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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Phase
African American Infant Sleep Beliefs and Practices	Behavioral: Tailored education; Behavioral: Standard Education	Not Applicable

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
Last Update Posted:	June 3, 2016
Last Verified:	June 2016

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

SIDS