Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT03186469
Status:
UNKNOWN
Last Update Posted:
2019-07-18
First Post:
2017-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Generations in Families Talking Safe Sleep
Sponsor:
Arkansas Children's Hospital Research Institute
Organization:
Study Overview
Official Title:
Generations in Families Talking Safe Sleep
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GIFTSS
Brief 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. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: