MedTrace Logo

Infant Care Practices Study

NCT03494621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2022-08-12

No results posted yet for this study

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?"

Conditions

  • Sudden Infant Death

Interventions

BEHAVIORAL

Protecting Babies While they Sleep Curriculum

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. .

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Avera McKennan Hospital & University Health Center

    lead OTHER

Principal Investigators

  • Amy Elliott, PhD · Avera Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2021-10-30
Completion
2022-05-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03494621 on ClinicalTrials.gov