Get Social Media and Risk-Reduction Training (GETSMART)

Get Social Media and Risk-Reduction Training (GET SMART)

This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention program in US hospitals. The main aims of this study are to examine: 1) differences in program penetration and the equity of penetration according to income and race/ethnicity; 2) differences in feasibility, acceptability, sustainability and fidelity top the intervention; and 3) the effectiveness of the intervention.

Study Overview

• Status: Recruiting
• Conditions: Sudden Infant Death; Infant Death
• Intervention / Treatment: Behavioral: TodaysBaby

• Study Type: Interventional
• Enrollment (Estimated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Roth, MPH; Phone Number: (617)206-6198; Email: saroth@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston University
      • Contact: Sarah Roth; Phone Number: 617-734-6006; Email: saroth@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Must speak English or Spanish
• Must live in the United States
• Must have given birth to a healthy, term infants (37 weeks or greater) and be discharged within 7 days of birth
• Must plan to care for infant and live in the same household as infant after birth
• Must enroll in the TodaysBaby program by the time their infant is 7 days of age

Exclusion Criteria:

• A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New low touch (LT) hospital implementation strategy; This will occur during either the first or second 6-month intervention time period (order randomly assigned). For the period of time hospitals are randomized into this arm mothers will be attracted to TodaysBaby through direct-to-consumer marketing and sign themselves up using a QR code. These mothers will also receive standard postpartum care.	Behavioral: TodaysBaby; The TodaysBaby intervention is comprised of: 1) Text message-delivered, short educational videos in the first 2 months after birth, with each video timed to match content addressing anticipated barriers and facilitators to adhering to guidelines (e.g. parental concerns that infant will choke while supine). Participants will also have access to a web portal where intervention videos will be maintained. 2) Text queries regarding safe sleep practices, which collect data on sleep practices in near real-time and provide reinforcement of adherence. Mothers will receive 1-2 text message questions weekly that assess sleep practices in near real-time .
Active Comparator: Original high touch (HT) hospital implementation strategy; This will occur during either the first or second 6-month intervention time period (order randomly assigned). For the period of time hospitals are randomized into this arm hospital staff will help mothers sign up and view the first 2 TodaysBaby in a one-on-one conversation format. These mothers will also receive standard postpartum care.	Behavioral: TodaysBaby; The TodaysBaby intervention is comprised of: 1) Text message-delivered, short educational videos in the first 2 months after birth, with each video timed to match content addressing anticipated barriers and facilitators to adhering to guidelines (e.g. parental concerns that infant will choke while supine). Participants will also have access to a web portal where intervention videos will be maintained. 2) Text queries regarding safe sleep practices, which collect data on sleep practices in near real-time and provide reinforcement of adherence. Mothers will receive 1-2 text message questions weekly that assess sleep practices in near real-time .
No Intervention: Control- Standard of Care; During the 3 months immediately prior to the first intervention time period, hospitals will recruit approximately 100 mothers to complete surveys regarding infant care practices. These mothers will also receive postpartum standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penetration of sign up for TodaysBaby	Rate of sign up for TodaysBaby among mothers that sign up during the different implementation strategies	First week after birth
Equity of sign up for TodaysBaby	Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies	First week after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementation	Staff perception that the implementation strategies were successfully used or carried out (measured through semi-structured interviews; Rate of maternal report that signing up for TodaysBaby was simple and fast	Within a year of participant enrollment (qualitative) and >60 day after birth survey
Acceptability	Staff perception that the delivery of the implementation strategies was satisfactory (measured through semi-structured interviews)	Within a year of participant enrollment
Sustainability	Staff perception that the implementation strategies could continue to be delivered after the end of the study (measured through semi-structured interviews); monthly penetration rates	Within a year of participant enrollment (qualitative) and during the 6-month study implementation periods
Fidelity	Number of videos viewed by mother, divided by total videos among mothers enrolled in the different implementation strategies	First 60 days after birth
Effectiveness of TodaysBaby on safe sleep practices	We will measure 4 sleep practices in the past 2 weeks among mothers enrolled in the different implementation strategies: Sleep position: % reporting supine position only Sleep location: % reporting roomsharing not bedsharing only Soft bedding: % reporting no soft bedding in sleep space Pacifier: % reporting usual pacifier use when infant sleeping	60-180 days (average 80 days) after birth survey
Program cost of TodaysBaby	Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies	60-180 days during the program sign up periods.

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Boston University; University of Colorado, Denver; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Washington University School of Medicine; Columbia University; Boston Medical Center; University of Massachusetts, Worcester
• Investigators: Principal Investigator: Rachel Y Moon, MD, University of Virginia School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Mobile Messaging; Safe Sleep
• Additional Relevant MeSH Terms: Pathologic Processes; Death, Sudden; Death; Infant Death; Sudden Infant Death
• Other Study ID Numbers: 202401227; R01HD110568-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No