Improving the Self-Efficacy of African American Parents in Infant Supine Sleep (PrAAIS)
This study has been completed.
Sponsor:
University of Michigan
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kathryn Moseley, MD, MPH, University of Michigan
ClinicalTrials.gov Identifier:
NCT01707173
First received: October 11, 2012
Last updated: June 1, 2016
Last verified: June 2016
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Purpose
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 | Intervention |
|---|---|
|
African American Infant Sleep Beliefs and Practices |
Behavioral: Tailored education Behavioral: Standard Education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Improving the Self-Efficacy of African American Parents in Infant Supine Sleep |
Resource links provided by NLM:
Further study details as provided by University of Michigan:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 735 |
| Study Start Date: | October 2012 |
| Study Completion Date: | April 2016 |
| Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707173
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707173
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
| Responsible Party: | Kathryn Moseley, MD, MPH, Assistant Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01707173 History of Changes |
| Other Study ID Numbers: | 1R01HD064770-01A1 HUM00048679 R01HD064770 |
| Study First Received: | October 11, 2012 |
| Last Updated: | June 1, 2016 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of Michigan:
|
SIDS |
ClinicalTrials.gov processed this record on September 26, 2016