Generations in Families Talking Safe Sleep (GIFTSS)
Primary Purpose
Sudden Infant Death
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Baby shower
Standard of Care
Sponsored by
About this trial
This is an interventional prevention trial for Sudden Infant Death
Eligibility Criteria
Inclusion Criteria:
- First child
- Live in Faulkner, Saline, White, Pulaski, Jefferson, Lonoke County
- 13-28 weeks pregnant
- Teen identified female support person age 30 or older
Exclusion Criteria:
- Non English speaking
- No support person identifiable
Sites / Locations
- Arkansas Children's Research institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Behavioral: Safety Baby shower Teen Only
Behavioral: Safety Baby shower Dyad
Behavioral: Standard of Care Control
Arm Description
Only the teen will receive the educational intervention.
Both the teen and the teens support person will receive the educational intervention.
Standard of care.
Outcomes
Primary Outcome Measures
Use of safe sleep environment
comparison of safe vs unsafe sleep
Secondary Outcome Measures
Full Information
NCT ID
NCT03186469
First Posted
June 12, 2017
Last Updated
July 16, 2019
Sponsor
Arkansas Children's Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03186469
Brief Title
Generations in Families Talking Safe Sleep
Acronym
GIFTSS
Official Title
Generations in Families Talking Safe Sleep
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 7, 2014 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Infant Death
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
Data collector will be blinded as to which arm study participants are enrolled
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral: Safety Baby shower Teen Only
Arm Type
Active Comparator
Arm Description
Only the teen will receive the educational intervention.
Arm Title
Behavioral: Safety Baby shower Dyad
Arm Type
Active Comparator
Arm Description
Both the teen and the teens support person will receive the educational intervention.
Arm Title
Behavioral: Standard of Care Control
Arm Type
Other
Arm Description
Standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Safety Baby shower
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Use of safe sleep environment
Description
comparison of safe vs unsafe sleep
Time Frame
2-3 months post delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
First child
Live in Faulkner, Saline, White, Pulaski, Jefferson, Lonoke County
13-28 weeks pregnant
Teen identified female support person age 30 or older
Exclusion Criteria:
Non English speaking
No support person identifiable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E Aitken, MD, MPH
Organizational Affiliation
Arkansas Children's Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Research institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Generations in Families Talking Safe Sleep
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