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

NCT ID: NCT01707173

Last Updated: 2016-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

735 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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African American Infant Sleep Beliefs and Practices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Standard Education

Intervention Type 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

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.

Group Type EXPERIMENTAL

Tailored education

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Kathryn Moseley, MD, MPH

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathryn L Moseley, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Child Health Evaluation and Research Unit, University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00048679

Identifier Type: OTHER

Identifier Source: secondary_id

R01HD064770

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01HD064770-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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