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NCT Number: NCT06618586

Get Social Media and Risk-Reduction Training

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.

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Key information

Conditions

Infant Death Death Death, Sudden Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Infant Death

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston University

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Sarah Roth

CONTACT

[email protected]

617-734-6006

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TodaysBaby

Behavioral

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 .

Primary outcomes

  1. Penetration of sign up for TodaysBaby

    Time frame: First week after birth

    Rate of sign up for TodaysBaby among mothers that sign up during the different implementation strategies

  2. Equity of sign up for TodaysBaby

    Time frame: First week after birth

    Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies

Secondary outcomes

  1. Feasibility of implementation

    Time frame: Within a year of participant enrollment (qualitative) and >60 day after birth survey

    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

  2. Acceptability

    Time frame: Within a year of participant enrollment

    Staff perception that the delivery of the implementation strategies was satisfactory (measured through semi-structured interviews)

  3. Sustainability

    Time frame: Within a year of participant enrollment (qualitative) and during the 6-month study implementation periods

    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

  4. Fidelity

    Time frame: First 60 days after birth

    Number of videos viewed by mother, divided by total videos among mothers enrolled in the different implementation strategies

  5. Effectiveness of TodaysBaby on safe sleep practices

    Time frame: 60-180 days (average 80 days) after birth survey

    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

  6. Program cost of TodaysBaby

    Time frame: 60-180 days during the program sign up periods.

    Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Roth, MPH

CONTACT

[email protected]

(617)206-6198

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Boston Medical Center
  • Boston University
  • Columbia University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Colorado, Denver
  • University of Massachusetts, Worcester
  • Washington University School of Medicine

Registry information

Official study title

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

Acronym: GETSMART

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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