Infant Care Practices Study (ICP)
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|ClinicalTrials.gov Identifier: NCT03494621|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sudden Infant Death||Behavioral: Protecting Babies While they Sleep Curriculum||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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. .
- 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.
- 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.
- 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
- 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
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
|Contact: Jyoti Angal, MPHemail@example.com|
|United States, South Dakota|
|Avera Research Institute||Recruiting|
|Rapid City, South Dakota, United States, 57701|
|Contact: Jyoti Angal, MPH 605-504-3153|
|Principal Investigator:||Amy Elliott, PhD||Avera Research Institute|