Clinical trial NCT04752943: Leveraging Clinic to Promote Literacy in Young Children
Official title: Tips By Text: Using Text Messages to Support Clinic Parents and Improve Child School Readiness Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Literacy
Keywords: school readiness
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Santa Clara Valley Medical Center
First posted: 2021-02-12
Enrollment: 381
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Change in child literacy measured by the Phonological Awareness Literacy Screening Tool (PALS-PreK) Score
timeFrame: Baseline and month 9
measure: Change in caregiver involvement measured by the Parent Child Interactivity Scale (PCI)
timeFrame: Baseline and month 9
Secondary outcomes:
measure: Change in parent trust in pediatricians using Wake Forest Physician Trust Scale
timeFrame: Baseline and month 9
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Valley Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Lisa J Chamberlain, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Janine Bruce, MPH, DrPH
role: STUDY_DIRECTOR
affiliation: Brown University
name: Susanna Loeb, PhD
role: STUDY_DIRECTOR
References:
citation: 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
citation: Invernizzi M, Sullivan A, Meier J, Swank L. Phonological awareness literacy screening (PALS) PreK. . Richmond, VA: University of Virginia. 2004.
citation: 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.
citation: 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.