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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Self Efficacy Infant Development eHealth Mental Health Wellness 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

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Control Group with Standard Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group Receiving 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.

Group Type EXPERIMENTAL

CNH+

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

Interventions

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes