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

This study is ongoing, but not recruiting participants.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Dr. Kathryn Moseley, University of Michigan Identifier:
First received: October 11, 2012
Last updated: January 26, 2016
Last verified: January 2016
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.

Condition Intervention
African American Infant Sleep Beliefs and Practices
Behavioral: Tailored education
Behavioral: Standard Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Improving the Self-Efficacy of African American Parents in Infant Supine Sleep

Further study details as provided by University of Michigan:

Enrollment: 735
Study Start Date: October 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard Education
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
Behavioral: Standard Education
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
Experimental: Tailored education
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.
Behavioral: Tailored education
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

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01707173

United States, Michigan
Child Health Evaluation and Research Unit, University of Michigan
Ann Arbor, Michigan, United States, 48109-0456
Sponsors and Collaborators
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Kathryn L Moseley, MD, MPH University of Michigan
  More Information

Responsible Party: Dr. Kathryn Moseley, Assistant Professor, University of Michigan Identifier: NCT01707173     History of Changes
Other Study ID Numbers: 1 RO1 HD064770-01A1  HUM00048679  R01HD064770 
Study First Received: October 11, 2012
Last Updated: January 26, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Michigan:
SIDS processed this record on May 04, 2016