Self EfficacyNCT05853666
Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU
A study testing CNH+ in people with Self Efficacy and Infant Development, run by IWK Health Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy, Infant Development, eHealth
- What is being tested?
- CNH+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2023to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
IWK Health
Halifax, Nova Scotia, B3K 6R8
Cameron J Bruce, MSc, 9024970898, cameronj.bruce@iwk.nshealth.ca
Michael Narvey, MD
About this study
Official title: Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU Using an eHealth Solution (The CONNECT Study)
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.
- Conditions
- Self Efficacy, Infant Development, eHealth, Mental Health Wellness 1
- Being tested
- CNH+
- Keywords
- Neonatal, Parents, Families, eHealth, Implementation, Parent mental health, Infant outcomes, Parent presence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNH+Behavioural
CNH+ 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]).
| Study group | Role | What they receive |
|---|---|---|
| Control Group with Standard Care | No intervention | Consenting families in the NICU during the baseline control period will receive standard care as it is already provided at each site. Data collection procedures will mirror intervention groups to ensure comparable control data. |
| Intervention Group Receiving CNH+ | Experimental | Eligible consenting families (following enrollment) will be provided a secure login code and instructions to access the CNH+ educational modules and to send and receive virtual calls and text messages. Parents will be asked to use CNH+ during their entire NICU stay. To ensure equity, interested families without a personal device to access CNH+ will be offered a study-provided iPad for the duration of their infant's stay. Parents will have access to CNH+ while on the unit and 6 months post-discharge. Receives: Behavioral: CNH+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline and immediately after the infant is discharged from the NICU (the end of in-hospital phase)
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).
Measured: At baseline, discharge to another unit (if eligible), and 21 days after the infant is born
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).
Measured: At baseline and 6 months after the infant is discharged from the NICU
Secondary outcomes (43)
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).
Measured: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
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).
Measured: At baseline and at 21 days (after the infant is born)
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).
Measured: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
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).
Measured: At baseline and at 21 days (after the infant is born)
Change from baseline parental level of depression (as measured using the Postpartum Depression Screening 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 depression at their infant's discharge from the NICU? Measured using the Postpartum Depression Screening Scale (PDSS) 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 PDSS has a minimum score of 35 and a maximum score of 175. A higher score indicates a worse outcome (higher levels of postpartum depression).
Measured: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at 14 days (after the infant is born)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level depression at 14 days after the infant is born? Measured using the Postpartum Depression Screening Scale (PDSS) tool at enrollment (baseline) and at 14 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The PDSS has a minimum score of 35 and a maximum score of 175. A higher score indicates a worse outcome (higher levels of postpartum depression).
Measured: At baseline and at 14 days (after the infant is born)
Change from baseline parental level of depression (as measured using the Postpartum Depression Screening 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 depression at 21 days after the infant is born? Measured using the Postpartum Depression Screening Scale (PDSS) 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 PDSS has a minimum score of 35 and a maximum score of 175. A higher score indicates a worse outcome (higher levels of postpartum depression).
Measured: At baseline and at 21 days (after the infant is born)
Change from baseline parental quality of life (as measured using the Quality of Life (EQ-5D-5L) 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 quality of life at their infant's discharge from the NICU? Measured using the Quality of Life (EQ-5D-5L) 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 Quality of Life (EQ-5D-5L) has a descriptive score and a visual analog scale. The descriptive score has a minimum score of 5 and a maximum score of 25. A higher score indicates a worse outcome (lower levels of quality of life). The visual analog score has a minimum score of 0 and a maximum score of 100. A higher score indicates a better outcome (higher levels of quality of life).
Measured: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
Change from baseline parental quality of life (as measured using the Quality of Life (EQ-5D-5L) tool) at 21 days (after the infant is born)
In parents of NICU infants, does CNH+, when compared to standard care, change parental quality of life at 21 days after the infant is born? Measured using the Quality of Life (EQ-5D-5L) 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 Quality of Life (EQ-5D-5L) has a descriptive score and a visual analog scale. The descriptive score has a minimum score of 5 and a maximum score of 25. A higher score indicates a worse outcome (lower levels of quality of life). The visual analog score has a minimum score of 0 and a maximum score of 100. A higher score indicates a better outcome (higher levels of quality of life).
Measured: At baseline and at 21 days (after the infant is born)
Perceived amount of family-centred care in the NICU (as measured using the Family Centred Care 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 perceived amount of family-centred care in the NICU at their infant's discharge from the NICU? Measured using the Family Centred Care Scale tool immediately after the discharge from the NICU of the infant admitted to the NICU. The primary parent/caregiver(s) will be asked to complete this measure. The Family Centred Care Scale has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of perceived amount of family-centred care in the NICU).
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Perceived amount of family engagement in care in the NICU (as measured using the CO-PARTNER 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 perceived amount of family engagement in care in the NICU at their infant's discharge from the NICU? Measured using the CO-PARTNER Tool immediately after the discharge from the NICU of the infant admitted to the NICU. The primary parent/caregiver(s) will be asked to complete this measure. The CO-PARTNER Tool has a minimum score of 0 and a maximum score of 62. A higher score indicates a better outcome (higher levels of positive inherent relationship between participation and collaboration).
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Perceived parental readiness to have their infant discharged from the NICU and sent home (as measured using the Readiness for Hospital Discharge 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 perceived readiness to have their infant discharged from the NICU and sent home, at the time of their infant's discharge from the NICU? Measured using the Readiness for Hospital Discharge tool immediately after the discharge from the NICU of the infant admitted to the NICU. The primary parent/caregiver(s) will be asked to complete this measure. The Readiness for Hospital Discharge tool has a minimum average score of 0 and a maximum score of 10. A higher score indicates a better outcome (higher levels of readiness for hospital discharge).
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Infant weight growth (change in weight since birth) at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change infant weight growth (change in weight since birth) at the infant's discharge from the NICU? Data collected by chart review.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Infant head growth (change in head circumference since birth) at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change infant head growth (change in head circumference since birth) at the infant's discharge from the NICU? Data collected by chart review.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Infant length of stay in the NICU (in days) at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change infant length of stay in the NICU (in days) at the infant's discharge from the NICU? Data collected by chart review.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Amount of provision of mothers' own breast milk for their infant during their infant's stay in the NICU, totalled 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 the amount of provision of mothers' own breast milk for their infant during their infant's stay in the NICU? Data collected by chart review.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Infant receipt of breast milk 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 the receipt of breast milk for their infant at the infant's discharge from the NICU? Data collected by chart review.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Amount of time for the infant to reach full enteral feeds during their stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the amount of time for the infant to reach full enteral feeds during their stay in the NICU? Data collected by chart review.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of mortality during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the incidence of mortality during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of necrotizing enterocolitis (Stage >II) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the incidence of necrotizing enterocolitis (Stage >II) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of late-onset sepsis during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the incidence of late-onset sepsis during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of chronic lung disease during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the incidence of chronic lung disease during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of retinopathy of prematurity (Stage ≥3) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the incidence of retinopathy of prematurity (Stage ≥3) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of severe brain injury during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the incidence of severe brain injury during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of treated Patent Ductus Arteriosus (PDA) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the incidence of treated Patent Ductus Arteriosus (PDA) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of air leak during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the incidence of air leak during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of respiratory support (invasive and non-invasive) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the duration of respiratory support (invasive and non-invasive) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of oxygen supplementation during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the duration of oxygen supplementation during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of total parenteral nutrition (TPN) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the duration of total parenteral nutrition (TPN) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of hypoxic ischemic encephalopathy (HIE) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the duration of hypoxic ischemic encephalopathy (HIE) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Number of infant's days with a central venous line in situ during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the number of infant's days with a central venous line in situ during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Number of infant central line-associated bloodstream infections during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
In NICU infants, does CNH+, when compared to standard care, change the number of infant central line-associated bloodstream infections during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
Measured: At infant discharge date (immediately after the infant is discharged from the NICU)
Infant neurological examination score at 18 months corrected gestational age
In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through a neurological examination? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.
Measured: At 18 months of the infants corrected gestational age
Infant hearing assessment score at 18 months corrected gestational age
In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through a hearing assessment? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.
Measured: At 18 months of the infants corrected gestational age
Infant vision assessment score at 18 months corrected gestational age
In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through a vision assessment? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.
Measured: At 18 months of the infants corrected gestational age
Infant development score at 18 months corrected gestational age
In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through the Bayley Scales of Infant and Toddler Development? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.
Measured: At 18 months of the infants corrected gestational age
Number of Chez NICU Home educational modules completed at 6 months after the discharge of the infant from the NICU.
What number of Chez NICU Home educational modules are completed by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by the CNH platform.
Measured: At 6 months after the discharge of the infant from the NICU
Number of Chez NICU Home educational modules viewed at 6 months after the discharge of the infant from the NICU.
What number of Chez NICU Home educational modules are viewed by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by the CNH platform.
Measured: At 6 months after the discharge of the infant from the NICU
Amount of time spent on the Chez NICU Home platform at 6 months after the discharge of the infant from the NICU.
What amount of time do parents of infants in the NICU spend on the Chez NICU Home platform, at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by the CNH platform.
Measured: At 6 months after the discharge of the infant from the NICU
Number of text messages received by parents of infants in the NICU, completed at 6 months after the discharge of the infant from the NICU.
What number of text messages are received by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by TextIt application.
Measured: At 6 months after the discharge of the infant from the NICU
Number of virtual communication tools used by parents of infants in the NICU, completed at 6 months after the discharge of the infant from the NICU.
What number of virtual communication tools are used by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by CNH+.
Measured: At 6 months after the discharge of the infant from the NICU
Number of parents of infants in the NICU who enroll in CNH+ when offered?
What number of parents of infants in the NICU who enroll in CNH+ when offered at the beginning of the study?
Measured: At baseline (upon enrollment to the study)
Parents' perceived ease of use of the CNH+ intervention (as measured using the e-Health impact questionnaire) at 6 months after the discharge of the infant from the NICU)
In parents of NICU infants, what are parents' perceived ease of use of the CNH+ intervention at 6 months after the discharge of the infant from the NICU)? Measured using the e-Health impact questionnaire tool 6 months after the discharge of the infant from the NICU. The primary parent/caregiver(s) will be asked to complete this measure. When scored, the e-Health impact questionnaire tool has a minimum score of 0 and a maximum score of 100. A higher score indicates a better outcome (higher levels of perceived ease of use).
Measured: At 6 months after the discharge of the infant from the NICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start8 Sep 2023
- Primary completion31 May 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The CONNECT study is an unblinded multicentre stepped wedge cluster randomized controlled trial guided by a Hybrid-1 design examining the effectiveness and implementation of CNH+ compared to usual care (control) across four Canadian NICUs. All sites will begin in the control period (baseline). Every 5 months, one site will be randomized to CNH+ using a stepped wedge design allowing for 4 sites with 5 measurement steps.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Marsha Campbell-Yeo, IWK Health Centre
- Investigators
- Marsha Campbell-Yeo, RN NNP PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853666
- Sponsor's protocol ID
- CONNECT 1028664
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU Using an eHealth Solution (The CONNECT Study)
- ClinicalTrials.gov ID
- NCT05853666
- Acronym / sponsor ID
- CONNECT 1028664
- Conditions
- Self Efficacy, Infant Development, eHealth, Mental Health Wellness 1
- Keywords
- Neonatal, Parents, Families, eHealth, Implementation, Parent mental health, Infant outcomes, Parent presence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The CONNECT study is an unblinded multicentre stepped wedge cluster randomized controlled trial guided by a Hybrid-1 design examining the effectiveness and implementation of CNH+ compared to usual care (control) across four Canadian NICUs. All sites will begin in the control period (baseline). Every 5 months, one site will be randomized to CNH+ using a stepped wedge design allowing for 4 sites with 5 measurement steps.
| Arm | Type | Receives |
|---|---|---|
| Control Group with Standard Care | No intervention | –Consenting families in the NICU during the baseline control period will receive standard care as it is already provided at each site. Data collection procedures will mirror intervention groups to ensure comparable control data. |
| Intervention Group Receiving CNH+ | Experimental | Behavioral: CNH+Eligible consenting families (following enrollment) will be provided a secure login code and instructions to access the CNH+ educational modules and to send and receive virtual calls and text messages. Parents will be asked to use CNH+ during their entire NICU stay. To ensure equity, interested families without a personal device to access CNH+ will be offered a study-provided iPad for the duration of their infant's stay. Parents will have access to CNH+ while on the unit and 6 months post-discharge. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNH+CNH+ 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]). | Behavioural | Intervention Group Receiving CNH+ |
Primary outcome
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)
Time frame: At baseline and immediately after the infant is discharged from the NICU (the end of in-hospital phase)
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).
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)
Time frame: At baseline, discharge to another unit (if eligible), and 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).
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)
Time frame: At baseline and 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).
43 secondary outcomes
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)
Time frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
Change from baseline parental level of stress (as measured using the State Trait Anxiety Inventory tool) at 21 days (after the infant is born)
Time frame: At baseline and at 21 days (after the infant is born)
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)
Time frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
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)
Time frame: At baseline and at 21 days (after the infant is born)
Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at 14 days (after the infant is born)
Time frame: At baseline and at 14 days (after the infant is born)
Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at 21 days (after the infant is born)
Time frame: At baseline and at 21 days (after the infant is born)
Change from baseline parental quality of life (as measured using the Quality of Life (EQ-5D-5L) tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
Change from baseline parental quality of life (as measured using the Quality of Life (EQ-5D-5L) tool) at 21 days (after the infant is born)
Time frame: At baseline and at 21 days (after the infant is born)
Perceived amount of family-centred care in the NICU (as measured using the Family Centred Care Scale tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Perceived amount of family engagement in care in the NICU (as measured using the CO-PARTNER Tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Perceived parental readiness to have their infant discharged from the NICU and sent home (as measured using the Readiness for Hospital Discharge tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Infant weight growth (change in weight since birth) at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Infant head growth (change in head circumference since birth) at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Infant length of stay in the NICU (in days) at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Amount of provision of mothers' own breast milk for their infant during their infant's stay in the NICU, totalled at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Infant receipt of breast milk at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Amount of time for the infant to reach full enteral feeds during their stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of mortality during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of necrotizing enterocolitis (Stage >II) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of late-onset sepsis during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of chronic lung disease during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of retinopathy of prematurity (Stage ≥3) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of severe brain injury during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of treated Patent Ductus Arteriosus (PDA) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of air leak during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of respiratory support (invasive and non-invasive) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of oxygen supplementation during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of total parenteral nutrition (TPN) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of hypoxic ischemic encephalopathy (HIE) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Number of infant's days with a central venous line in situ during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Number of infant central line-associated bloodstream infections during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)
Infant neurological examination score at 18 months corrected gestational age
Time frame: At 18 months of the infants corrected gestational age
Infant hearing assessment score at 18 months corrected gestational age
Time frame: At 18 months of the infants corrected gestational age
Infant vision assessment score at 18 months corrected gestational age
Time frame: At 18 months of the infants corrected gestational age
Infant development score at 18 months corrected gestational age
Time frame: At 18 months of the infants corrected gestational age
Number of Chez NICU Home educational modules completed at 6 months after the discharge of the infant from the NICU.
Time frame: At 6 months after the discharge of the infant from the NICU
Number of Chez NICU Home educational modules viewed at 6 months after the discharge of the infant from the NICU.
Time frame: At 6 months after the discharge of the infant from the NICU
Amount of time spent on the Chez NICU Home platform at 6 months after the discharge of the infant from the NICU.
Time frame: At 6 months after the discharge of the infant from the NICU
Number of text messages received by parents of infants in the NICU, completed at 6 months after the discharge of the infant from the NICU.
Time frame: At 6 months after the discharge of the infant from the NICU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marsha Campbell-Yeo, RN NNP PhD principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CNH+ in people with Self Efficacy and Infant Development, run by IWK Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marsha Campbell-Yeo, RN NNP PhD (902 430 6447, marsha.campbell-yeo@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: At baseline and immediately after the infant is discharged from the NICU (the end of in-hospital phase)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.