Infant Care Practices Study

NCT03494621 | Completed

• 2 other identifiers: 2017088R01HD080544-01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Implementation of safe sleeping practices

  Primary outcome will be measured by participant report about infant sleep location and sleep position. Infant location is considered safe if participant reports a 'no' response to if the participant shared a sleep location with baby. INfant sleep position is considered safe if the participant provides a 'yes' response to whether the baby was put on its back to sleep for every sleep. The two responses will be aggregated together to derive that the participant is practicing safe sleep habits.If either question indicates unsafe sleeping habits, the participant will be counted as not practicing safe sleeping habits.

  Three months

Secondary Outcomes (3)

• Change in Safe Sleep knowledge

  prenatal, 3 months postnatal, 6 months postnatal, 1 year

• Change in beliefs regarding infant safe sleep

  prenatal, 3 months postnatal, 6 months postnatal, 1 year

• Change in safe sleep practice

  prenatal, 3 months postnatal, 6 months postnatal, 1 year

Study Arms (2)

Control group

NO INTERVENTION

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

Protecting Babies While They Sleep

EXPERIMENTAL

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.

Behavioral: Protecting Babies While they Sleep Curriculum

Interventions

Protecting Babies While they Sleep Curriculum BEHAVIORAL

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. .

Protecting Babies While They Sleep

Eligibility Criteria

• Age: 14 Years - 49 Years
• Gender Eligibility Details: Yes
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Avera McKennan Hospital & University Health Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Avera Research Institute

Rapid City, South Dakota, 57701, United States

Location

MeSH Terms

Conditions

Sudden Infant Death

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death

Study Officials

• Amy Elliott, PhD

  Avera Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 11, 2018
• Study Start: March 28, 2018
• Primary Completion: October 30, 2021
• Study Completion: May 30, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

US (1)