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Recruiting NCT06618586

Get Social Media and Risk-Reduction Training

No phase Interventional Infant Death Sudden Infant Death

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TodaysBaby.
Who it may be relevant to
Registry conditions: Infant Death, Sudden Infant Death. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 r

Primary outcome measures

  • Penetration of sign up for TodaysBaby [Time frame: First week after birth]
  • Equity of sign up for TodaysBaby [Time frame: First week after birth]
Secondary outcome measures (6)
  • Feasibility of implementation [Time frame: Within a year of participant enrollment (qualitative) and >60 day after birth survey]
  • Acceptability [Time frame: Within a year of participant enrollment]
  • Sustainability [Time frame: Within a year of participant enrollment (qualitative) and during the 6-month study implementation periods]
  • Fidelity [Time frame: First 60 days after birth]
  • Effectiveness of TodaysBaby on safe sleep practices [Time frame: 60-180 days (average 80 days) after birth survey]
  • Program cost of TodaysBaby [Time frame: 60-180 days during the program sign up periods.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Boston University — Boston

Publications

  • Moon RY, Hwang SS, Hauck FR, Kellams AL, Shafer PR, Colvin BN, Karpman H, Carlin RF, Corwin MJ, Colson E, Parker MG. Get Social Media and Risk-Reduction Training (GET SMART) to improve infant safe sleep practices through a mobile text message-delivered video safe sleep intervention for new parents: study protocol for a type 3 hybrid implementation-effectiveness cluster randomized trial in 20 US bi PMID 41814244

Identifiers

NCT: NCT06618586 · 202401227 · R01HD110568-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗