Clinical trial NCT06618586: Get Social Media and Risk-Reduction Training
Official title: Get Social Media and Risk-Reduction Training (GET SMART)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant Death
Sudden Infant Death
Keywords: Safe Sleep
Mobile Messaging
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: Boston Medical Center
name: Boston University
name: University of Massachusetts, Worcester
name: Columbia University
name: University of Colorado, Denver
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-10-01
Enrollment: 10000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a hybrid type 3 implementation-effectiveness cluster randomized trial at 20 US birth hospitals. In a crossover design separated by a 1-month washout period, we will test 2 strategies for recruitment of mothers into the 2-month-long TodaysBaby mobile safe sleep education program: 1) The original TodaysBaby implementation strategy (HT), in which hospital staff recruit mothers and view the first 2 videos with them; and 2) A new low-touch (LT) hospital implementation strategy, in which mothers are attracted to TodaysBaby through direct-to-consumer marketing and sign themselves up using a QR code.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Penetration of sign up for TodaysBaby
timeFrame: First week after birth
measure: Equity of sign up for TodaysBaby
timeFrame: First week after birth
Secondary outcomes:
measure: Feasibility of implementation
timeFrame: Within a year of participant enrollment (qualitative) and >60 day after birth survey
measure: Acceptability
timeFrame: Within a year of participant enrollment
measure: Sustainability
timeFrame: Within a year of participant enrollment (qualitative) and during the 6-month study implementation periods
measure: Fidelity
timeFrame: First 60 days after birth
measure: Effectiveness of TodaysBaby on safe sleep practices
timeFrame: 60-180 days (average 80 days) after birth survey
measure: Program cost of TodaysBaby
timeFrame: 60-180 days during the program sign up periods.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: University of Virginia School of Medicine
name: Rachel Y Moon, MD
role: PRINCIPAL_INVESTIGATOR
References: