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Leveraging Clinic to Promote Literacy in Young Children

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ClinicalTrials.gov Identifier: NCT04752943
Recruitment Status : Completed
First Posted : February 12, 2021
Last Update Posted : March 29, 2021
Sponsor:
Collaborator:
Santa Clara Valley Medical Center
Information provided by (Responsible Party):
Lisa Chamberlain, Stanford University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Literacy Other: Tips By Text Messages Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tips By Text: Using Text Messages to Support Clinic Parents and Improve Child School Readiness Outcomes
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : July 26, 2019
Actual Study Completion Date : July 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arms and Interventions
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Arm Intervention/treatment
Experimental: Children and caregivers receiving TipsByText messages Other: Tips By Text Messages
Texts sent to caregivers meant to increase parent child interaction around literacy, sent to participants 3 x a week for 7 months
No Intervention: Children and caregivers not receiving TipsByText texts


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Change in parent trust in pediatricians using Wake Forest Physician Trust Scale [ Time Frame: Baseline and month 9 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752943


Locations
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United States, California
Valley Medical Center
San Jose, California, United States, 95128
Sponsors and Collaborators
Stanford University
Santa Clara Valley Medical Center
Investigators
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Principal Investigator: Lisa J Chamberlain, MD, MPH Stanford University
Study Director: Janine Bruce, MPH, DrPH Stanford University
Study Director: Susanna Loeb, PhD Brown University
More Information
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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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lisa Chamberlain, Professor of Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT04752943    
Other Study ID Numbers: 42320
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Chamberlain, Stanford University:
school readiness