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Comparing Children's Book to Brochures for Safe Sleep Education in a Home Visiting Program

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ClinicalTrials.gov Identifier: NCT02376673
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : February 2, 2017
Sponsor:
Collaborators:
de Cavel Family SIDS Foundation
Every Child Succeeds
Information provided by (Responsible Party):
Dr. John Hutton, MD FAAP, Children's Hospital Medical Center, Cincinnati

Brief Summary:
This randomized controlled trial compares a specially-designed children's book to standard brochures for safe sleep education and reduction of Sudden Infant Death Syndrome (SIDS) risk in a high-risk population of young, first-time mothers enrolled in a home visitation program. Roughly half of the mothers will receive safe sleep education via the book, the other half via brochures, during prescribed home visits. Our study will assess differences in safe sleep knowledge, adherence to recommendations, satisfaction with materials used, and attitudes towards reading with their baby. Our hypothesis is that these will be higher in the group receiving the book, due to simpler language, appealing illustrations, emotional connection, and repeated exposures via shared reading.

Condition or disease Intervention/treatment Phase
Sudden Infant Death Syndrome (SIDS) Other: Children's Book Other: Standard Brochures Not Applicable

Detailed Description:

Safe sleep and health literacy are priorities at national, state, and local levels. While greatly improved since the launch of the Back to Sleep campaign in the 1990s, the rate of sleep-related infant deaths, notably Sudden Infant Death Syndrome (SIDS), has been stagnant for over a decade. While printed materials are widely distributed for SIDS education, to date none have been proven effective, and overall satisfaction has been low. Reasons include passive delivery, unappealing content, and excessively high reading level, especially for low-socioeconomic status populations. Evidence suggests that an ideal strategy involves printed materials combining simplicity, emotional appeal, cultural sensitivity, and low reading level, conveyed by health care practitioners and reviewed multiple times. Children's books are a potentially ideal medium for this, combining pictures and text to invoke emotion and inspire a shared parent-child experience that is valued and repeated.

This is a randomized controlled trial involving a population of at-risk, low-socioeconomic status, first-time mothers enrolled in an early intervention home visitation program, Every Child Succeeds (ECS). ECS home visitors from 9 agencies will be randomly assigned to utilize either a specially-designed children's book (intervention) or standard brochures (control) for safe sleep education. Our target enrollment is 230 mothers. Trained ECS home visitors will obtain consent, distribute the book or brochures, and perform baseline assessment of health literacy (via the REALM-R screen), safe sleep knowledge, and home literacy orientation during a third trimester, prenatal home visit. Outcomes data will be collected by the same visitor during subsequent home visits at 1 week old, when infant sleep routines are being established, and 2 months old, at onset of peak SIDS risk. At each visit, the book or brochures will be reviewed.

Outcomes will be compared between intervention and control groups in the following categories: 1) maternal safe sleep knowledge, 2) maternal adherence to safe sleep guidelines (observed), 3) maternal and provider satisfaction with materials utilized to convey safe sleep guidelines, and 4) the degree to which utilizing a children's book for health education impacts home literacy orientation (i.e. attitudes towards reading).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Comparing a Children's Book to Brochures for Safe Sleep Education in an At-Risk Population Enrolled in a Home Visitation Program
Actual Study Start Date : June 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Brochures
Mothers in this arm will receive safe sleep education from home visitors using standard brochures (including 1-page handouts and pamphlets) that are customarily used in this home visiting program.
Other: Standard Brochures
An assortment of standard safe sleep educational brochures provided by home visitors during prescribed home visits, covering various recommendations for safe sleep.
Other Names:
  • What does a safe sleep environment look like?
  • Bright Futures - Newborn Visit
  • Home Safe Home - Sleep
  • Helping Baby Back to Sleep
  • Sleep and your 1-3 month-old

Experimental: Children's Book
Mothers in this arm will receive safe sleep education from home visitors using a specially-designed children's book incorporating American Academy of Pediatrics safe sleep guidelines.
Other: Children's Book
A specially-designed, illustrated (full color) children's book written at a first-grade level, conveying American Academy of Pediatrics safe sleep guidelines through the story. Expanded guidelines are listed on the back cover, at a 4th grade reading level. This book will be exclusively used for safe sleep education at 3 study home visits: prenatal between 32 weeks and term, 1 week postnatal, and 2 months postnatal. The mother will be encouraged to share the book with her baby.
Other Name: Sleep Baby, Safe and Snug




Primary Outcome Measures :
  1. Change In Maternal Safe Sleep Knowledge [ Time Frame: Prenatal baseline to 1 week and 2 months postnatally ]
    Change in maternal knowledge of safe sleep recommendations (per American Academy of Pediatrics) from a baseline collected prenatally, to outcomes measured at approximately 1 week and then 2 months postnatally.

  2. Assessment of Infant Sleep Environment [ Time Frame: During study home visits 1 week and 2 months postnatally ]
    Direct assessment in the home of infant sleep environment and maternal adherence to American Academy of Pediatrics safe sleep recommendations via the home visitor at approximately 1 week and then 2 months postnatally

  3. Maternal Impression of Safe Sleep Materials Provided [ Time Frame: At study home visits 1 week and 2 months postnatally ]
    Maternal impression of printed materials (book or brochures) used for safe sleep teaching, content and usefulness.

  4. Home Visitor Impression of Safe Sleep Materials Provided [ Time Frame: At each study home visit: prenatal, 1 week, and 2 months postnatally ]
    Home visitor impression of printed materials (book or brochures) used for safe sleep teaching, time of delivery and usefulness.


Secondary Outcome Measures :
  1. Maternal Health Literacy Screen [ Time Frame: One time prenatally ]
    Maternal health literacy screen using the validated REALM-R measure (recognizing and pronouncing medical words)

  2. Change in Home Literacy Orientation [ Time Frame: Baseline prenatally and 2 months postnatally ]
    Change is assessed via six questions concerning planned or current shared reading frequency, children's books in the home, and attitudes towards shared reading, as well as attitudes towards and frequency of television use.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prenatal enrollment in the Every Child Succeeds home visitation program,
  • English speaking (intervention book was not available in Spanish), and
  • at least 15 years old.

Exclusion Criteria:

  • Non-English speaking,
  • age under 15 years,
  • delayed hospital discharge such that an initial postnatal home visit prior to 3 weeks old is not possible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376673


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
de Cavel Family SIDS Foundation
Every Child Succeeds
Publications:
Murphy, S., Xu, J., & Kochanek, K. (2013). National Vital Statistics Report. Deaths: Final Data for 2010. Washington, DC.
Wymyslo T, Director. Ohio Child Fatality Review Twelfth Annual Report: 2006-2010, 2012.
Maseru, N. P. D., MPH. (2011). Cincinnati-Hamilton County Fetal-Infant Mortality Review. Cincinnat, OH.
NICHD. Safe to Sleep Campaign. 1994-present.; http://www.nichd.nih.gov/sts/Pages/default.aspx.
National Institutes of Health. Clear Communication: A NIH Health Literacy Initiative. 2013; http://www.nih.gov/clearcommunication/healthliteracy.
Rankin SH, Stallings KD. Patient Education: Principles and Practices. 4th ed. Philadelphia: Lippincott WIlliams and Wilkins; 2001.
Surber J. Effect of topic label repetition and importance on reading time and recall of text. J Educ Psychology. 2001;93(2):279-287.
Nyhout A, O'Neill D. Mothers' complex talk when sharing books with their toddlers: book genre matters. First Language. 2013;33(2):115-131.
Every Child Succeeds. 2013; http://www.everychildsucceeds.org/Our-Mission.aspx.
Hutton JS, Busch L. Sleep Baby, Safe and Snug. Cincinnati, OH: blue manatee press; 2013.
Whitehurst GJ. Dialogic Reading: An Effective Way to Read to Preschoolers. 2013; http://www.readingrockets.org/article/400/.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. John Hutton, MD FAAP, Clinical Research Fellow, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02376673    
Other Study ID Numbers: CincinnatiChildrens
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Keywords provided by Dr. John Hutton, MD FAAP, Children's Hospital Medical Center, Cincinnati:
Pediatric Health Literacy
Home Literacy Orientation
safe sleep
Additional relevant MeSH terms:
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Infant Death
Sudden Infant Death
Death
Pathologic Processes
Death, Sudden