NCT04752943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
381

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

February 2, 2021

Last Update Submit

March 25, 2021

Conditions

Keywords

school readiness

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Change in parent trust in pediatricians using Wake Forest Physician Trust Scale

    Baseline and month 9

Study Arms (2)

Children and caregivers receiving TipsByText messages

EXPERIMENTAL
Other: Tips By Text Messages

Children and caregivers not receiving TipsByText texts

NO INTERVENTION

Interventions

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

Children and caregivers receiving TipsByText messages

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valley Medical Center

San Jose, California, 95128, United States

Location

Related Publications (4)

  • 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

    BACKGROUND
  • Invernizzi M, Sullivan A, Meier J, Swank L. Phonological awareness literacy screening (PALS) PreK. . Richmond, VA: University of Virginia. 2004.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Lisa J Chamberlain, MD, MPH

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Janine Bruce, MPH, DrPH

    Stanford University

    STUDY DIRECTOR
  • Susanna Loeb, PhD

    Brown University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 12, 2021

Study Start

October 16, 2017

Primary Completion

July 26, 2019

Study Completion

July 26, 2019

Last Updated

March 29, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations