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

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

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.

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).

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.

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.

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.

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

An assortment of standard safe sleep educational brochures provided by home visitors during prescribed home visits, covering various recommendations for safe sleep.

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.

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

Maternal impression of printed materials (book or brochures) used for safe sleep teaching, content and usefulness.

Home visitor impression of printed materials (book or brochures) used for safe sleep teaching, time of delivery and usefulness.

Maternal health literacy screen using the validated REALM-R measure (recognizing and pronouncing medical words)

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.

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.

Moon RY, Fu L. Sudden infant death syndrome: an update. Pediatr Rev. 2012 Jul;33(7):314-20. doi: 10.1542/pir.33-7-314.

Reich SM, Penner EK, Duncan GJ. Using baby books to increase new mothers' safety practices. Acad Pediatr. 2011 Jan-Feb;11(1):34-43. doi: 10.1016/j.acap.2010.12.006.

Zuckerman B, Khandekar A. Reach Out and Read: evidence based approach to promoting early child development. Curr Opin Pediatr. 2010 Aug;22(4):539-44. doi: 10.1097/MOP.0b013e32833a4673.

Vennemann MM, Hense HW, Bajanowski T, Blair PS, Complojer C, Moon RY, Kiechl-Kohlendorfer U. Bed sharing and the risk of sudden infant death syndrome: can we resolve the debate? J Pediatr. 2012 Jan;160(1):44-8.e2. doi: 10.1016/j.jpeds.2011.06.052. Epub 2011 Aug 24.

Murphy SL, Xu J, Kochanek KD. Deaths: final data for 2010. Natl Vital Stat Rep. 2013 May 8;61(4):1-117.

Maseru, N. P. D., MPH. (2011). Cincinnati-Hamilton County Fetal-Infant Mortality Review. Cincinnat, OH.

MacDorman MF, Cnattingius S, Hoffman HJ, Kramer MS, Haglund B. Sudden infant death syndrome and smoking in the United States and Sweden. Am J Epidemiol. 1997 Aug 1;146(3):249-57. doi: 10.1093/oxfordjournals.aje.a009260.

Hauck FR, Thompson JM, Tanabe KO, Moon RY, Vennemann MM. Breastfeeding and reduced risk of sudden infant death syndrome: a meta-analysis. Pediatrics. 2011 Jul;128(1):103-10. doi: 10.1542/peds.2010-3000. Epub 2011 Jun 13.

Moon RY, Tanabe KO, Yang DC, Young HA, Hauck FR. Pacifier use and SIDS: evidence for a consistently reduced risk. Matern Child Health J. 2012 Apr;16(3):609-14. doi: 10.1007/s10995-011-0793-x.

Moon RY, Oden RP, Grady KC. Back to Sleep: an educational intervention with women, infants, and children program clients. Pediatrics. 2004 Mar;113(3 Pt 1):542-7. doi: 10.1542/peds.113.3.542.

Fu LY, Colson ER, Corwin MJ, Moon RY. Infant sleep location: associated maternal and infant characteristics with sudden infant death syndrome prevention recommendations. J Pediatr. 2008 Oct;153(4):503-8. doi: 10.1016/j.jpeds.2008.05.004. Epub 2008 Jun 25.

Robida D, Moon RY. Factors influencing infant sleep position: decisions do not differ by SES in African-American families. Arch Dis Child. 2012 Oct;97(10):900-5. doi: 10.1136/archdischild-2011-301360. Epub 2012 Aug 17.

Ottolini MC, Davis BE, Patel K, Sachs HC, Gershon NB, Moon RY. Prone infant sleeping despite the "Back to Sleep" campaign. Arch Pediatr Adolesc Med. 1999 May;153(5):512-7. doi: 10.1001/archpedi.153.5.512.

Cowan S, Pease A, Bennett S. Usage and impact of an online education tool for preventing sudden unexpected death in infancy. J Paediatr Child Health. 2013 Mar;49(3):228-32. doi: 10.1111/jpc.12128. Epub 2013 Feb 26.

Moult B, Franck LS, Brady H. Ensuring quality information for patients: development and preliminary validation of a new instrument to improve the quality of written health care information. Health Expect. 2004 Jun;7(2):165-75. doi: 10.1111/j.1369-7625.2004.00273.x.

Glascoe FP, Oberklaid F, Dworkin PH, Trimm F. Brief approaches to educating patients and parents in primary care. Pediatrics. 1998 Jun;101(6):E10. doi: 10.1542/peds.101.6.e10.

Barr RG, Rivara FP, Barr M, Cummings P, Taylor J, Lengua LJ, Meredith-Benitz E. Effectiveness of educational materials designed to change knowledge and behaviors regarding crying and shaken-baby syndrome in mothers of newborns: a randomized, controlled trial. Pediatrics. 2009 Mar;123(3):972-80. doi: 10.1542/peds.2008-0908.

Wilson FL, Brown DL, Stephens-Ferris M. Can easy-to-read immunization information increase knowledge in urban low-income mothers? J Pediatr Nurs. 2006 Feb;21(1):4-12. doi: 10.1016/j.pedn.2005.06.003.

Swartz EN. The readability of paediatric patient information materials: Are families satisfied with our handouts and brochures? Paediatr Child Health. 2010 Oct;15(8):509-13. doi: 10.1093/pch/15.8.509.

Dias MS, Smith K, DeGuehery K, Mazur P, Li V, Shaffer ML. Preventing abusive head trauma among infants and young children: a hospital-based, parent education program. Pediatrics. 2005 Apr;115(4):e470-7. doi: 10.1542/peds.2004-1896.

Powell EC, Tanz RR, Uyeda A, Gaffney MB, Sheehan KM. Injury prevention education using pictorial information. Pediatrics. 2000 Jan;105(1):e16. doi: 10.1542/peds.105.1.e16.

Moon RY, Omron R. Determinants of infant sleep position in an urban population. Clin Pediatr (Phila). 2002 Oct;41(8):569-73. doi: 10.1177/000992280204100803.

Joyner BL, Gill-Bailey C, Moon RY. Infant sleep environments depicted in magazines targeted to women of childbearing age. Pediatrics. 2009 Sep;124(3):e416-22. doi: 10.1542/peds.2008-3735. Epub 2009 Aug 17.

Schuster MA, Duan N, Regalado M, Klein DJ. Anticipatory guidance: what information do parents receive? What information do they want? Arch Pediatr Adolesc Med. 2000 Dec;154(12):1191-8. doi: 10.1001/archpedi.154.12.1191.

National Institutes of Health. Clear Communication: A NIH Health Literacy Initiative. 2013; http://www.nih.gov/clearcommunication/healthliteracy.

Yin HS, Johnson M, Mendelsohn AL, Abrams MA, Sanders LM, Dreyer BP. The health literacy of parents in the United States: a nationally representative study. Pediatrics. 2009 Nov;124 Suppl 3:S289-98. doi: 10.1542/peds.2009-1162E.

Sanders LM, Federico S, Klass P, Abrams MA, Dreyer B. Literacy and child health: a systematic review. Arch Pediatr Adolesc Med. 2009 Feb;163(2):131-40. doi: 10.1001/archpediatrics.2008.539.

DeWalt DA, Dilling MH, Rosenthal MS, Pignone MP. Low parental literacy is associated with worse asthma care measures in children. Ambul Pediatr. 2007 Jan-Feb;7(1):25-31. doi: 10.1016/j.ambp.2006.10.001.

Ross LA, Frier BM, Kelnar CJ, Deary IJ. Child and parental mental ability and glycaemic control in children with Type 1 diabetes. Diabet Med. 2001 May;18(5):364-9. doi: 10.1046/j.1464-5491.2001.00468.x.

Morrison AK, Chanmugathas R, Schapira MM, Gorelick MH, Hoffmann RG, Brousseau DC. Caregiver low health literacy and nonurgent use of the pediatric emergency department for febrile illness. Acad Pediatr. 2014 Sep-Oct;14(5):505-9. doi: 10.1016/j.acap.2014.05.001. Epub 2014 Jun 16.

Driessnack M, Chung S, Perkhounkova E, Hein M. Using the "Newest Vital Sign" to assess health literacy in children. J Pediatr Health Care. 2014 Mar-Apr;28(2):165-71. doi: 10.1016/j.pedhc.2013.05.005. Epub 2013 Jul 30.

Abrams MA, Klass P, Dreyer BP. Health literacy and children: recommendations for action. Pediatrics. 2009 Nov;124 Suppl 3:S327-31. doi: 10.1542/peds.2009-1162I. No abstract available.

Davis TC, Mayeaux EJ, Fredrickson D, Bocchini JA Jr, Jackson RH, Murphy PW. Reading ability of parents compared with reading level of pediatric patient education materials. Pediatrics. 1994 Mar;93(3):460-8.

Mendelsohn AL, Mogilner LN, Dreyer BP, Forman JA, Weinstein SC, Broderick M, Cheng KJ, Magloire T, Moore T, Napier C. The impact of a clinic-based literacy intervention on language development in inner-city preschool children. Pediatrics. 2001 Jan;107(1):130-4. doi: 10.1542/peds.107.1.130.

Needlman R, Toker KH, Dreyer BP, Klass P, Mendelsohn AL. Effectiveness of a primary care intervention to support reading aloud: a multicenter evaluation. Ambul Pediatr. 2005 Jul-Aug;5(4):209-15. doi: 10.1367/A04-110R.1.

Sharif I, Rieber S, Ozuah PO. Exposure to Reach Out and Read and vocabulary outcomes in inner city preschoolers. J Natl Med Assoc. 2002 Mar;94(3):171-7. Erratum In: J Natl Med Assoc 2002 Sep;94(9):following table of contents. Reiber Sarah [corrected to Rieber Sarah].

Berkule SB, Dreyer BP, Huberman HS, Fierman AH, Mendelsohn AL. Attitudes about shared reading among at-risk mothers of newborn babies. Ambul Pediatr. 2007 Jan-Feb;7(1):45-50. doi: 10.1016/j.ambp.2006.10.004.

Berkule SB, Dreyer BP, Klass PE, Huberman HS, Yin HS, Mendelsohn AL. Mothers' expectations for shared reading after delivery: implications for reading activities at 6 months. Ambul Pediatr. 2008 May-Jun;8(3):169-74. doi: 10.1016/j.ambp.2008.01.002. Epub 2008 Apr 8.

Moon RY, Cheng TL, Patel KM, Baumhaft K, Scheidt PC. Parental literacy level and understanding of medical information. Pediatrics. 1998 Aug;102(2):e25. doi: 10.1542/peds.102.2.e25.

Freda MC. The readability of American Academy of Pediatrics patient education brochures. J Pediatr Health Care. 2005 May-Jun;19(3):151-6. doi: 10.1016/j.pedhc.2005.01.013.

Rankin SH, Stallings KD. Patient Education: Principles and Practices. 4th ed. Philadelphia: Lippincott WIlliams and Wilkins; 2001.

D'Alessandro DM, Kingsley P, Johnson-West J. The readability of pediatric patient education materials on the World Wide Web. Arch Pediatr Adolesc Med. 2001 Jul;155(7):807-12. doi: 10.1001/archpedi.155.7.807.

Yin HS, Dreyer BP, van Schaick L, Foltin GL, Dinglas C, Mendelsohn AL. Randomized controlled trial of a pictogram-based intervention to reduce liquid medication dosing errors and improve adherence among caregivers of young children. Arch Pediatr Adolesc Med. 2008 Sep;162(9):814-22. doi: 10.1001/archpedi.162.9.814.

French GM, Nicholson L, Skybo T, Klein EG, Schwirian PM, Murray-Johnson L, Sternstein A, Eneli I, Boettner B, Groner JA. An evaluation of mother-centered anticipatory guidance to reduce obesogenic infant feeding behaviors. Pediatrics. 2012 Sep;130(3):e507-17. doi: 10.1542/peds.2011-3027. Epub 2012 Aug 13.

Miller TR, Galbraith M. Injury prevention counseling by pediatricians: a benefit-cost comparison. Pediatrics. 1995 Jul;96(1 Pt 1):1-4.

Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.

Sanders LM, Shaw JS, Guez G, Baur C, Rudd R. Health literacy and child health promotion: implications for research, clinical care, and public policy. Pediatrics. 2009 Nov;124 Suppl 3:S306-14. doi: 10.1542/peds.2009-1162G.

Zuckerman B, Augustyn M. Books and reading: evidence-based standard of care whose time has come. Acad Pediatr. 2011 Jan-Feb;11(1):11-7. doi: 10.1016/j.acap.2010.09.007.

Reich SM, Penner EK, Duncan GJ, Auger A. Using baby books to change new mothers' attitudes about corporal punishment. Child Abuse Negl. 2012 Feb;36(2):108-17. doi: 10.1016/j.chiabu.2011.09.017. Epub 2012 Mar 3.

Bauer NS, Hus AM, Sullivan PD, Szczepaniak D, Carroll AE, Downs SM. A pilot study using children's books to understand caregiver perceptions of parenting practices. J Dev Behav Pediatr. 2012 Jun;33(5):423-30. doi: 10.1097/DBP.0b013e3182560d87.

Reich SM, Bickman L, Saville BR, Alvarez J. The effectiveness of baby books for providing pediatric anticipatory guidance to new mothers. Pediatrics. 2010 May;125(5):997-1002. doi: 10.1542/peds.2009-2728. Epub 2010 Apr 12.

Klass P, Dreyer BP, Mendelsohn AL. Reach out and read: literacy promotion in pediatric primary care. Adv Pediatr. 2009;56:11-27. doi: 10.1016/j.yapd.2009.08.009. No abstract available.

Hartling L, Scott S, Pandya R, Johnson D, Bishop T, Klassen TP. Storytelling as a communication tool for health consumers: development of an intervention for parents of children with croup. Stories to communicate health information. BMC Pediatr. 2010 Sep 2;10:64. doi: 10.1186/1471-2431-10-64.

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.

Davis TC, Long SW, Jackson RH, Mayeaux EJ, George RB, Murphy PW, Crouch MA. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med. 1993 Jun;25(6):391-5.

Bass PF 3rd, Wilson JF, Griffith CH. A shortened instrument for literacy screening. J Gen Intern Med. 2003 Dec;18(12):1036-8. doi: 10.1111/j.1525-1497.2003.10651.x.

Task Force on Sudden Infant Death Syndrome; Moon RY. SIDS and other sleep-related infant deaths: expansion of recommendations for a safe infant sleeping environment. Pediatrics. 2011 Nov;128(5):1030-9. doi: 10.1542/peds.2011-2284. Epub 2011 Oct 17.

Whitehurst GJ. Dialogic Reading: An Effective Way to Read to Preschoolers. 2013; http://www.readingrockets.org/article/400/.

Council on Communications and Media; Brown A. Media use by children younger than 2 years. Pediatrics. 2011 Nov;128(5):1040-5. doi: 10.1542/peds.2011-1753. Epub 2011 Oct 17.

Duch H, Fisher EM, Ensari I, Harrington A. Screen time use in children under 3 years old: a systematic review of correlates. Int J Behav Nutr Phys Act. 2013 Aug 23;10:102. doi: 10.1186/1479-5868-10-102.

Mendelsohn AL, Berkule SB, Tomopoulos S, Tamis-LeMonda CS, Huberman HS, Alvir J, Dreyer BP. Infant television and video exposure associated with limited parent-child verbal interactions in low socioeconomic status households. Arch Pediatr Adolesc Med. 2008 May;162(5):411-7. doi: 10.1001/archpedi.162.5.411.

Hutton JS, Lin L, Gruber R, Berndsen J, DeWitt T, Van Ginkel JB, Ammerman RT. Shared Reading and Television Across the Perinatal Period in Low-SES Households. Clin Pediatr (Phila). 2018 Jul;57(8):904-912. doi: 10.1177/0009922817737077. Epub 2017 Oct 25.