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Completed

NCT Number: NCT04752943

Leveraging Clinic to Promote Literacy in Young Children

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.

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Key information

Conditions

Literacy Behavior Communication

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valley Medical Center

San Jose, California, 95128, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tips By Text Messages

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Santa Clara Valley Medical Center

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2021
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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