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RecruitingNCT05884541MATHUpdated Nov 1, 2023

Promoting Math in Young Children: Leveraging Pediatric Clinics to Reach Underrepresented Children in Rural Communities

An interventional study of TipsbyText Messages in Early Math Learning, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 36 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
36 Months to 59 Months
Sex
All
01

Study summary

The goals of this clinical trial to examine how pediatricians prescribing early math enriching texts to the parents of their patients affects the early math skills of under-resourced pre-kindergarten-aged children in rural Oregon. The main question it aims to answer is: What is the impact of the text intervention on early math skills in preschool-aged children? Participants will be randomized to receive the early math text intervention or standard of care. Researchers will compare pre-and-post math performance between the intervention and control group.

Read the detailed description

The goals of this clinical trial to examine how pediatricians prescribing early math enriching texts (TipsbyText) to parents of 3-4 year olds affects the math skills of under-resourced pre-kindergarten-aged children in rural Oregon. The main question it aims to answer is: What is the impact of the text intervention on early math skills in preschool-aged children using the Research-based Early Math Assessment (REMA-Brief)? Two secondary questions of the study are: What is the impact on child literacy using the Phonological Awareness Literacy Screening Tool (PALS-PreK) and parent confidence using the Development and Research in Early Math Education (DREME)? Participants will be randomized to receive intervention (the early math text intervention) or control (no texts). Researchers will compare pre-and-post math performance on the REMA-Brief (primary outcome), PALS-PreK (secondary child outcome) and DREME (secondary parent outcome) between the intervention and control group.

02

Conditions studied

  • Early Math Learning

Keywords

  • early math learning
  • preschool
  • rural
03

In context

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
36 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Parents of participants must be at least 18 years of age
  • Child must be 3 or 4 years old at the time of screening
  • Child receives care at a participating Oregon Rural Practice-based Research Network (ORPRN) clinic
  • Parent and child can communicate in English or Spanish
  • Parent is able to give informed consent
  • Child is eligible for Medicaid services

Exclusion criteria

Exclusion Criteria:

  • Parent is not able to receive text messages
  • Parent is not able to read text messages
  • Child is too ill to participate
  • Parents who are unable to complete study activities
  • Child has a sibling currently enrolled in the study
  • Child has a developmental delay including neurodevelopmental disorders such as autism or syndromes associated with developmental delay (e.g. cerebral palsy, seizure disorders, attention deficit / hyperactivity disorder). Isolated expressive speech delay is not a developmental exclusion criteria.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Intervention

    Children and parents receiving Early Math Texts (TipsbyText)

    Other: TipsbyText Messages

  • No intervention
    Control

    Children and parents not receiving Early Math Texts (TipsbyText)

Interventions

  • OtherTipsbyText Messages

    Texts sent to caregivers meant to increase parent child interaction around math and literacy, sent to participants 4x a week for 8 months

06

What researchers measure

Primary outcomes

  1. Change in child early math skills measured by the Research-based Early Math Assessment (REMA-Brief)

    The Research-based Early Math Assessment (REMA-Brief) REMA-Brief assesses core mathematical abilities of children in PK and Transitional Kindergarten (TK) using an individual interview format, with explicit protocol and scoring procedures. Abilities are assessed according to theoretically and empirically based developmental progressions that underlie mathematical learning trajectories. The REMA Brief is a content-referenced test, built on psychological development that includes normative interpretations. There are twenty items; with a maximum possible raw score is 28. Average T score is 50. Standard deviation is 7.

    Time frame: baseline and month 9

Secondary outcomes

  1. Change in child literacy measured by the Phonological Awareness Literacy Screening Tools (PALS-PreK) Score

    Screening Tool (PALS-PreK) Score \[ Time Frame: Baseline and month 9 \] a. 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, investigators used the "name writing, alphabet knowledge, beginning sound awareness and nursery rhyme awareness" and each section will be scored separately. Name writing (max 7 points), alphabet knowledge (part A: 26 max; part B 26 max), beginning sound awareness (10 point max), print and word awareness (10 point max). Composite score range is 0-76 with higher score indicating a better outcome.

    Time frame: baseline and month 9

  2. Change in parent confidence teaching math and literacy by the Development and Research in Early Math Education (DREME)

    The DREME is a 17-item parent survey to assess parent confidence and beliefs regarding teaching and practicing math with their child.

    Time frame: baseline and month 9

07

Study locations

1 of 1 sites recruiting
  • Oregon Rural Practice Research Network
    Portland, Oregon 97239, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05884541
Lead sponsor
Oregon Health and Science University
Collaborators
Stanford University
Responsible party
Sponsor
First posted
Jun 1, 2023
Start date
Aug 1, 2023
Primary completion
Sep 30, 2024 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Nov 1, 2023

Study contacts

Jaime w Peterson, MD, MPH
Contact
peterjai@ohsu.edu
5034941049
LeAnn Michaels
Contact
michaell@ohsu.edu
Jaime W Peterson, MD, MPH
principal investigator · Oregon Health and Science University
Lisa Chamberlain, MD, MPH
principal investigator · Stanford University
Susanna Loeb, PhD
principal investigator · Stanford University
Kendall Dunlop-Korsness, MPH
study director · Oregon Health and Science University
LeAnn Michaels, BS
study director · Oregon Health and Science University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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