Sudden Unexplained Infant DeathNCT04031235
Comparing Children's Books to Brochures for Safe Sleep and Infant Reading Education During Prenatal Care
A study testing Sleep Baby, Safe and Snug and Read Baby, Every Day in people with Sudden Unexplained Infant Death and Child Rearing, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The aim of this randomized trial is to compare a specially designed children's book to brochures for safe sleep education via clinical providers at a third trimester prenatal obstetric visit. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sudden Unexplained Infant Death, Child Rearing, Literacy
- What is being tested?
- Sleep Baby, Safe and Snug and Read Baby, Every Day
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 15 Jan 2020
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- confirmed viable pregnancy, with estimated gestational age (EGA) of at least 36 weeks at the baseline/enrollment prenatal visit,
- maternal age at least 16 years old,
- comfort speaking English during their visit and reviewing/comprehending study materials without a translator.
Who cannot join
- Non-meeting the above.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Randomized Controlled Trial Comparing a Children's Book to Brochures for Safe Sleep and Infant Reading Education During Prenatal Obstetric Visits
The aim of this randomized trial is to compare a specially designed children's book to brochures for safe sleep education via clinical providers at a third trimester prenatal obstetric visit. Mothers in the control group will receive a specially designed children's book regarding the importance of reading with their infant at this visit, compared to brochures. Knowledge of safe sleep and home literacy orientation will be assessed at baseline prenatally, and their first postpartum obstetric visit.
Read the detailed description
This study is a randomized controlled trial (RCT) involving 2 groups of pregnant women from low-socioeconomic status (SES) backgrounds at-risk for adverse cognitive and health outcomes for their infant. Mothers will be randomly assigned to intervention and control groups during a third-trimester prenatal visit at a hospital-affiliated obstetric clinic, via convenience sampling. Mothers in the intervention group will receive education on American Academy of Pediatrics (AAP) safe sleep recommendations using a specially-designed children's book (Sleep Baby, Safe and Snug), while those in the control group will receive this guidance via a brochure endorsed by the AAP.
In a "mirror" design, mothers in the control group will receive guidance on reading with their infant using a specially designed children's book (Read Baby, Every Day), and mothers in the intervention group will receive guidance on reading with their infant using a brochure created and endorsed by the AAP.
Clinical research coordinators (CRCs) will obtain consent and collect data at two time points: 1) a 3rd trimester prenatal visit (approximately 36-38 weeks estimated gestational age; baseline), and 2) at the first, regularly scheduled postpartum visit (4-6 weeks after delivery for an uncomplicated vaginal delivery, and 2 weeks for cesarean section). Data will be collected in 4 categories, which will be compared between groups: 1) demographics, 2) maternal knowledge of AAP safe sleep recommendations, 3) maternal attitudes about reading with infants, 4) maternal impression of the printed educational materials provided, and 4) clinician impression of the feasibility and usefulness of the printed materials provided for obstetric prenatal care.
Educational materials will be shared with mothers by obstetric providers (obstetric attending physicians and residents) during this visit, who will be provided with a brief summary of content and to conduct the visit as they see fit. Mothers will be blinded to the aims of the study, other than that it is to "share information about safe sleep and reading with your baby."
- Conditions
- Sudden Unexplained Infant Death, Child Rearing, Literacy
- Being tested
- Sleep Baby, Safe and Snug, Read Baby, Every Day
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Baby, Safe and SnugBehavioural
Specially designed children's book, 14 pages, rhyming, illustrated in color, written at a Kindergarten reading level. Each page spread highlights AAP-recommended safe sleep practices. AAP safe sleep recommendations listed on the back cover.
Read Baby, Every DayBehavioural
Specially designed children's book, 14 pages, rhyming, illustrated in color, written at a Kindergarten reading level. Each page spread highlights AAP-recommendations regarding the importance of reading and talking to infants. Recommendations and benefits of reading with infants are listed on the back cover as well.
| Study group | Role | What they receive |
|---|---|---|
| Safe Sleep Education | Experimental | Mothers in the intervention group will receive education on American Academy of Pediatrics safe sleep recommendations using a specially-designed children's book (Sleep Baby, Safe and Snug). In addition, they will receive information on the importance of reading with their infant using a brochure created by the AAP. Receives: Behavioral: Sleep Baby, Safe and Snug |
| Infant Reading Education | Active comparator | Mothers in the control group will receive education on American Academy of Pediatrics recommendations on reading and talking to infants using a specially-designed children's book (Read Baby, Every Day). In addition, they will receive information on safe sleep using a brochure created by the AAP. Receives: Behavioral: Read Baby, Every Day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe Sleep Knowledge
The safe sleep assessment is based on a version developed by the PI and used in a recent published study, reflecting current AAP guidelines. Three questions are adapted from a published survey, gauging the mother's familiarity with SUID/SIDS (and briefly explaining if unfamiliar), whether she personally knows anyone who has lost a child to SUID/SIDS, and level of worry about SUID/SIDS for her baby. Our primary knowledge question utilizes an open-ended format, as no established tool for measuring SIDS knowledge was available: "Name as many things as you can think of to help keep your baby safe from SUID/SIDS (dying while asleep)." Maternal responses will be compared to an 11-item checklist of AAP safe sleep recommendations which are each referenced at least once in the book and brochures used, with 1 point awarded for each correct response.
Measured: Baseline prenatal (>= 32 weeks) and postpartum (<= 6 weeks).
Maternal impression of educational materials
Mothers will be administered a brief survey (Likert scale) regarding how useful the respective book or brochure were to help them understand safe sleep practices and the importance of infant reading. They will also be asked if they still have the materials and how often they have reviewed them at home.
Measured: Postpartum (<= 6 weeks)
Clinical provider impression of educational materials
Obstetric attending and resident physicians will be administered a brief survey (Likert scale) after the prenatal visit regarding how useful the respective book or brochure was to catalyze discussion of safe sleep and infant reading with the mother, with emphasis on feasibility in clinical practice.
Measured: Prenatal/baseline visit (>=32 weeks gestation)
Secondary outcomes (2)
Home Literacy Orientation
Prenatally, the mother will be administered a brief survey regarding the age at which the mother plans to begin reading with her infant (open-ended), planned frequency of reading (days per week), estimated number of children's books in the home, impression of the usefulness of reading to infants before 2 months old, and the value of discussing reading during prenatal visits (Likert scales). At the postpartum visit, this survey will be expanded to involve access to books, actual reading frequency, home reading routines, and the child's interest in being read to. An additional item regarding attitudes towards reading at home adapted from published research ("What are your 3 favorite things to do with your child these days?", noting if reading is mentioned) will also be asked.
Measured: Baseline prenatal (>= 32 weeks) and postpartum (<= 6 weeks).
DialogPR-I/T
This is an 10-item parental report assessment of shared reading quality created by the principal investigator for caregivers of children under 18 months, based on a conceptual model of practices thought to enhance the reading experience and benefit child development. Score is 0-30 points, with higher score suggesting more nurturing reading behaviors.
Measured: Postpartum (<= 6 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start25 Feb 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sudden Unexplained Infant DeathStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031235
- Sponsor's protocol ID
- 2018-5564
- Status last verified
- Aug 2021
- First submitted
- 16 Feb 2019
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available in a de-identified fashion by written request \& approval.
Publications
Hutton JS, Gupta R, Gruber R, Berndsen J, DeWitt T, Ollberding NJ, Van Ginkel JB, Ammerman RT. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population. Acad Pediatr. 2017 Nov-Dec;17(8):879-886. doi: 10.1016/j.acap.2017.04.018. Epub 2017 Apr 24.
PubMed 28450082Hutton 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.
PubMed 29067842Hutton JS, Huang G, Crosh C, DeWitt T, Ittenbach RF. Shared reading with infants: SharePR a novel measure of shared reading quality. Pediatr Res. 2023 Mar;93(4):976-984. doi: 10.1038/s41390-022-02178-6. Epub 2022 Jul 19.
PubMed 35854086
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 and Infant Reading Education During Prenatal Obstetric Visits
- ClinicalTrials.gov ID
- NCT04031235
- Acronym / sponsor ID
- 2018-5564
- Conditions
- Sudden Unexplained Infant Death, Child Rearing, Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 24 Jul 2019 (actual)
- 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.
The aim of this randomized trial is to compare a specially designed children's book to brochures for safe sleep education via clinical providers at a third trimester prenatal obstetric visit. Mothers in the control group will receive a specially designed children's book regarding the importance of reading with their infant at this visit, compared to brochures. Knowledge of safe sleep and home literacy orientation will be assessed at baseline prenatally, and their first postpartum obstetric visit.
Detailed description
This study is a randomized controlled trial (RCT) involving 2 groups of pregnant women from low-socioeconomic status (SES) backgrounds at-risk for adverse cognitive and health outcomes for their infant. Mothers will be randomly assigned to intervention and control groups during a third-trimester prenatal visit at a hospital-affiliated obstetric clinic, via convenience sampling. Mothers in the intervention group will receive education on American Academy of Pediatrics (AAP) safe sleep recommendations using a specially-designed children's book (Sleep Baby, Safe and Snug), while those in the control group will receive this guidance via a brochure endorsed by the AAP.
In a "mirror" design, mothers in the control group will receive guidance on reading with their infant using a specially designed children's book (Read Baby, Every Day), and mothers in the intervention group will receive guidance on reading with their infant using a brochure created and endorsed by the AAP.
Clinical research coordinators (CRCs) will obtain consent and collect data at two time points: 1) a 3rd trimester prenatal visit (approximately 36-38 weeks estimated gestational age; baseline), and 2) at the first, regularly scheduled postpartum visit (4-6 weeks after delivery for an uncomplicated vaginal delivery, and 2 weeks for cesarean section). Data will be collected in 4 categories, which will be compared between groups: 1) demographics, 2) maternal knowledge of AAP safe sleep recommendations, 3) maternal attitudes about reading with infants, 4) maternal impression of the printed educational materials provided, and 4) clinician impression of the feasibility and usefulness of the printed materials provided for obstetric prenatal care.
Educational materials will be shared with mothers by obstetric providers (obstetric attending physicians and residents) during this visit, who will be provided with a brief summary of content and to conduct the visit as they see fit. Mothers will be blinded to the aims of the study, other than that it is to "share information about safe sleep and reading with your baby."
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safe Sleep Education | Experimental | Behavioral: Sleep Baby, Safe and SnugMothers in the intervention group will receive education on American Academy of Pediatrics safe sleep recommendations using a specially-designed children's book (Sleep Baby, Safe and Snug). In addition, they will receive information on the importance of reading with their infant using a brochure created by the AAP. |
| Infant Reading Education | Active comparator | Behavioral: Read Baby, Every DayMothers in the control group will receive education on American Academy of Pediatrics recommendations on reading and talking to infants using a specially-designed children's book (Read Baby, Every Day). In addition, they will receive information on safe sleep using a brochure created by the AAP. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed viable pregnancy, with estimated gestational age (EGA) of at least 36 weeks at the baseline/enrollment prenatal visit,
- maternal age at least 16 years old,
- comfort speaking English during their visit and reviewing/comprehending study materials without a translator.
Key exclusion criteria (1 listed)
- Non-meeting the above.
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 |
|---|---|---|
| Sleep Baby, Safe and SnugSpecially designed children's book, 14 pages, rhyming, illustrated in color, written at a Kindergarten reading level. Each page spread highlights AAP-recommended safe sleep practices. AAP safe sleep recommendations listed on the back cover. | Behavioural | Safe Sleep Education |
| Read Baby, Every DaySpecially designed children's book, 14 pages, rhyming, illustrated in color, written at a Kindergarten reading level. Each page spread highlights AAP-recommendations regarding the importance of reading and talking to infants. Recommendations and benefits of reading with infants are listed on the back cover as well. | Behavioural | Infant Reading Education |
Primary outcome
Safe Sleep Knowledge
Time frame: Baseline prenatal (>= 32 weeks) and postpartum (<= 6 weeks).
The safe sleep assessment is based on a version developed by the PI and used in a recent published study, reflecting current AAP guidelines. Three questions are adapted from a published survey, gauging the mother's familiarity with SUID/SIDS (and briefly explaining if unfamiliar), whether she personally knows anyone who has lost a child to SUID/SIDS, and level of worry about SUID/SIDS for her baby. Our primary knowledge question utilizes an open-ended format, as no established tool for measuring SIDS knowledge was available: "Name as many things as you can think of to help keep your baby safe from SUID/SIDS (dying while asleep)." Maternal responses will be compared to an 11-item checklist of AAP safe sleep recommendations which are each referenced at least once in the book and brochures used, with 1 point awarded for each correct response.
Maternal impression of educational materials
Time frame: Postpartum (<= 6 weeks)
Mothers will be administered a brief survey (Likert scale) regarding how useful the respective book or brochure were to help them understand safe sleep practices and the importance of infant reading. They will also be asked if they still have the materials and how often they have reviewed them at home.
Clinical provider impression of educational materials
Time frame: Prenatal/baseline visit (>=32 weeks gestation)
Obstetric attending and resident physicians will be administered a brief survey (Likert scale) after the prenatal visit regarding how useful the respective book or brochure was to catalyze discussion of safe sleep and infant reading with the mother, with emphasis on feasibility in clinical practice.
2 secondary outcomes
Home Literacy Orientation
Time frame: Baseline prenatal (>= 32 weeks) and postpartum (<= 6 weeks).
DialogPR-I/T
Time frame: Postpartum (<= 6 weeks).
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 28450082Hutton JS, Gupta R, Gruber R, Berndsen J, DeWitt T, Ollberding NJ, Van Ginkel JB, Ammerman RT. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population. Acad Pediatr. 2017 Nov-Dec;17(8):879-886. doi: 10.1016/j.acap.2017.04.018. Epub 2017 Apr 24.
- Background: PubMed 29067842Hutton 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.
- Derived from this study: PubMed 35854086Hutton JS, Huang G, Crosh C, DeWitt T, Ittenbach RF. Shared reading with infants: SharePR a novel measure of shared reading quality. Pediatr Res. 2023 Mar;93(4):976-984. doi: 10.1038/s41390-022-02178-6. Epub 2022 Jul 19.
- Individual participant dataSharing planned: No. Available in a de-identified fashion by written request \& approval.
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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 Sleep Baby, Safe and Snug and Read Baby, Every Day in people with Sudden Unexplained Infant Death and Child Rearing, 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 1 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?
Safe Sleep Knowledge (time frame: Baseline prenatal (>= 32 weeks) and postpartum (<= 6 weeks).). The study lists 3 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 NCT04031235, which also lists 3 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.