Sudden Infant DeathGIFTSSNCT03186469
Generations in Families Talking Safe Sleep
A study testing Safety Baby shower in people with Sudden Infant Death, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant mortality, in part because they may not be the sole decision-maker for an infant's sleep environment and position and they make seek advice from older female support people. Read more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sudden Infant Death
- What is being tested?
- Safety Baby shower
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2014to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- First child
- Live in Faulkner, Saline, White, Pulaski, Jefferson, Lonoke County
- 13-28 weeks pregnant
- Teen identified female support person age 30 or older
Who cannot join
- Non English speaking
- No support person identifiable
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Research institute
Little Rock, Arkansas, 72202
About this study
Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant mortality, in part because they may not be the sole decision-maker for an infant's sleep environment and position and they make seek advice from older female support people. Investigators will conduct a randomized controlled trial of a educational intervention to mitigate the risks of unsafe infant sleep practices across generations. Given the complexity and variability of teen-SCG relationships, investigators will include an examination of inter- and intra-personal factors that are key control variables or may mediate the uptake of safe sleep recommendations. Investigators believe that the intervention will empower support people to positively influence a teen mother's adoption of safe sleep recommendations.
Read the detailed description
The infant mortality rate in the United States (US) is 6.14 per 1000-a rate higher than most other developed countries. Sudden Infant Death Syndrome (SIDS) and suffocation account for more than half of all Sudden Unexpected Infant Deaths (SUID) and represent the first and third leading causes of post neonatal infant death (death in an infant age 28 days to 1 year) in the US. The importance of SIDS and SUID is reflected by strategic planning efforts conducted by the NICHD over the past two decades. Young, poor, unmarried, and minority women are at elevated risk for SIDS. Infants born to mothers aged 15 - 19 are at increased risk for infant mortality in general, with a rate of 9.59 per 1000 in 2008. National surveys including the National Infant Sleep Position Study and the Pregnancy Risk Assessment Monitoring System show that teen mothers are less likely to adhere to recommendations for supine sleeping, bed surfacing (including bed sharing on an adult bed) and other environmental precautions. Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant mortality, in part because they may not be the sole decision-maker for an infant's sleep environment and position. Teens often rely on their own mother or other senior caregivers (SCG) for information and assistance with child care. For the proposed study, SCG influence on a key set of parenting behaviors is especially salient. Several studies have demonstrated the important role of SCG on maternal behavior related to infant safety, breastfeeding, and sleep environment and practices. Attitudes about sleep position have been found to be more strongly associated with appropriate behaviors than knowledge. A mother's beliefs about choking risks have been found to be significant determinants of supine sleep positions, but those beliefs can be influenced by the source and dosage of advice. The infant's grandmother or other SCG can influence a mother's decision on sleep position. Other evidence indicates that the SCG to whom a teen mother may turn to for advice may also fail to adhere to recommendations for safe sleep. For this study investigators propose to build upon an existing, well-received Safety Baby Showers (SBS) educational program. The standardized intervention (which is currently utilized in 10 counties in Arkansas to educate pregnant mothers) uses engaging activities to educate participants on infant safety topics focused on motor vehicle safety, home safety, and safe sleep. The Central Hypotheses are as follows: H1) Teen mothers exposed to an intensive educational intervention will be more likely than controls to appropriately adopt safe sleep practices (supine position and in an appropriate sleep environment) with their infants, and H2) Because teen mothers will model their choice of infant sleep position and environment on behavior of their mothers or other significant female senior caregivers, they will be more likely to use those safe sleep practices when they and their mothers or other significant female senior caregivers also participate in tailored education about safe infant sleep. In order to accomplish the NIH funded research project investigators will proceed with three phases. Phase 1: Preparatory- Investigators will further refine the existing infant sleep safety intervention for pregnant teens and their mothers or other identified significant female SCGs and Phase 2: Pilot-Investigators will pilot the refined infant sleep intervention, recruitment strategies, and data collection methods and refine as needed based on pilot participant feedback. Phase 3: Full Launch- Investigators will conduct a randomized controlled trial to determine if the educational intervention both with and without SCGs is associated with an increase in both knowledge of appropriate safe sleep behaviors and in observed supine infant sleep positioning and appropriate sleep environment among teen mothers. Full Launch- Investigators will conduct a randomized controlled trial to determine if the educational intervention both with and without SCGs is associated with an increase in both knowledge of appropriate safe sleep behaviors and in observed supine infant sleep positioning and appropriate sleep environment among teen mothers
- Conditions
- Sudden Infant Death
- Being tested
- Safety Baby shower, Standard of Care
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Baby showerBehavioural
A Safety Baby Shower using didactic and experiential teaching methods to educate participants on safety topics focused on reducing infant mortality. Participants receive safety products as their "shower gifts" with education on appropriate use of the products. The relaxed setting also encourages participants to seek answers and clarify myths from credible sources not otherwise available among family and friends. For intervention provides information on the infant's sleep position, bedding, co-sleeping, and tobacco exposure, all of which, alone or in combination, are risk factors for sleep-related deaths in infants. Breastfeeding, a protective factor for SIDS, will be encouraged.
Standard of CareBehavioural
Participants will received standard of care in regards to infant injury prevention. Written material on car seat safety, prevention of abusive head trauma, and safe sleep environments will be provide to participants.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Safety Baby shower Teen Only | Active comparator | Only the teen will receive the educational intervention. Receives: Behavioral: Safety Baby shower |
| Behavioral: Safety Baby shower Dyad | Active comparator | Both the teen and the teens support person will receive the educational intervention. Receives: Behavioral: Safety Baby shower |
| Behavioral: Standard of Care Control | Other | Standard of care. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of safe sleep environment
comparison of safe vs unsafe sleep
Measured: 2-3 months post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start7 Oct 2014
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary E Aitken, MD, MPH, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186469
- Sponsor's protocol ID
- 203247
- Acronym
- GIFTSS
- Status last verified
- Jul 2019
- First submitted
- 12 Jun 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generations in Families Talking Safe Sleep
- ClinicalTrials.gov ID
- NCT03186469
- Acronym / sponsor ID
- GIFTSS / 203247
- Conditions
- Sudden Infant Death
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 7 Oct 2014 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 14 Jun 2017 (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.
Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant mortality, in part because they may not be the sole decision-maker for an infant's sleep environment and position and they make seek advice from older female support people. Investigators will conduct a randomized controlled trial of a educational intervention to mitigate the risks of unsafe infant sleep practices across generations. Given the complexity and variability of teen-SCG relationships, investigators will include an examination of inter- and intra-personal factors that are key control variables or may mediate the uptake of safe sleep recommendations. Investigators believe that the intervention will empower support people to positively influence a teen mother's adoption of safe sleep recommendations.
Detailed description
The infant mortality rate in the United States (US) is 6.14 per 1000-a rate higher than most other developed countries. Sudden Infant Death Syndrome (SIDS) and suffocation account for more than half of all Sudden Unexpected Infant Deaths (SUID) and represent the first and third leading causes of post neonatal infant death (death in an infant age 28 days to 1 year) in the US. The importance of SIDS and SUID is reflected by strategic planning efforts conducted by the NICHD over the past two decades. Young, poor, unmarried, and minority women are at elevated risk for SIDS. Infants born to mothers aged 15 - 19 are at increased risk for infant mortality in general, with a rate of 9.59 per 1000 in 2008. National surveys including the National Infant Sleep Position Study and the Pregnancy Risk Assessment Monitoring System show that teen mothers are less likely to adhere to recommendations for supine sleeping, bed surfacing (including bed sharing on an adult bed) and other environmental precautions. Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant mortality, in part because they may not be the sole decision-maker for an infant's sleep environment and position. Teens often rely on their own mother or other senior caregivers (SCG) for information and assistance with child care. For the proposed study, SCG influence on a key set of parenting behaviors is especially salient. Several studies have demonstrated the important role of SCG on maternal behavior related to infant safety, breastfeeding, and sleep environment and practices. Attitudes about sleep position have been found to be more strongly associated with appropriate behaviors than knowledge. A mother's beliefs about choking risks have been found to be significant determinants of supine sleep positions, but those beliefs can be influenced by the source and dosage of advice. The infant's grandmother or other SCG can influence a mother's decision on sleep position. Other evidence indicates that the SCG to whom a teen mother may turn to for advice may also fail to adhere to recommendations for safe sleep. For this study investigators propose to build upon an existing, well-received Safety Baby Showers (SBS) educational program. The standardized intervention (which is currently utilized in 10 counties in Arkansas to educate pregnant mothers) uses engaging activities to educate participants on infant safety topics focused on motor vehicle safety, home safety, and safe sleep. The Central Hypotheses are as follows: H1) Teen mothers exposed to an intensive educational intervention will be more likely than controls to appropriately adopt safe sleep practices (supine position and in an appropriate sleep environment) with their infants, and H2) Because teen mothers will model their choice of infant sleep position and environment on behavior of their mothers or other significant female senior caregivers, they will be more likely to use those safe sleep practices when they and their mothers or other significant female senior caregivers also participate in tailored education about safe infant sleep. In order to accomplish the NIH funded research project investigators will proceed with three phases. Phase 1: Preparatory- Investigators will further refine the existing infant sleep safety intervention for pregnant teens and their mothers or other identified significant female SCGs and Phase 2: Pilot-Investigators will pilot the refined infant sleep intervention, recruitment strategies, and data collection methods and refine as needed based on pilot participant feedback. Phase 3: Full Launch- Investigators will conduct a randomized controlled trial to determine if the educational intervention both with and without SCGs is associated with an increase in both knowledge of appropriate safe sleep behaviors and in observed supine infant sleep positioning and appropriate sleep environment among teen mothers. Full Launch- Investigators will conduct a randomized controlled trial to determine if the educational intervention both with and without SCGs is associated with an increase in both knowledge of appropriate safe sleep behaviors and in observed supine infant sleep positioning and appropriate sleep environment among teen mothers
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Safety Baby shower Teen Only | Active comparator | Behavioral: Safety Baby showerOnly the teen will receive the educational intervention. |
| Behavioral: Safety Baby shower Dyad | Active comparator | Behavioral: Safety Baby showerBoth the teen and the teens support person will receive the educational intervention. |
| Behavioral: Standard of Care Control | Other | Behavioral: Standard of CareStandard of care. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- First child
- Live in Faulkner, Saline, White, Pulaski, Jefferson, Lonoke County
- 13-28 weeks pregnant
- Teen identified female support person age 30 or older
Key exclusion criteria (2 listed)
- Non English speaking
- No support person identifiable
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 |
|---|---|---|
| Safety Baby showerA Safety Baby Shower using didactic and experiential teaching methods to educate participants on safety topics focused on reducing infant mortality. Participants receive safety products as their "shower gifts" with education on appropriate use of the products. The relaxed setting also encourages participants to seek answers and clarify myths from credible sources not otherwise available among family and friends. For intervention provides information on the infant's sleep position, bedding, co-sleeping, and tobacco exposure, all of which, alone or in combination, are risk factors for sleep-related deaths in infants. Breastfeeding, a protective factor for SIDS, will be encouraged. | Behavioural | Behavioral: Safety Baby shower Dyad, Behavioral: Safety Baby shower Teen Only |
| Standard of CareParticipants will received standard of care in regards to infant injury prevention. Written material on car seat safety, prevention of abusive head trauma, and safe sleep environments will be provide to participants. | Behavioural | Behavioral: Standard of Care Control |
Primary outcome
Use of safe sleep environment
Time frame: 2-3 months post delivery
comparison of safe vs unsafe sleep
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- 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. This study is not recruiting at the moment.
Mary E Aitken, MD, MPH principal investigator
Arkansas Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Baby shower in people with Sudden Infant Death, run by Arkansas Children's Hospital Research Institute 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of safe sleep environment (time frame: 2-3 months post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2019.