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Completed

NCT Number: NCT01707173

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

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.

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Key information

Conditions

African American Infant Sleep Beliefs and Practices Death Death, Sudden Infant Death Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Infant Death

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child Health Evaluation and Research Unit, University of Michigan

Ann Arbor, Michigan, 48109-0456, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: PrAAIS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 16, 2012
Registry last updated
Jun 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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