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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01707173
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
African American Infant Sleep Beliefs and Practices Behavioral: Tailored education Behavioral: Standard Education

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 735 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Improving the Self-Efficacy of African American Parents in Infant Supine Sleep
Study Start Date : October 2012
Primary Completion Date : April 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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,
Contacts and Locations

Information from the National Library of Medicine

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): NCT01707173


Locations
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)
Investigators
Principal Investigator: Kathryn L Moseley, MD, MPH University of Michigan
More Information

Responsible Party: Kathryn Moseley, MD, MPH, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01707173     History of Changes
Other Study ID Numbers: 1R01HD064770-01A1 ( U.S. NIH Grant/Contract )
HUM00048679 ( Other Identifier: University of Michigan )
R01HD064770 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016

Keywords provided by Kathryn Moseley, MD, MPH, University of Michigan:
SIDS