- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03494621
Infant Care Practices Study (ICP)
A CBPR Initiative for Reducing Infant Mortality In American Indian Communities
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Avera Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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
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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.
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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. .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implementation of safe sleeping practices
Time Frame: Three months
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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.
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Three months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Safe Sleep knowledge
Time Frame: prenatal, 3 months postnatal, 6 months postnatal, 1 year
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The impact of the intervention on the participant's knowledge of safe sleep will be assessed through participant self report.
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prenatal, 3 months postnatal, 6 months postnatal, 1 year
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Change in beliefs regarding infant safe sleep
Time Frame: prenatal, 3 months postnatal, 6 months postnatal, 1 year
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The impact of the intervention on the participants' belief regarding infant safe sleep will be measured through self report
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prenatal, 3 months postnatal, 6 months postnatal, 1 year
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Change in safe sleep practice
Time Frame: prenatal, 3 months postnatal, 6 months postnatal, 1 year
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The impact of the intervention on the participants' practice of safe sleep will be measured through self report
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prenatal, 3 months postnatal, 6 months postnatal, 1 year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amy Elliott, PhD, Avera Research Institute
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017088
- R01HD080544-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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