Child DevelopmentELPINCT02713659
Early Literacy Promotion Intervention
A study testing Early Literacy Promotion and Standard Literacy Promotion in people with Child Development, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study is testing the effects of early literacy promotion compared to standard literacy promotion at The Children's Hospital of Philadelphia. Eligible participants and their families will be consented and randomly assigned into either a standard literacy program or an early literacy program. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Early Literacy Promotion and Standard Literacy Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English or Spanish speaking
- Mothers 15 years of age or older at the start of the study
- Child born ≥ 35 weeks estimated gestational age (EGA)
- Child less than 4 weeks old at enrollment
- Child with Medicaid Insurance
Who cannot join
- Child born premature < 35 weeks EGA
- Children with neurodevelopmental disabilities or congenital malformation at increased risk of language delays
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Early Literacy Promotion Among Poor Urban Children in Philadelphia
This study is testing the effects of early literacy promotion compared to standard literacy promotion at The Children's Hospital of Philadelphia. Eligible participants and their families will be consented and randomly assigned into either a standard literacy program or an early literacy program. Standard literacy will consist of the receipt of books and reading promotion beginning at 6 months of age, while early literacy will consist of the receipt of books and reading promotion beginning in the newborn period. In both groups, participants will receive weekly text messages until the child is 6 months old (the text messages will either about reading or safety) and have follow-up study visits at 6, 12, 18, and 24 months. The study will examine the effects of the intervention on language development and reading behaviors.
Read the detailed description
Poor urban children are at an increased risk for language and cognitive delays. Such delays can lead to poor school readiness and disparities in educational outcomes when compared to children from middle and upper income strata. Reach Out and Read (ROR), a national program which promotes parent-child reading activities for children 6 months through 5 years of age at pediatric well child visits, has been shown to improve at-risk children's expressive and receptive language development. However, poor children who participate in ROR still demonstrate language outcomes that are below national averages. It isn't clear whether early literacy promotion, i.e. promotion of parent-child reading prior to six months of age, is more effective than standard literacy promotion and can further improve poor children's language and cognitive outcomes. Therefore, this study will test the effectiveness of early literacy promotion compared to standard literacy promotion among poor at-risk children. Children with Medicaid insurance who are under 1 month of age, were born at least 35 weeks gestation, whose mothers speak English or Spanish and are 15 years of age and older, and are without any neurodevelopmental disabilities will be eligible to participate. One to two urban practices affiliated with The Children's Hospital of Philadelphia (CHOP) who have implemented ROR as standard practice will be recruited to participate. One hundred twenty eligible children attending participating practices will be recruited to participate and consented, stratified by practice site, and randomized to receive early literacy promotion or standard literacy promotion. Early literacy promotion will consist of the provision of developmentally appropriate books selected specifically for well visits starting from one month of age to six months; discussion of the importance of reading, talking, and singing by pediatric clinicians; and text message reminders to parents concerning early literacy and daily reading. Standard literacy promotion will consist of the Reach Out and Read Program with provision of developmentally appropriate books at all well visits from six months of age onward and promotion of reading, talking, and singing activities by pediatric clinicians. Mothers will complete study measures consisting of demographic characteristics, postpartum depression symptoms, health literacy, and adverse childhood experiences at enrollment, and mothers and children will complete measures of reading activity (Stim-Q) at 6, 12, 18, and 24 months of age and child expressive and receptive language development (Preschool Language Scale) at 6 and 24 months of age. Differences in child language outcomes will be assessed using intention-to-treat. Results of this study will be disseminated to key stakeholders through peer-reviewed manuscripts, reports, social media, and evidence-to-action briefs prepared by Policylab at the Children's Hospital of Philadelphia. Study findings will be of importance to the Annie E. Casey Foundation's Read! By 4th in Philadelphia and other community Grade-Level Reading Campaigns, the Clinton Foundation's Too Small to Fail initiative to advance early brain development, and Great Start Collaborative's Early to Read campaign.
- Conditions
- Child Development
- Being tested
- Early Literacy Promotion, Standard Literacy Promotion
- Keywords
- Literacy, Child Development, Reading
- 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 PromotionBehavioural
Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, both groups will receive standard literacy promotion and will attend study visits every six months until age 2.
Standard Literacy PromotionBehavioural
Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, both groups will receive standard literacy promotion and will attend study visits every six months until age 2.
| Study group | Role | What they receive |
|---|---|---|
| Early Literacy Promotion | Experimental | Parents and children randomized to the Early Literacy Promotion arm. Receives: Behavioral: Early Literacy Promotion |
| Standard Literacy Promotion | Active comparator | Parents and children randomized to the Standard Literacy Promotion arm. Receives: Behavioral: Standard Literacy Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preschool Language Scale-5th Edition Score
The Preschool Language Scale-5th Edition (PLS) is a validated measure of expressive and receptive language function among children from birth through 7 years of age and is available in Spanish and English. PLS-5 provides three norm-referenced standard scores: Auditory Comprehension (AC) standard score, Expressive Communication (EC) standard score, and Total Language (TL) composite score. The scores are on a normalized standard score scale that has a mean of 100 and a standard deviation of 15 with scores ranging from 0-200. Higher scores represent better language development..
Measured: Change in PLS scores from 6 to 24 months of age
Secondary outcomes (2)
Change in StimQ Score
Reading activity is measured using the StimQ Read Subscale, a subscale scale of the overall StimQ that measures the home reading environment among young children ages 5 to 36 months, and is available in Spanish and English. The Read Subscale of the StimQ-I is used for infants 5-12 months old and contains 12 questions, while the Read Subscale of the StimQ-T is used for children aged 12-36 months old and contains 11 questions. Scores range from 0-19 with higher scores representing better home reading environments.
Measured: Change in StimQ score from 6 to 24 months of age
Health Services Utilization
Immunizations and well child visit data will be collected from electronic health records to measure impact of ELP intervention on health services use.
Measured: Birth to 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- William Penn Foundation
- Responsible party
- Sponsor
- Investigators
- James P Guevara, MD, MPH, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713659
- Sponsor's protocol ID
- IRB 15-012507
- Acronym
- ELPI
- Status last verified
- Aug 2019
- First submitted
- 10 Mar 2016
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Following completion of all analyses, data will be de-identified and made available for other investigators.
Publications
Guevara JP, Erkoboni D, Gerdes M, Winston S, Sands D, Rogers K, Haecker T, Jimenez ME, Mendelsohn AL. Effects of Early Literacy Promotion on Child Language Development and Home Reading Environment: A Randomized Controlled Trial. J Pediatr X. 2020 May 11;2:100020. doi: 10.1016/j.ympdx.2020.100020. eCollection 2020 Spring.
PubMed 37332625
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Literacy Promotion Among Poor Urban Children in Philadelphia
- ClinicalTrials.gov ID
- NCT02713659
- Acronym / sponsor ID
- ELPI / IRB 15-012507
- Conditions
- Child Development
- Keywords
- Literacy, Child Development, Reading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- William Penn Foundation
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing the effects of early literacy promotion compared to standard literacy promotion at The Children's Hospital of Philadelphia. Eligible participants and their families will be consented and randomly assigned into either a standard literacy program or an early literacy program. Standard literacy will consist of the receipt of books and reading promotion beginning at 6 months of age, while early literacy will consist of the receipt of books and reading promotion beginning in the newborn period. In both groups, participants will receive weekly text messages until the child is 6 months old (the text messages will either about reading or safety) and have follow-up study visits at 6, 12, 18, and 24 months. The study will examine the effects of the intervention on language development and reading behaviors.
Detailed description
Poor urban children are at an increased risk for language and cognitive delays. Such delays can lead to poor school readiness and disparities in educational outcomes when compared to children from middle and upper income strata. Reach Out and Read (ROR), a national program which promotes parent-child reading activities for children 6 months through 5 years of age at pediatric well child visits, has been shown to improve at-risk children's expressive and receptive language development. However, poor children who participate in ROR still demonstrate language outcomes that are below national averages. It isn't clear whether early literacy promotion, i.e. promotion of parent-child reading prior to six months of age, is more effective than standard literacy promotion and can further improve poor children's language and cognitive outcomes. Therefore, this study will test the effectiveness of early literacy promotion compared to standard literacy promotion among poor at-risk children. Children with Medicaid insurance who are under 1 month of age, were born at least 35 weeks gestation, whose mothers speak English or Spanish and are 15 years of age and older, and are without any neurodevelopmental disabilities will be eligible to participate. One to two urban practices affiliated with The Children's Hospital of Philadelphia (CHOP) who have implemented ROR as standard practice will be recruited to participate. One hundred twenty eligible children attending participating practices will be recruited to participate and consented, stratified by practice site, and randomized to receive early literacy promotion or standard literacy promotion. Early literacy promotion will consist of the provision of developmentally appropriate books selected specifically for well visits starting from one month of age to six months; discussion of the importance of reading, talking, and singing by pediatric clinicians; and text message reminders to parents concerning early literacy and daily reading. Standard literacy promotion will consist of the Reach Out and Read Program with provision of developmentally appropriate books at all well visits from six months of age onward and promotion of reading, talking, and singing activities by pediatric clinicians. Mothers will complete study measures consisting of demographic characteristics, postpartum depression symptoms, health literacy, and adverse childhood experiences at enrollment, and mothers and children will complete measures of reading activity (Stim-Q) at 6, 12, 18, and 24 months of age and child expressive and receptive language development (Preschool Language Scale) at 6 and 24 months of age. Differences in child language outcomes will be assessed using intention-to-treat. Results of this study will be disseminated to key stakeholders through peer-reviewed manuscripts, reports, social media, and evidence-to-action briefs prepared by Policylab at the Children's Hospital of Philadelphia. Study findings will be of importance to the Annie E. Casey Foundation's Read! By 4th in Philadelphia and other community Grade-Level Reading Campaigns, the Clinton Foundation's Too Small to Fail initiative to advance early brain development, and Great Start Collaborative's Early to Read campaign.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Literacy Promotion | Experimental | Behavioral: Early Literacy PromotionParents and children randomized to the Early Literacy Promotion arm. |
| Standard Literacy Promotion | Active comparator | Behavioral: Standard Literacy PromotionParents and children randomized to the Standard Literacy Promotion arm. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- English or Spanish speaking
- Mothers 15 years of age or older at the start of the study
- Child born ≥ 35 weeks estimated gestational age (EGA)
- Child less than 4 weeks old at enrollment
- Child with Medicaid Insurance
Key exclusion criteria (2 listed)
- Child born premature < 35 weeks EGA
- Children with neurodevelopmental disabilities or congenital malformation at increased risk of language delays
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 PromotionParents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, both groups will receive standard literacy promotion and will attend study visits every six months until age 2. | Behavioural | Early Literacy Promotion |
| Standard Literacy PromotionParents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, both groups will receive standard literacy promotion and will attend study visits every six months until age 2. | Behavioural | Standard Literacy Promotion |
Primary outcome
Change in Preschool Language Scale-5th Edition Score
Time frame: Change in PLS scores from 6 to 24 months of age
The Preschool Language Scale-5th Edition (PLS) is a validated measure of expressive and receptive language function among children from birth through 7 years of age and is available in Spanish and English. PLS-5 provides three norm-referenced standard scores: Auditory Comprehension (AC) standard score, Expressive Communication (EC) standard score, and Total Language (TL) composite score. The scores are on a normalized standard score scale that has a mean of 100 and a standard deviation of 15 with scores ranging from 0-200. Higher scores represent better language development..
2 secondary outcomes
Change in StimQ Score
Time frame: Change in StimQ score from 6 to 24 months of age
Health Services Utilization
Time frame: Birth to 6 months of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37332625Guevara JP, Erkoboni D, Gerdes M, Winston S, Sands D, Rogers K, Haecker T, Jimenez ME, Mendelsohn AL. Effects of Early Literacy Promotion on Child Language Development and Home Reading Environment: A Randomized Controlled Trial. J Pediatr X. 2020 May 11;2:100020. doi: 10.1016/j.ympdx.2020.100020. eCollection 2020 Spring.
- Individual participant dataSharing planned: Yes. Following completion of all analyses, data will be de-identified and made available for other investigators.
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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.
James P Guevara, MD, MPH principal investigator
Children's Hospital of Philadelphia
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 Promotion and Standard Literacy Promotion in people with Child Development, run by Children's Hospital of Philadelphia 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 5 inclusion and 2 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 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Preschool Language Scale-5th Edition Score (time frame: Change in PLS scores from 6 to 24 months of age). 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 NCT02713659, which also lists 1 linked publication.
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 Sep 2019.