Sudden Infant Death Syndrome (SIDS)NCT02376673
Comparing Children's Book to Brochures for Safe Sleep Education in a Home Visiting Program
A study testing Children's Book and Standard Brochures in people with Sudden Infant Death Syndrome (SIDS), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sudden Infant Death Syndrome (SIDS)
- What is being tested?
- Children's Book and Standard Brochures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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
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.
Read the 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).
- Conditions
- Sudden Infant Death Syndrome (SIDS)
- Being tested
- Children's Book, Standard Brochures
- Keywords
- Pediatric Health Literacy, Home Literacy Orientation, safe sleep
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children's BookOther
Also called Sleep Baby, Safe and Snug
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.
Standard BrochuresOther
Also called What does a safe sleep environment look like?, Bright Futures - Newborn Visit, Home Safe Home - Sleep, Helping Baby Back to Sleep
An assortment of standard safe sleep educational brochures provided by home visitors during prescribed home visits, covering various recommendations for safe sleep.
| Study group | Role | What they receive |
|---|---|---|
| Brochures | Active comparator | 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. Receives: Other: Standard Brochures |
| Children's Book | Experimental | 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. Receives: Other: Children's Book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Maternal Safe Sleep Knowledge
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.
Measured: Prenatal baseline to 1 week and 2 months postnatally
Assessment of Infant Sleep Environment
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
Measured: During study home visits 1 week and 2 months postnatally
Maternal Impression of Safe Sleep Materials Provided
Maternal impression of printed materials (book or brochures) used for safe sleep teaching, content and usefulness.
Measured: At study home visits 1 week and 2 months postnatally
Home Visitor Impression of Safe Sleep Materials Provided
Home visitor impression of printed materials (book or brochures) used for safe sleep teaching, time of delivery and usefulness.
Measured: At each study home visit: prenatal, 1 week, and 2 months postnatally
Secondary outcomes (2)
Maternal Health Literacy Screen
Maternal health literacy screen using the validated REALM-R measure (recognizing and pronouncing medical words)
Measured: One time prenatally
Change in Home Literacy Orientation
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.
Measured: Baseline prenatally and 2 months postnatally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (67)Papers the sponsor has linked to this study.
- Other trials for Sudden Infant Death Syndrome (SIDS)Studies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- de Cavel Family SIDS Foundation, Every Child Succeeds
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376673
- Sponsor's protocol ID
- CincinnatiChildrens
- Status last verified
- Aug 2021
- First submitted
- 19 Feb 2015
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22753789Reich 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.
PubMed 21272822Zuckerman 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.
PubMed 20601887Vennemann 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.
PubMed 21868032Murphy SL, Xu J, Kochanek KD. Deaths: final data for 2010. Natl Vital Stat Rep. 2013 May 8;61(4):1-117.
PubMed 24979972Wymyslo 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.
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.
PubMed 9247009Hauck 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.
PubMed 21669892Moon 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.
PubMed 21505778Moon 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.
PubMed 14993547Fu 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.
PubMed 18582898Robida 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.
PubMed 22904266Ottolini 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.
PubMed 10323633Cowan 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.
PubMed 23437780
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02376673
- Acronym / sponsor ID
- CincinnatiChildrens
- Conditions
- Sudden Infant Death Syndrome (SIDS)
- Keywords
- Pediatric Health Literacy, Home Literacy Orientation, safe sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- de Cavel Family SIDS Foundation, Every Child Succeeds
- Study start
- Jun 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brochures | Active comparator | Other: Standard BrochuresMothers 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. |
| Children's Book | Experimental | Other: Children's BookMothers 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Children's BookAlso: Sleep Baby, Safe and SnugA 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 | Children's Book |
| Standard BrochuresAlso: What does a safe sleep environment look like?, Bright Futures - Newborn Visit, Home Safe Home - Sleep, Helping Baby Back to SleepAn assortment of standard safe sleep educational brochures provided by home visitors during prescribed home visits, covering various recommendations for safe sleep. | Other | Brochures |
Primary outcome
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.
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
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.
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.
2 secondary outcomes
Maternal Health Literacy Screen
Time frame: One time prenatally
Change in Home Literacy Orientation
Time frame: Baseline prenatally and 2 months postnatally
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Background: PubMed 22753789Moon RY, Fu L. Sudden infant death syndrome: an update. Pediatr Rev. 2012 Jul;33(7):314-20. doi: 10.1542/pir.33-7-314.
- Background: PubMed 21272822Reich 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.
- Background: PubMed 20601887Zuckerman 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.
- Background: PubMed 21868032Vennemann 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.
- Background: PubMed 24979972Murphy SL, Xu J, Kochanek KD. Deaths: final data for 2010. Natl Vital Stat Rep. 2013 May 8;61(4):1-117.
- BackgroundWymyslo T, Director. Ohio Child Fatality Review Twelfth Annual Report: 2006-2010, 2012.
- BackgroundMaseru, N. P. D., MPH. (2011). Cincinnati-Hamilton County Fetal-Infant Mortality Review. Cincinnat, OH.
- Background: PubMed 9247009MacDorman 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.
- Background: PubMed 21669892Hauck 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.
- Background: PubMed 21505778Moon 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.
- Background: PubMed 14993547Moon 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.
- Background: PubMed 18582898Fu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Children's Book and Standard Brochures in people with Sudden Infant Death Syndrome (SIDS), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change In Maternal Safe Sleep Knowledge (time frame: Prenatal baseline to 1 week and 2 months postnatally). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02376673, which also lists 67 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.