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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04752943
Other study ID # 42320
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2017
Est. completion date July 26, 2019

Study information

Verified date March 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 381
Est. completion date July 26, 2019
Est. primary completion date July 26, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Valley Medical Center San Jose California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Santa Clara Valley Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline and month 9
Primary 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. Baseline and month 9
Secondary 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. Baseline and month 9
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