Ann Arbor, Michigan 48109

  • African American Infant Sleep Beliefs and Practices

Purpose:

This is a research study of African American parents/caregivers of newborns. The purpose of this research study is to learn what type of educational materials about infant safety and safe infant sleep are most effective and acceptable to parents and caregivers. The investigators will compare the responses of parents who receive enhanced materials to the responses of parents who receive the ordinary materials that are currently in use.


Study summary:

The goal of the proposed research is to determine whether a tailored multi-media mailed intervention is superior to standard non-tailored print brochures along with a generic DVD in increasing the prevalence of African American infant supine sleep during the first six months of life.


Criteria:

Inclusion Criteria:- - Self-identified AA adult parents and primary caregivers (≥ 18 years of age) of newborns ≤ four weeks old at the time of the infant's first office visit to the pediatrician. Exclusion Criteria: - Foster parents and temporary guardians: - Prior study participants: - Parents without a reliable phone number: - Parents without ready access to a DVD player: an ownership of a DVD player,


Study is Available At:


Original ID:

1 RO1 HD064770-01A1


NCT ID:

NCT01707173


Secondary ID:

HUM00048679


Study Acronym:

PrAAIS


Brief Title:

Improving the Self-Efficacy of African American Parents in Infant Supine Sleep


Official Title:

Improving the Self-Efficacy of African American Parents in Infant Supine Sleep


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Parall


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

735


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kathryn L Moseley, MD, MPH
Principal Investigator
University of Michigan

Study Dates

Start Date:October 2012
Completion Date:April 2016
Completion Type:Actual
Primary Completion Date:April 2016
Primary Completion Type:Actual
Verification Date:June 2016
Last Changed Date:June 1, 2016
First Received Date:October 11, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Infant's usual sleep position per parental report
Time Frame:Change in position from study entry to infant ages 3 months and to six months; change in position fr
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Infants position for last night's sleep per parental report
Time Frame:Change in position from study entry to infant ages 3 months and six months; change in position from
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Standard Education
Description:Participants will receive currently available publications about infant sleep from the American Academy of Pediatrics and the AAP at 2 separate times over a 6 month period along with a generic DVD about infant safety practices
Arm Name:Standard Education
Intervention Type:Behavioral
Name:Tailored education
Description:Using information gleaned from interviews, educational print materials tailored to the participant's beliefs about infant safe sleep practices, will be mailed to the participants home at 2 separate times over a 6 month period along with a culturally relevant DVD with safe sleep information
Arm Name:Tailored education

Study Arms

Study Arm Type:Experimental
Arm Name:Tailored education
Description:Parents/caregivers will receive educational materials tailored to their specific beliefs and barriers about infant supine sleep along with a DVD detailing standard guidelines along with specific solutions and facilitators to infant supine sleep as the intervention.
Study Arm Type:Other
Arm Name:Standard Education
Description:Control group participants will receive standard educational materials published by the CDC or American Academy of Pediatrics as an intervention along with a generic infant safety DVD

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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