Generations in Families Talking Safe Sleep
GIFTSS
1 other identifier
interventional
146
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 7, 2014
CompletedFirst Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedJuly 18, 2019
July 1, 2019
5.6 years
June 12, 2017
July 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Use of safe sleep environment
comparison of safe vs unsafe sleep
2-3 months post delivery
Study Arms (3)
Behavioral: Safety Baby shower Teen Only
ACTIVE COMPARATOROnly the teen will receive the educational intervention.
Behavioral: Safety Baby shower Dyad
ACTIVE COMPARATORBoth the teen and the teens support person will receive the educational intervention.
Behavioral: Standard of Care Control
OTHERStandard of care.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- First child
- Live in Faulkner, Saline, White, Pulaski, Jefferson, Lonoke County
- weeks pregnant
- Teen identified female support person age 30 or older
You may not qualify if:
- Non English speaking
- No support person identifiable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arkansas Children's Research institute
Little Rock, Arkansas, 72202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary E Aitken, MD, MPH
Arkansas Children's Hospital Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Data collector will be blinded as to which arm study participants are enrolled
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2017
First Posted
June 14, 2017
Study Start
October 7, 2014
Primary Completion
April 30, 2020
Study Completion
October 31, 2020
Last Updated
July 18, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share