LiteracyNCT04752943

Leveraging Clinic to Promote Literacy in Young Children

A study testing Tips By Text Messages in people with Literacy, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Literacy
What is being tested?: Tips By Text Messages
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 381 participants
Where: 1 siteUnited States
Study dates: 16 Oct 2017to 26 Jul 2019
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 3 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Parents of participants must be last least 18 years of age.
Parents must be English and Spanish speaking, as the Tips by Text texting platform is currently in those languages.
Child must be 3-5 years old at the time of their clinic visit.

Who cannot join

Parent does not speak English or Spanish. This applies given that the texting intervention has the capacity to be conducted in these two languages.
Parent does not have cell phone that would allow texting.
For the literacy texting intervention, the child must NOT be enrolled in Head Start,Transitional Kindergarten or other subsidized preschool. Parents will be provided with a list of preschools that would warrant exclusion. Childcare is ok. For the trust and no-show evaluation arm, participants may be enrolled in any form of early childhood education.
Child is currently receiving services for delay (speech, motor, or cognitive). If the child briefly received services for delays over a year before start date of the study, they are still eligible.

Trial locations and contacts

1 site in 1 country.

United States1 site

Valley Medical Center
San Jose, California, 95128

Other trials in United States

About this study

Official title: Tips By Text: Using Text Messages to Support Clinic Parents and Improve Child School Readiness Outcomes

Our primary aim of this study is to assess the impact of an early literacy text messaging program (TipsByText, TbT) for parents of children between 3 to 4-years old during an office visit without access to preschool. To assess this aim, our objectives are to specifically assess (1) child literacy using the Phonological Awareness Literacy Screening Tool (PALS-PreK) and (2) caregiver involvement using the Parent Child Interactivity Scale (PCI) pre- and post-intervention, comparing with a control group not receiving the TipsByText intervention. A secondary outcome of this study is to compare trust among families that participate in the Tips by Text (TbT) Program with families that do not participate in TbT using the Trust Evaluation Scale. Children will complete the PALS-PreK and caregivers of the children will complete the PCI and Trust Evaluation Scales.

Conditions: Literacy
Being tested: Tips By Text Messages
Keywords: school readiness
Medical subject headings: Literacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tips By Text MessagesOther
Texts sent to caregivers meant to increase parent child interaction around literacy, sent to participants 3 x a week for 7 months

Study groups in NCT04752943
Study group	Role	What they receive
Children and caregivers receiving TipsByText messages	Experimental	Not described Receives: Other: Tips By Text Messages
Children and caregivers not receiving TipsByText texts	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in child literacy measured by the Phonological Awareness Literacy Screening Tool (PALS-PreK) Score
The PALS-PreK measures preschoolers' knowledge of literacy fundamentals: name writing, alphabet knowledge, sound awareness, print and word awareness, rhyme awareness, and nursery rhyme awareness. The English and Spanish PALS-PreK versions slightly differ in content, thus we standardized composite scores for both the pre and post score by language to allow fair comparisons. Lower-case alphabet recognition or letter sounds was not included in the total score for English or Spanish. Score range for English was 0 to 73 and for Spanish was 0 to 94, with higher score indicating better outcome
Measured: Baseline and month 9
Change in caregiver involvement measured by the Parent Child Interactivity Scale (PCI)
The Parent Child Interactivity Scale (PCI) uses parent self-assessment and a four-point Likert scale for five items assessing reading, such as "Looked at pictures together in a book", and ten items assessing other literacy activities, such as "Practiced rhyming words". We calculated scores for reading (PCI Read), for other activities (PCI Activities), and a composite score was calculated (PCI Total). Items ranged from 0 to 3 for 15 items, thus score ranged from 0 to 45, with higher score indicating better outcome.
Measured: Baseline and month 9

Secondary outcomes (1)

Change in parent trust in pediatricians using Wake Forest Physician Trust Scale
Physician trust is measured by the sum of the 10 item scores (reverse-scored for negative items), ranging from 10 to 50, with a higher score indicating more trust.
Measured: Baseline and month 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 201726 Jul 2019

First posted12 Feb 2021
Study start16 Oct 2017
Primary completion26 Jul 2019
Study completion26 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for LiteracyStudies of the same condition, open and under way.
More trials run by Stanford 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: 381 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04752943
Sponsor's protocol ID: 42320
Status last verified: Mar 2021
First submitted: 2 Feb 2021
Last updated: 29 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Doss C, Fahle EM, Loeb S, York BN. More Than Just a Nudge Supporting Kindergarten Parents with Differentiated and Personalized Text Messages. Journal of Human Resources. 2019;54(3):567-603
Invernizzi M, Sullivan A, Meier J, Swank L. Phonological awareness literacy screening (PALS) PreK. . Richmond, VA: University of Virginia. 2004.
York BN, Loeb, S., & Doss, C. One Step at a Time: The Effects of an Early Literacy Text-Messaging Program for Parents of Preschoolers Journal of Human Resources 54(3), 537-566. 2019.
Chamberlain LJ, Bruce J, De La Cruz M, Huffman L, Steinberg JR, Bruguera R, Peterson JW, Gardner RM, He Z, Ordaz Y, Connelly E, Loeb S. A Text-Based Intervention to Promote Literacy: An RCT. Pediatrics. 2021 Oct;148(4):e2020049648. doi: 10.1542/peds.2020-049648. Epub 2021 Sep 20.
PubMed 34544847

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Literacy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tips By Text: Using Text Messages to Support Clinic Parents and Improve Child School Readiness Outcomes
ClinicalTrials.gov ID: NCT04752943
Acronym / sponsor ID: 42320
Conditions: Literacy
Keywords: school readiness
Study type: Interventional
Recruitment status: Completed
Enrolment: 381 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Santa Clara Valley Medical Center
Study start: 16 Oct 2017 (actual)
Primary completion: 26 Jul 2019 (actual)
Study completion: 26 Jul 2019 (actual)
First posted: 12 Feb 2021 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Children and caregivers receiving TipsByText messages	Experimental	Other: Tips By Text Messages
Children and caregivers not receiving TipsByText texts	No intervention	–

Who may qualify

Ages: 3 to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Parents of participants must be last least 18 years of age.
Parents must be English and Spanish speaking, as the Tips by Text texting platform is currently in those languages.
Child must be 3-5 years old at the time of their clinic visit.

Key exclusion criteria (4 listed)

Parent does not speak English or Spanish. This applies given that the texting intervention has the capacity to be conducted in these two languages.
Parent does not have cell phone that would allow texting.
For the literacy texting intervention, the child must NOT be enrolled in Head Start,Transitional Kindergarten or other subsidized preschool. Parents will be provided with a list of preschools that would warrant exclusion. Childcare is ok. For the trust and no-show evaluation arm, participants may be enrolled in any form of early childhood education.
Child is currently receiving services for delay (speech, motor, or cognitive). If the child briefly received services for delays over a year before start date of the study, they are still eligible.

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
Tips By Text MessagesTexts sent to caregivers meant to increase parent child interaction around literacy, sent to participants 3 x a week for 7 months	Other	Children and caregivers receiving TipsByText messages

Primary outcome

Change in child literacy measured by the Phonological Awareness Literacy Screening Tool (PALS-PreK) Score
Time frame: Baseline and month 9
The PALS-PreK measures preschoolers' knowledge of literacy fundamentals: name writing, alphabet knowledge, sound awareness, print and word awareness, rhyme awareness, and nursery rhyme awareness. The English and Spanish PALS-PreK versions slightly differ in content, thus we standardized composite scores for both the pre and post score by language to allow fair comparisons. Lower-case alphabet recognition or letter sounds was not included in the total score for English or Spanish. Score range for English was 0 to 73 and for Spanish was 0 to 94, with higher score indicating better outcome
Change in caregiver involvement measured by the Parent Child Interactivity Scale (PCI)
Time frame: Baseline and month 9
The Parent Child Interactivity Scale (PCI) uses parent self-assessment and a four-point Likert scale for five items assessing reading, such as "Looked at pictures together in a book", and ten items assessing other literacy activities, such as "Practiced rhyming words". We calculated scores for reading (PCI Read), for other activities (PCI Activities), and a composite score was calculated (PCI Total). Items ranged from 0 to 3 for 15 items, thus score ranged from 0 to 45, with higher score indicating better outcome.

1 secondary outcome

Change in parent trust in pediatricians using Wake Forest Physician Trust Scale
Time frame: Baseline and month 9

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 29 Mar 2021.
BackgroundDoss C, Fahle EM, Loeb S, York BN. More Than Just a Nudge Supporting Kindergarten Parents with Differentiated and Personalized Text Messages. Journal of Human Resources. 2019;54(3):567-603
BackgroundInvernizzi M, Sullivan A, Meier J, Swank L. Phonological awareness literacy screening (PALS) PreK. . Richmond, VA: University of Virginia. 2004.
BackgroundYork BN, Loeb, S., & Doss, C. One Step at a Time: The Effects of an Early Literacy Text-Messaging Program for Parents of Preschoolers Journal of Human Resources 54(3), 537-566. 2019.
Derived from this study: PubMed 34544847Chamberlain LJ, Bruce J, De La Cruz M, Huffman L, Steinberg JR, Bruguera R, Peterson JW, Gardner RM, He Z, Ordaz Y, Connelly E, Loeb S. A Text-Based Intervention to Promote Literacy: An RCT. Pediatrics. 2021 Oct;148(4):e2020049648. doi: 10.1542/peds.2020-049648. Epub 2021 Sep 20.
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.

Lisa J Chamberlain, MD, MPH principal investigator

Stanford University

Janine Bruce, MPH, DrPH study director

Stanford University

Susanna Loeb, PhD study director

Brown 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 Tips By Text Messages in people with Literacy, run by Stanford 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 3 inclusion and 4 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 29 Mar 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 child literacy measured by the Phonological Awareness Literacy Screening Tool (PALS-PreK) Score (time frame: Baseline and month 9). The study lists 2 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 NCT04752943, which also lists 4 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 29 Mar 2021.