Social Media and Risk-reduction Training for Preterm Infant Care Practices

N/ANot Yet RecruitingNCT07420686

University of Massachusetts, Worcester1,600 enrolled

Overview

SMART Preemie is a cluster randomized trial that will investigate the effectiveness of NICU-based and post-discharge interventions to improve adherence to safe sleep practices among mothers of preterm infants. This study includes two complementary, culturally competent, intervention strategies and will test the effectiveness of each strategy, as well as both strategies in combination. The attention matched-control intervention will focus on shared reading. The SMART Preemie study will have four arms in which 16 hospitals are randomly assigned to one of the following study groups: 1) Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages; 2) Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages; 3) Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages; 4) Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages. A total of 1600 mothers will be recruited (100/hospital), with 400 in each study group. The primary aim is to assess the effectiveness of the interventions aimed at promoting safe sleep practices compared with the shared reading control interventions. The secondary aim is to assess potential mediating factors that may explain the intervention effects on infant care practices and that may inform areas for future improved intervention approaches. The tertiary aim is to assess key implementation outcomes which will be used for future scale-up. With the successful completion of the SMART Preemie study, effectiveness, mechanism, and implementation data will have been provided for two interventions to improve adherence to safe sleep practices that are practical to disseminate nationally in multiple diverse settings.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,600

Interventions

Safe Sleep NICU Quality Improvement CampaignBEHAVIORAL

We will train NICU staff working in hospitals randomized to the safe sleep intervention to: (1) Model safe sleep practices when infants achieve medical stability according to AAP guidelines ; and (2) Provide education to parents about safe sleep throughout the NICU hospitalization, as it relates to their infants reaching medical stability and readiness to be placed in supine positions in a sleep area without any unsafe objects in the NICU and in the home environment.

Shared Reading NICU Quality Improvement CampaignBEHAVIORAL

We will train NICU staff working in hospitals randomized to the shared reading intervention to: 1. Model shared reading practices with book distribution, and 2. Provide education to parents about shared reading. Hospital staff may use any materials from our toolkits as needed and we ask for staff to provide education to parents, and model shared reading, when distributing a new book to the family within the first week of admission, and then every 2 weeks while their child is in the NICU.

Safe Sleep TodaysNICUBaby videos and messagesBEHAVIORAL

The TodaysNICUBaby mHealth program is comprised of: 1. text message-delivered, short educational videos in the first 8 weeks after NICU discharge and 2. text queries regarding safe sleep or shared reading practices, which collect data on these practices in near real-time and provide reinforcement of adherence.

Shared Reading TodaysNICUBaby videos and messagesBEHAVIORAL

The Shared Reading TodaysNICUBaby mHealth program is comprised of: 1. text message-delivered, short educational videos in the first 8 weeks after NICU discharge and 2. text queries regarding shared reading, which collect data on these practices in near real-time and provide reinforcement of adherence.

Eligibility

Sex: FEMALEMin age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * English- or Spanish- speaking mothers of preterm infants (gestational age \<37 weeks' weeks) * Infant must have been admitted to one of the 16 participating NICUs for at least 7 days * Infant must be discharged home from one of the 16 participating NICUs within 56 weeks post-menstrual age (\>95% of preterm infants) * Infant must be discharged to the care of the mother (not a foster family) who intends to care for the child in the US for the first 6 months post-discharge * Must have a phone that can receive text messages and view videos Exclusion Criteria: * Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process. * Infant has contraindications to safe sleep positioning (e.g. extremely rare conditions of the airway or lower spine) * Meets the definition of a minor according to applicable state law.

Locations (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

Impact of the NICU safe sleep intervention on safe infant sleep position

Percent with exclusive supine sleep in the previous 2 weeks

Time frame: 60 days post-discharge

Impact of the NICU safe sleep intervention on safe infant sleep location

Percent with exclusive room sharing without bedsharing in the previous 2 weeks

Time frame: 60 days post-discharge

Impact of the NICU safe sleep intervention safe sleep space

Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)

Time frame: 60 days post-discharge

Impact of the NICU safe sleep intervention on safe infant sleep environment

Percent with absence of loose objects in the sleep area in the previous 2 weeks

Time frame: 60 days post-discharge

Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep position

Percent with exclusive supine sleep in the previous 2 weeks

Time frame: 60 days post-discharge

Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep location

Percent with exclusive room sharing without bedsharing in the previous 2 weeks

Time frame: 60 days post-discharge

Impact of the mHealth post-discharge safe sleep intervention safe sleep space

Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)

Time frame: 60 days post-discharge

Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep environment

Percent with absence of loose objects in the sleep area in the previous 2 weeks

Time frame: 60 days post-discharge

Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep position

Percent with exclusive supine sleep in the previous 2 weeks

Time frame: 60 days post-discharge

Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep location

Percent with exclusive room sharing without bedsharing in the previous 2 weeks

Time frame: 60 days post-discharge

Impact of the NICU and mHealth post-discharge safe sleep intervention safe sleep space

Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)

Time frame: 60 days post-discharge

Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep environment

Percent with absence of loose objects in the sleep area in the previous 2 weeks

Time frame: 60 days post-discharge

Secondary Outcomes

Safe infant sleep position by maternal race/ethnicity

Percent with exclusive supine sleep in the previous 2 weeks, by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)

Time frame: 60 days post-discharge

Safe infant sleep location by maternal race/ethnicit

Percent with exclusive room sharing without bedsharing in the previous 2 weeks by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)

Time frame: 60 days post-discharge

Safe sleep space by maternal race/ethnicity

Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.) by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)

Time frame: 60 days post-discharge

Safe infant sleep environment by maternal race/ethnicity

Percent with absence of loose objects in the sleep space in the previous 2 weeks by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)

Time frame: 60 days post-discharge

Safe infant sleep position by infant gestational age

Percent with exclusive supine sleep in the previous 2 weeks, by infant gestational age (\<29 weeks vs 29-36 weeks)

Time frame: 60 days post-discharge

Safe infant sleep location by infant gestational age

Percent with exclusive room sharing without bedsharing in the previous 2 weeks infant gestational age (\<29 weeks vs 29-36 weeks)

Time frame: 60 days post-discharge

Safe sleep space by infant gestational age

Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.) infant gestational age (\<29 weeks vs 29-36 weeks)

Central Contacts

Margaret Parker, MD, MPH

CONTACT

5083343180 Margaret.Parker@umassmemorial.org

Mayra Rojas, BS

CONTACT

5083343180 mayra.rojascorrea@umassmed.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 60 days post-discharge

Safe infant sleep environment by infant gestational age

Percent with absence of loose objects in the sleep space in the previous 2 weeks by infant gestational age (\<29 weeks vs 29-36 weeks)

Time frame: 60 days post-discharge

Impact of the NICU safe sleep intervention on intention for safe infant sleep position

Percent with intention for exclusive supine sleep after NICU discharge

Time frame: Baseline and 60 days post-discharge

Impact of the NICU safe sleep intervention on intention for safe infant sleep location

Percent with intention for exclusive room sharing without bedsharing after NICU discharge

Time frame: Baseline and 60 days post-discharge

Impact of the NICU safe sleep intervention on intention for safe infant safe sleep space

Percent with intention for exclusive sleep in a crib/bassinet after NICU discharge (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)

Time frame: Baseline and 60 days post-discharge

Impact of the NICU safe sleep intervention on intention for safe infant sleep environment

Percent with intention for no loose objects in the sleep area after NICU discharge

Time frame: Baseline and 60 days post-discharge

Impact of the mHealth post-discharge sleep intervention on intention for safe infant sleep position

Percent with intention for exclusive supine sleep after NICU discharge

Time frame: 60 days post-discharge

Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep location

Percent with intention for exclusive room sharing without bedsharing after NICU discharge

Time frame: 60 days post-discharge

Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space

Percent with intention for exclusive sleep in a crib/bassinet after NICU discharge (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)

Time frame: 60 days post-discharge

Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment

Percent with intention for no loose objects in the sleep area after NICU discharge

Time frame: 60 days post-discharge

Impact of the NICU and mHealth post-discharge sleep intervention on intention for safe infant sleep position

Percent with intention for exclusive supine sleep after NICU discharge

Time frame: 60 days post-discharge

Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep location

Percent with intention for exclusive room sharing without bedsharing after NICU discharge

Time frame: 60 days post-discharge

Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space

Percent with intention for exclusive sleep in a crib/bassinet after NICU discharge (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)

Time frame: 60 days post-discharge

Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment

Percent with intention for no loose objects in the sleep area after NICU discharge

Time frame: 60 days post-discharge

Impact of the NICU safe sleep intervention on time to unsafe sleep position

Time to place infant in an unsafe sleep position (any side or prone)

Time frame: 0 to 60 days post-discharge

Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep position

Time to place infant in an unsafe sleep position (any side or prone)

Time frame: 0 to 60 days post-discharge

Impact of the NICU and mHealth post-discharge safe sleep intervention on time to unsafe sleep position

Time to place infant in an unsafe sleep position (any side or prone)

Time frame: 0 to 60 days post-discharge

Impact of the NICU safe sleep intervention on time to unsafe sleep location

Time to place infant in an unsafe sleep location (any bedsharing)

Time frame: 0 to 60 days post-discharge

Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep location

Time to place infant in an unsafe sleep location (any bedsharing)

Time frame: 0 to 60 days post-discharge

Impact of the NICU and mHealth post-discharge safe sleep intervention on unsafe sleep location

Time to place infant in an unsafe sleep location (any bedsharing)

Time frame: 0 to 60 days post-discharge

Impact of the NICU shared reading intervention on reading

Score on the READ scale of the STIM-Q

Time frame: 60 days post-discharge

Impact of the post-discharge mHealth shared reding intervention on reading

Score on the READ scale of the STIM-Q

Time frame: 60 days post-discharge

Impact on the NICU and post-discharge mHealth shared reading interventions on reading

Score on the READ scale of the STIM-Q

Time frame: 60 days post-discharge

Impact of the NICU shared reading intervention on early relational health

Score on the post-partum bonding questionnaire

Time frame: 60 days post-discharge

Impact of the post-discharge mHealth shared reding intervention on early relational health

Score on the post-partum bonding questionnaire

Time frame: 60 days post-discharge

Impact on the NICU and post-discharge mHealth shared reading interventions on early relational health

Score on the post-partum bonding questionnaire

Time frame: 60 days post-discharge

Reading by maternal race/ethnicity

Score on the READ scale of the STIM-Q by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)

Time frame: 60 days post-discharge

Early relational health by race/ethnicity

Score on the READ scale of the STIM-Q by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)

Time frame: 60 days post-discharge

Reading by infant gestational age

Score on the post-partum bonding questionnaire by infant gestational age ( \<29 weeks vs 29-36 weeks)

Time frame: 60 days post-discharge

Early relational health by infant gestational age

Score on the post-partum bonding questionnaire by infant gestational age (\<29 weeks vs 29-36 weeks)

Time frame: 60 days post-discharge

Feasibility of NICU interventions

Mean score reported by NICU staff on the Feasibility of Intervention Measure (FIM), a 4-item measure of perceived intervention feasibility

Time frame: In year 4-5 of study period, after completion of enrollment on subjects

Acceptability of NICU interventions

Mean score reported by NICU staff on the Acceptability of Intervention Measure (AIM), a 4-item measure of perceived intervention acceptability. Scores are calculated as the mean

Time frame: In year 4-5 of study period, after completion of enrollment on subjects

Fidelity to NICU safe sleep intervention

Percentage of mothers reporting observed modeling of safe sleep practices (supine sleep position and absence of objects in the sleep environment) and receipt of safe sleep education while in the NICU

Time frame: Baseline

Fidelity to NICU shared reading intervention

Percentage of mothers reporting participation in shared reading and receipt of shared reading education while in the NICU

Time frame: Baseline

Fidelity to mHealth interventions

Percentage of videos opened by mothers as a proxy for videos watched

Time frame: Days 1-60 post-discharge

Social Media and Risk-reduction Training for Preterm Infant Care Practices

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts