Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU

NCT05853666 | Unknown

• 1 other identifier: CONNECT 1028664
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief 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. 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 800 parents and their babies, who are expected to stay at least 5 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

Keywords

Neonatal; Parents; Families; eHealth; Implementation; Parent mental health; Infant outcomes; Parent presence

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  At baseline 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).

  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)

  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)

  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)

  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)

  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)

  At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)

Study Arms (2)

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.

Behavioral: CNH+

Interventions

CNH+ BEHAVIORAL

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 \[notifications and encouragement through mHealth text messaging, parent feedback, and tailored clinical care pathway\]).

Intervention Group Receiving CNH+

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 5-day NICU stay

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Officials

• Marsha Campbell-Yeo, RN NNP PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marsha Campbell-Yeo, RN NNP PhD

CONTACT

902 430 6447; marsha.campbell-yeo@dal.ca

Lynsey R Alcock, MPH MSc

CONTACT

902 470 2640; lynsey.alcock@iwk.nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants enrolled in the study will be allocated based on whether the NICU is in the control or intervention condition on their admission date. Blinding to the intervention at the participant level (i.e., standard care or CNH+) is not possible. Although an attention control website was considered, this was not implemented to ensure the findings are relevant against existing standard care (i.e., no eHealth component). Blinding is not possible at the unit level due to the shift in communication that will occur (e.g., virtual rounds). Blinding will occur during data analyses by using an external statistician not familiar with the group allocations. Examiners completing the 18-month neurodevelopment outcomes work at arm's length to the NICU with no or little knowledge of ongoing NICU studies.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dalhousie University, School of Nursing, Faculty of Health

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: May 11, 2023
• Study Start: June 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share