LiteracyNCT04147429
Newborn Nursery Reach Out and Read
A study testing Early Literacy Intervention in people with Literacy, run by Duke University at 1 site in United States.
Trial summary
The purpose of this research study is to learn new things about how parents and others who care for babies think about sharing books with their baby and how they might respond to guidance from their doctors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Literacy
- What is being tested?
- Early Literacy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2019to 18 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child delivered at Duke Hospital Birthing Center
- Families who can read and write in English
- Families with children born at >36 weeks gestation
- Families who plan to continue primary pediatric care with Duke Children's Primary Care
Who cannot join
- Parent with severe medical or mental health condition limiting ability to attend appointments
- Newborn with severe medical condition
- Families who plan to move out of state in the next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Reach Out and Read From Cradle to Clinic: A Novel Reach Out and Read Intervention in the Newborn Nursery
The purpose of this research study is to learn new things about how parents and others who care for babies think about sharing books with their baby and how they might respond to guidance from their doctors. The study involves participants filling out a survey with questions about a newborn baby and thoughts about the baby's development. The study should not take more than an hour and fifteen minutes during the delivery hospital stay and another 20 minutes at the baby's one month well child visit by phone or emailed survey link. Participants may also be interviewed and asked some questions about these topics. The conversation will be audio recorded, and should last no more than 30 minutes. The survey should take no more than 15 minutes to complete. The participant and their child will be randomized, like flipping a coin, to either receive the study intervention book, Cluck and Moo, along with standard or care or solely standard of care at your time of hospital discharge. The greatest risks to this study would be feeling uncomfortable about answering some of the questions and potential risk of loss of confidentiality.
- Conditions
- Literacy
- Being tested
- Early Literacy Intervention
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Literacy InterventionBehavioural
Similar to the standard Reach out and Read model, parents will be given a high-contrast board book, Cluck and Moo, and education about the importance of and how to engage with newborns in early shared reading behaviors. This will include instructive information for families about using books to stimulate newborns through pictures and spoken words.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Newborns randomized to the usual care group will receive standard education about safe sleep practices, measuring temperatures and newborn feeding needs. This information will be accompanied by printed instructions that will be added to the family's discharge instructions. This reflects current practice in the Duke Hospital Newborn Nursery. |
| Intervention | Experimental | In addition to usual care, families randomized to the intervention group will receive an early literacy intervention, delivered by a trained research assistant. To ensure intervention and delivery fidelity, the PI will meet with research assistants at bi-weekly intervals to review procedures and perform structured observations of intervention delivery. Receives: Behavioral: Early Literacy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program acceptability as measured by survey data
Survey data will be analyzed using grounded theory.
Measured: 1 month
Program acceptability as measured by structured interviews
The structured interviews will be evaluated and themes and subthemes will be identified using NVivo software.
Measured: 1 month
Program feasibility assessed by determining the cost of books required for the intervention
Measured: 1 month
Program feasibility assessed by the time required to complete enrollment
Measured: 1 month
Program feasibility assessed by the time required to complete the intervention
Measured: 1 month
Program feasibility assessed by the number of eligible families enrolled in the study.
Measured: 1 month
Program feasibility assessed by the percentage of families who are followed through to study completion
Measured: 1 month
Secondary outcomes (1)
Family's home literacy environment as measured by the READ subscale of the StimQ2-Infant.
Age appropriate items will be pulled from the StimQ2-Infant READ subscale. The StimQ2-Infant READ subscale measures a family's shared reading behaviors in the home.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start30 Oct 2019
- Primary completion18 Apr 2020
- Study completion18 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Erickson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147429
- Sponsor's protocol ID
- Pro00102414
- Status last verified
- Feb 2020
- First submitted
- 30 Oct 2019
- Last updated
- 27 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reach Out and Read From Cradle to Clinic: A Novel Reach Out and Read Intervention in the Newborn Nursery
- ClinicalTrials.gov ID
- NCT04147429
- Acronym / sponsor ID
- Pro00102414
- Conditions
- Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 18 Apr 2020 (actual)
- Study completion
- 18 Apr 2020 (actual)
- First posted
- 1 Nov 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 purpose of this research study is to learn new things about how parents and others who care for babies think about sharing books with their baby and how they might respond to guidance from their doctors. The study involves participants filling out a survey with questions about a newborn baby and thoughts about the baby's development. The study should not take more than an hour and fifteen minutes during the delivery hospital stay and another 20 minutes at the baby's one month well child visit by phone or emailed survey link. Participants may also be interviewed and asked some questions about these topics. The conversation will be audio recorded, and should last no more than 30 minutes. The survey should take no more than 15 minutes to complete. The participant and their child will be randomized, like flipping a coin, to either receive the study intervention book, Cluck and Moo, along with standard or care or solely standard of care at your time of hospital discharge. The greatest risks to this study would be feeling uncomfortable about answering some of the questions and potential risk of loss of confidentiality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Newborns randomized to the usual care group will receive standard education about safe sleep practices, measuring temperatures and newborn feeding needs. This information will be accompanied by printed instructions that will be added to the family's discharge instructions. This reflects current practice in the Duke Hospital Newborn Nursery. |
| Intervention | Experimental | Behavioral: Early Literacy InterventionIn addition to usual care, families randomized to the intervention group will receive an early literacy intervention, delivered by a trained research assistant. To ensure intervention and delivery fidelity, the PI will meet with research assistants at bi-weekly intervals to review procedures and perform structured observations of intervention delivery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Child delivered at Duke Hospital Birthing Center
- Families who can read and write in English
- Families with children born at >36 weeks gestation
- Families who plan to continue primary pediatric care with Duke Children's Primary Care
Key exclusion criteria (3 listed)
- Parent with severe medical or mental health condition limiting ability to attend appointments
- Newborn with severe medical condition
- Families who plan to move out of state in the next 6 months
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 |
|---|---|---|
| Early Literacy InterventionSimilar to the standard Reach out and Read model, parents will be given a high-contrast board book, Cluck and Moo, and education about the importance of and how to engage with newborns in early shared reading behaviors. This will include instructive information for families about using books to stimulate newborns through pictures and spoken words. | Behavioural | Intervention |
Primary outcome
Program acceptability as measured by survey data
Time frame: 1 month
Survey data will be analyzed using grounded theory.
Program acceptability as measured by structured interviews
Time frame: 1 month
The structured interviews will be evaluated and themes and subthemes will be identified using NVivo software.
Program feasibility assessed by determining the cost of books required for the intervention
Time frame: 1 month
Program feasibility assessed by the time required to complete enrollment
Time frame: 1 month
Program feasibility assessed by the time required to complete the intervention
Time frame: 1 month
Program feasibility assessed by the number of eligible families enrolled in the study.
Time frame: 1 month
Program feasibility assessed by the percentage of families who are followed through to study completion
Time frame: 1 month
1 secondary outcome
Family's home literacy environment as measured by the READ subscale of the StimQ2-Infant.
Time frame: 1 month
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 27 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Elizabeth Erickson, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Literacy Intervention in people with Literacy, run by Duke University 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 4 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 27 Jul 2020. 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?
Program acceptability as measured by survey data (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2020.