Infant Care Practices Study
Condition: Sudden Infant Death
MeSH terms: Infant Death; Sudden Infant Death
Study type: Interventional

Summary: 
      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?"
    

Detailed description: 
      The proposed study is a two-group randomized trial with a total sample size of 150. Pregnant
      women from Western South Dakota who meet eligibility criteria will be randomly assigned to an
      intervention or a control group and will be followed through their pregnancy and postnatal
      period until their infant reaches one year of age. They will remain in their randomized group
      throughout the course of the study.

      Intervention group: Participants randomly assigned to the intervention group will have three
      prenatal contacts at study site offices. These contacts will include collection of covariate
      data, engagement with the Protecting Babies While They Sleep curriculum and activities
      (described below) led by trained study staff, and assessment of the overall session quality
      and acceptability. Participants will be allowed to invite up to two family members or other
      support persons to attend the third prenatal contact. The research coordinator will review
      the consent form and request consent for each guest of the participant. Guests will be asked
      to provide a subset of the covariate data provided by the primary participant, engage with
      the curriculum and associated activities, and assess the overall session quality and
      acceptability.

      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 study investigators
      worked with a Community Advisory Board (CAB) to design the focus group and interview
      questions, interpret the resulting qualitative data, and guide development of the
      intervention curriculum. The curriculum combines culturally-based prenatal and infant care
      education with current safe sleep recommendations from the American Academy of Pediatrics
      (AAP). The main components include: brief videos featuring medical professionals and American
      Indian elders, discussion guided by Motivational Interviewing principles, and
      culturally-based activities designed to reinforce the curriculum objectives.
    

Intervention name(s): Protecting Babies While they Sleep Curriculum
Intervention type(s): Behavioral
Intervention description(s): 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. .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention