- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01707173
Improving the Self-Efficacy of African American Parents in Infant Supine Sleep (PrAAIS)
June 1, 2016 updated by: Kathryn Moseley, MD, MPH, University of Michigan
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 Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
735
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
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Ann Arbor, Michigan, United States, 48109-0456
- Child Health Evaluation and Research Unit, University of Michigan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
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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
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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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
|
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
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathryn L Moseley, MD, MPH, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
October 11, 2012
First Submitted That Met QC Criteria
October 15, 2012
First Posted (Estimate)
October 16, 2012
Study Record Updates
Last Update Posted (Estimate)
June 3, 2016
Last Update Submitted That Met QC Criteria
June 1, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R01HD064770-01A1 (U.S. NIH Grant/Contract)
- HUM00048679 (Other Identifier: University of Michigan)
- R01HD064770 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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