Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorIWK Health Centre
About this trial
Preterm infants, 1 in 12 Canadian births, are at a significant increased risk of poor health outcomes, resulting in high healthcare burden. Parents of these infants report lower self-efficacy and worse mental health when compared to parents of term infants. There is an urgent need to use effective ways to improve parental self-efficacy and associated parent psychosocial and infant health outcomes. To improve parent and baby outcomes, the investigators will build on an existing eHealth solution to create Chez NICU Home+ (CNH+), which offers web-based, parent-targeted, interactive educational tools, virtual communication, and text message support during a baby's NICU stay. We will evaluate whether Chez NICU Home+ improves parental self-efficacy (primary outcome), parent psychosocial, and infant health outcomes in parents of babies requiring a NICU stay, and the implementation (ease and uptake) of Chez NICU Home+ in multiple sites. This study will be a multicentre implementation study, with a stepped wedge cluster randomized controlled trial across four Canadian NICUs. At the beginning of the study, data regarding current care will be collected from all sites to determine a baseline. Following baseline data collection, every five months one of the sites will start using the Chez NICU Home+ solution. A total of 600 parents and their babies, who are expected to stay at least 14 days in the NICU, will be recruited. Parents will complete a survey on psychosocial adjustment and infant outcomes when the study begins, as well as at 14 and 21 days after enrollment, at infant discharge from the NICU, and at 6 months post-discharge. Infant health and development outcomes will be collected at discharge, 6 and 18 months post-discharge via health records. The investigators predict that Chez NICU Home+ will be a positive, interactive care option, combining virtual parent education, tailored communication, and support, which will improve parental self-efficacy and parent psychosocial and infant health outcomes, and have long-term benefits for families.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Parents who have an infant admitted to the NICU
Parents who provide consent to participate within 7 days following birth
Infant (regardless of gestational age or diagnosis) is anticipated to have at least a 14-day NICU stay
Disqualifiers
Parents who are unable to read or write English
Parents whose infant is not anticipated to survive within the 7-day enrollment period after birth based on attending physician assessment
Trial design
Design model
Parallel
Treatments tested in this trial
CNH+
BehavioralCNH+ is a bundled intervention targeting all four of Bandura's factors associated with improved self-efficacy (i.e., Mastery \[evidence-based parent targeted education platform\]; Vicarious Experience \[observing other families similar to them succeeding in a task i.e., videos and photos\]; Verbal Persuasion \[in-person/virtual medical rounds and provision of social support\]; and Physiological States \[notifications and encouragement through mHealth text messaging, parent feedback, and tailored clinical care pathway\]).
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Control Group with Standard CareNo intervention 0 interventions
Group B: Intervention Group Receiving CNH+Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental self-efficacy at their infant's discharge from the NICU? Measured using the Perceived Maternal Parenting Self-Efficacy (PMPS-E) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. All primary parent/caregiver(s) (up to 3) will be asked to complete this measure. The PMPS-E has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of parental self-efficacy).
Time frame
At baseline and immediately after the infant is discharged from the NICU (the end of in-hospital phase)2
Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at 21 days (after the infant is born)
In parents of NICU infants, does CNH+, when compared to standard care, change parental self-efficacy? Measured using the Perceived Maternal Parenting Self-Efficacy (PMPS-E) tool at enrollment (baseline) and 21 days after the infant admitted to the NICU is born. All primary parent/caregiver(s) (up to 3) will be asked to complete this measure. The PMPS-E has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of parental self-efficacy).
Time frame
At baseline, discharge to another unit (if eligible), and 21 days after the infant is born3
Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at 6 months (after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental self-efficacy 6 months after the infant is discharged from the NICU? Measured using the Perceived Maternal Parenting Self-Efficacy (PMPS-E) tool at enrollment, and 6 months after the infant is discharged from the NICU. All primary parent/caregiver(s) (up to 3) will be asked to complete this measure. The PMPS-E has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of parental self-efficacy).
Time frame
At baseline and 6 months after the infant is discharged from the NICUSecondary outcomes
1
Change from baseline parental level of stress (as measured using the State Trait Anxiety Inventory tool) at infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level of stress at their infant's discharge from the NICU? Measured using the State Trait Anxiety Inventory (STAI) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. The primary parent/caregiver(s) will be asked to complete this measure. The STAI has a minimum score of 20 and a maximum score of 80. A higher score indicates a worse outcome (higher levels of parental anxiety).
Time frame
At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)2
Change from baseline parental level of stress (as measured using the State Trait Anxiety Inventory tool) at 21 days (after the infant is born)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level of stress at 21 days after the infant is born? Measured using the State Trait Anxiety Inventory (STAI) tool at enrollment (baseline) and at 21 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The STAI has a minimum score of 20 and a maximum score of 80. A higher score indicates a worse outcome (higher levels of parental anxiety).
Time frame
At baseline and at 21 days (after the infant is born)3
Change from baseline parental level of NICU-specific stressors (as measured using the Parental Stressor Scale tool) at infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level of NICU-specific stressors at their infant's discharge from the NICU? Measured using the Parental Stressor Scale (PSS NICU) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. The primary parent/caregiver(s) will be asked to complete this measure. The PSS NICU has a minimum score of 18 and a maximum score of 90. A lower score indicates a better outcome (lower levels of parental NICU-specific stress).
Time frame
At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)4
Change from baseline parental level of NICU-specific stressors (as measured using the Parental Stressor Scale tool) at 21 days (after the infant is born)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level of NICU-specific stressors at 21 days after the infant is born? Measured using the Parental Stressor Scale (PSS NICU) tool at enrollment (baseline) and at 21 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The PSS NICU has a minimum score of 18 and a maximum score of 90. A lower score indicates a better outcome (lower levels of parental NICU-specific stress).
Time frame
At baseline and at 21 days (after the infant is born)Sponsors and contacts
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IWK Health Centre
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov