Clinical trial NCT05884541: Promoting Math in Young Children: Leveraging Pediatric Clinics to Reach Underrepresented Children in Rural Communities
Official title: Promoting Math in Young Children: Leveraging Pediatric Clinics to Reach Underrepresented Children in Rural Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Math Learning
Keywords: early math learning
preschool
rural
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2023-06-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 36
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in child early math skills measured by the Research-based Early Math Assessment (REMA-Brief)
timeFrame: baseline and month 9
Secondary outcomes:
measure: Change in child literacy measured by the Phonological Awareness Literacy Screening Tools (PALS-PreK) Score
timeFrame: baseline and month 9
measure: Change in parent confidence teaching math and literacy by the Development and Research in Early Math Education (DREME)
timeFrame: baseline and month 9
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Rural Practice Research Network
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jaime W Peterson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Lisa Chamberlain, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Susanna Loeb, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Kendall Dunlop-Korsness, MPH
role: STUDY_DIRECTOR
affiliation: Oregon Health and Science University
name: LeAnn Michaels, BS
role: STUDY_DIRECTOR
References: