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

Not Applicable

Completed

• Conditions: African American Infant Sleep Beliefs and Practices
• Interventions: Behavioral: Standard Education; Behavioral: Tailored education

• Registration Number: NCT01707173
• Lead Sponsor: University of Michigan

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 735

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.

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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,

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Education	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
Tailored education	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.

Primary Outcome Measures

Name	Time	Method
Infants position for last night's sleep per parental report	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
Infant's usual sleep position per parental report	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

Trial Locations

Locations (1)

Child Health Evaluation and Research Unit, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States