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

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kathryn Moseley, MD, MPH, University of Michigan
ClinicalTrials.gov Identifier:
NCT01707173
First received: October 11, 2012
Last updated: June 1, 2016
Last verified: June 2016

October 11, 2012
June 1, 2016
October 2012
April 2016   (final data collection date for 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 from infant ages 3 months to 6 months ] [ Designated as safety issue: No ]
  • 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 infant age 3 months to 6 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01707173 on ClinicalTrials.gov Archive Site
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Improving the Self-Efficacy of African American Parents in Infant Supine Sleep
Improving the Self-Efficacy of African American Parents in Infant Supine Sleep
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
African American Infant Sleep Beliefs and Practices
  • 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
  • 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
  • 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
    Intervention: Behavioral: Standard Education
  • 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.
    Intervention: Behavioral: Tailored education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
735
April 2016
April 2016   (final data collection date for primary outcome measure)

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,
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01707173
1R01HD064770-01A1, HUM00048679, R01HD064770
Yes
Not Provided
Not Provided
Kathryn Moseley, MD, MPH, University of Michigan
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
University of Michigan
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP