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

NCT01707173 | Completed DMC

• 3 other identifiers: 1R01HD064770-01A1HUM00048679R01HD064770
• Study Type: interventional
• Target: 735
• Locations: 1 country
• Sites: 1

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.

Conditions

African American Infant Sleep Beliefs and Practices

Keywords

SIDS

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Standard Education

OTHER

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

Tailored education

EXPERIMENTAL

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

Interventions

Tailored education BEHAVIORAL

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

Tailored education

Standard Education BEHAVIORAL

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

Standard Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Child Health Evaluation and Research Unit, University of Michigan

Ann Arbor, Michigan, 48109-0456, United States

Location

MeSH Terms

Conditions

Sudden Infant Death

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death

Study Officials

• Kathryn L Moseley, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 3, 2016

Record last verified: 2016-06

Locations

US (1)