Infant Care Practices Study
Completed · Not applicable
Conditions studied: Sudden Infant Death
In brief
This proposed project will engage American Indian communities through existing partnerships, utilizing a Community Based Participatory Research (CBPR) methodology to design a group intervention program to increase the safety of infant sleep environments. Compelling evidence from research in other racial populations suggests that family and cultural norms, attitudes and personal beliefs about infant sleep, safety and comfort are strongly associated with the choice of infant sleep environment. It may be possible that the current safe sleep messages are in conflict with inherent cultural beliefs within these communities. This conflict with the scientific recommendations regarding safe sleep may influence behavior, even in the presence of adequate knowledge about safe sleep practices. Preliminary discussions with many tribal leaders and elders suggest that this chasm between culture and scientific recommendations can be bridged with an intervention incorporating culture, education and resources. However, there is limited research on factors influencing infant safe sleep practices of American Indian mothers. This study will test the effectiveness of incorporating cultural beliefs and practices into an intervention package based on the American Academy of Pediatrics safe sleep guidelines that incorporates both education and provision of resources. Therefore, the research question is: "Does a culturally specific safe sleep intervention, developed using CBPR, reduce the risk of unsafe infant sleep practices in Northern Plains American Indian communities?"
Key facts
- Study ID
- NCT03494621
- Run by
- Avera McKennan Hospital & University Health Center
- People needed
- 115
- Starts
- 2018-03-28
- Expected to finish
- 2022-05-30
- Last updated by the study team
- 2022-08-12
Who can join
Age: 14 and older, up to 49. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Self-identified as American Indian
- Able to provide informed consent or assent
- Mother's age 14 years or older
- If emancipated minor, not living in group home or care facility
- Gestational age 20 weeks or less
- No planned relocation outside the catchment area
- Fluency in English
You may not qualify if…
- Not self-identified as American Indian
- Unable to provide informed consent or assent
- Mother's age less than 14 years
- Emancipated minor living in group home or care facility
- Gestational age more than 20 weeks
- Planned relocation outside of the catchment area
- Not fluent in English
Where it is running
- Avera Research Institute — Rapid City, South Dakota, United States
Full record on ClinicalTrials.gov
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