRCT enrolled mothers of any age who have decision making capacity; mothers who are able to speak, read and understand English well enough to provide informed consent, and complete surveys online or via telephone.

Exclusion Criteria:

  • The FICare Alberta Level II NICU cRCT excluded mothers whose infants have serious congenital or chromosomal anomalies that require surgery, or are receiving palliative care; mothers who are not able to communicate in English; mothers with complex social issues.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03337659

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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N1N4
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
University of Toronto
University of Alberta
Alberta Health Services
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Principal Investigator: Abhay Lodha, MD University of Calgary
Principal Investigator: Khalid Aziz, MD University of Alberta
Principal Investigator: Vibhuti Shah, MD University of Toronto

Hack M, Wilson-Costello D. Follow-up outcomes of high risk infants. In: Buonocore G, Bracci R, Weindling M, eds. Neonatology: A practical approach to neonatal diseases: Springer; 2012:122-129.
March of Dimes, PMNCH, Save the Children, WHO. Born too soon: The global action report on preterm birth. Geneva: World Health Organization;2012.
World Health Organization. Preterm birth fact sheet. 2015;
Alberta Health and Wellness. Interactive Health Data Application, 2015 reproductive health data set. 2015;
Canadian Institute for Health Information. Highlights of 2010-2011 selected indicators describing the birthing process in Canada. Canadian Institute for Health Information;2012.
Tough S, Tofflemire K, Newburn-Cook C, Fraser-Lee N, Benzies K. Increased risks of pregnancy complications and adverse infant outcomes associated with assisted reproduction. International Congress Series. Research Papers in Fertility and Reproductive Medicine. Proceedings of the 18th World Congress on Fertility and Sterility (IFFS 2004). 2004;1271:376-379.
Dean S. Child Health Strategic Clinical Network meeting: Reporting and analytics. Calgary, AB: Alberta Health Services; 2012.
Kolb B, Whishaw IQ, Teskey GC. An introduction to brain and behavior. New York, NY: Worth Publishers; 2016.
Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy Scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Casual and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON.
Eaton WW, Muntaner C, Smith C, Tien A, Ybarra M. Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R). In: Maruish ME, ed. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment. 3rd ed. Mahwah, NJ: Lawrence Erlbaum; 2004:363-377.
Radloff, L. S. (1977). The CES-D scale: A self report depression scale for research in the general population. Applied Psychological Measurements, 1, 385-401.
Spielberger CD, Gorsuch RL, Lushene RE. Test manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1970.
Abidin RR. Parenting Stress Index - Fourth Edition - Short Form. Lutz, FL: Psychological Assessment Resources; 2012.
Eaton WW, Smith C, Ybarra M, Muntaner C, Tien A. Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R). In: Maruish ME, ed. The use of psychological testing for treatment planning and outcomes assessment: Volume 3 - Instruments for adults. Mahwah, NJ: Lawrence Erlbaum Associates; 2004:363-377.
Schwarzer R, Jerusalem M. Generalized Self-Efficacy Scale. In: Weinman J, Wright S, Johnston M, eds. Measures in health psychology: A user's portfolio. Causal and control beliefs. Windsor, UK: NEFR-NELSON; 1995:35-37.

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Responsible Party: Karen Benzies, Professor; Associate Dean, Research, University of Calgary Identifier: NCT03337659     History of Changes
Other Study ID Numbers: CIP-150740
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Discussions are underway to draft a data deposition agreement with Secondary Analyses to Generate Evidence (SAGE).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Benzies, University of Calgary:
Family-integrated care
neonatal intensive care unit
infant development
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications