Infant Care Practices Study (ICP)
Sudden Infant Death
About this trial
This is an interventional prevention trial for Sudden Infant Death
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Avera Research Institute
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control group
Protecting Babies While They Sleep
Participants randomly assigned to the control group will have three prenatal contacts at the same gestational ages as the intervention participants. These contacts will include collection of covariate data, review of locally available educational materials on pregnancy/infant care led by trained study staff, and assessment of the overall session quality and acceptability. The educational materials provided during these sessions are drawn from materials currently available at local health care facilities
The intervention curriculum derives from information gathered at previously conducted focus groups and interviews, which aimed to ascertain the role of caregiver knowledge, beliefs, and access to resources in implementation of infant safe sleep practices. The protocol for the focus groups and interviews has been reviewed by the Tribal Institutional Review Board. The focus groups were conducted in Rapid City and a western Tribal reservation with pregnant adult women and pregnant, parenting, or other interested adolescent women; fathers (adult men); and elder women. Two focus groups were held for each category of individuals. Additional qualitative data was collected via key informant interviews with individuals vested and experienced in maternal and child health.