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Infant Care Practices Study (ICP)

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ClinicalTrials.gov Identifier: NCT03494621
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

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?"

Condition or disease Intervention/treatment Phase
Sudden Infant Death Behavioral: Protecting Babies While they Sleep Curriculum Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A CBPR Initiative for Reducing Infant Mortality In American Indian Communities
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
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
Experimental: Protecting Babies While They Sleep
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
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. .




Primary Outcome Measures :
  1. Implementation of safe sleeping practices [ Time Frame: Three months ]
    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.


Secondary Outcome Measures :
  1. Change in Safe Sleep knowledge [ Time Frame: prenatal, 3 months postnatal, 6 months postnatal, 1 year ]
    The impact of the intervention on the participant's knowledge of safe sleep will be assessed through participant self report.

  2. Change in beliefs regarding infant safe sleep [ Time Frame: prenatal, 3 months postnatal, 6 months postnatal, 1 year ]
    The impact of the intervention on the participants' belief regarding infant safe sleep will be measured through self report

  3. Change in safe sleep practice [ Time Frame: prenatal, 3 months postnatal, 6 months postnatal, 1 year ]
    The impact of the intervention on the participants' practice of safe sleep will be measured through self report



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Self-identified as American Indian
  2. Able to provide informed consent or assent
  3. Mother's age 14 years or older
  4. If emancipated minor, not living in group home or care facility
  5. Gestational age 20 weeks or less
  6. No planned relocation outside the catchment area
  7. Fluency in English

Exclusion Criteria:

  1. Not self-identified as American Indian
  2. Unable to provide informed consent or assent
  3. Mother's age less than 14 years
  4. Emancipated minor living in group home or care facility
  5. Gestational age more than 20 weeks
  6. Planned relocation outside of the catchment area
  7. Not fluent in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494621


Contacts
Contact: Jyoti Angal, MPH 605-504-3153 jyoti.angal@avera.org

Locations
United States, South Dakota
Avera Research Institute Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Jyoti Angal, MPH    605-504-3153      
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Amy Elliott, PhD Avera Research Institute

Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT03494621     History of Changes
Other Study ID Numbers: 2017088
R01HD080544-01 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators understand that sharing of research data with the broad research community promotes collaboration and further development of the scientific field. The investigators intend to share de-identified data with NIH in accordance with tribal policies and regulations. The investigators anticipate that a detailed plan will be in place to allow for sharing of data after analysis and publication of the primary hypothesis.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infant Death
Sudden Infant Death
Death
Pathologic Processes
Death, Sudden