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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Early Math Learning

Intervention / Treatment
-----------------
* Other: TipsbyText Messages


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 36 Months
Maximum Age: 59 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Children and parents receiving Early Math Texts (TipsbyText) | Other: TipsbyText Messages<br>* Texts sent to caregivers meant to increase parent child interaction around math and literacy, sent to participants 4x a week for 8 months<br>|
| No Intervention: Control<br>Children and parents not receiving Early Math Texts (TipsbyText) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and month 9 | 
| 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. | baseline and month 9 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early math learning, preschool, rural