Infant DeathGETSMARTNCT06618586
Get Social Media and Risk-Reduction Training
A study testing TodaysBaby in people with Infant Death and Sudden Infant Death, run by University of Virginia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant Death, Sudden Infant Death
- What is being tested?
- TodaysBaby
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston University
Boston, Massachusetts, 02118
Sarah Roth, 617-734-6006, saroth@bu.edu
About this study
Official title: 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.
- Conditions
- Infant Death, Sudden Infant Death
- Being tested
- TodaysBaby
- Keywords
- Safe Sleep, Mobile Messaging
- Medical subject headings
- Infant Death, Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TodaysBabyBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| New low touch (LT) hospital implementation strategy | Experimental | 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. Receives: Behavioral: TodaysBaby |
| Original high touch (HT) hospital implementation strategy | Active comparator | 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. Receives: Behavioral: TodaysBaby |
| Control- Standard of Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Penetration of sign up for TodaysBaby
Rate of sign up for TodaysBaby among mothers that sign up during the different implementation strategies
Measured: 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
Measured: First week after birth
Secondary outcomes (6)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 60-180 days during the program sign up periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 May 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, Boston Medical Center, Boston University, University of Massachusetts, Worcester, Columbia University, University of Colorado, Denver, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Rachel Moon, MD, University of Virginia
- Investigators
- Rachel Y Moon, MD, Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618586
- Sponsor's protocol ID
- 202401227
- Other IDs
- R01HD110568-01A1
- Acronym
- GETSMART
- Status last verified
- Jun 2025
- First submitted
- 27 Aug 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 birth hospitals. BMC Pediatr. 2026 Mar 11;26(1):346. doi: 10.1186/s12887-026-06715-8.
PubMed 41814244
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Social Media and Risk-Reduction Training (GET SMART)
- ClinicalTrials.gov ID
- NCT06618586
- Acronym / sponsor ID
- GETSMART / 202401227
- Conditions
- Infant Death, Sudden Infant Death
- Keywords
- Safe Sleep, Mobile Messaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, Boston Medical Center, Boston University, University of Massachusetts, Worcester, Columbia University, University of Colorado, Denver, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| New low touch (LT) hospital implementation strategy | Experimental | Behavioral: TodaysBabyThis 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. |
| Original high touch (HT) hospital implementation strategy | Active comparator | Behavioral: TodaysBabyThis 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. |
| Control- Standard of Care | No intervention | –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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TodaysBabyThe 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 . | Behavioural | New low touch (LT) hospital implementation strategy, Original high touch (HT) hospital implementation strategy |
Primary outcome
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
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
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Derived from this study: PubMed 41814244Moon 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 birth hospitals. BMC Pediatr. 2026 Mar 11;26(1):346. doi: 10.1186/s12887-026-06715-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Y Moon, MD principal investigator
University of Virginia School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TodaysBaby in people with Infant Death and Sudden Infant Death, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Roth, MPH ((617)206-6198, saroth@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration of sign up for TodaysBaby (time frame: First week after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06618586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.