Improving the Self-Efficacy of African American Parents in Infant Supine Sleep (PrAAIS)
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ClinicalTrials.gov Identifier: NCT01707173 |
Recruitment Status
:
Completed
First Posted
: October 16, 2012
Last Update Posted
: June 3, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
African American Infant Sleep Beliefs and Practices | Behavioral: Tailored education Behavioral: Standard Education | Not Applicable |
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 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |

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
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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
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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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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
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- 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 ]
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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,

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
United States, Michigan | |
Child Health Evaluation and Research Unit, University of Michigan | |
Ann Arbor, Michigan, United States, 48109-0456 |
Principal Investigator: | Kathryn L Moseley, MD, MPH | University of Michigan |
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 |