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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06390215
Other study ID # STUDY00021040
Secondary ID PPQ#1023820
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date June 30, 2026

Study information

Verified date April 2024
Source Oregon Health and Science University
Contact Jaime Peterson, MD, MPH
Phone 575-770-8500
Email peterjai@ohsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to examine how a clinic-based school readiness coaching session conducted by a community health worker for parents of 3-5-year-olds affects children's School Readiness (SR) skills and parents early SR knowledge and behaviors. The main questions it aims to answer are: What impact does the clinic-based coaching session have on preschool-aged children's school readiness skills and their parents' confidence in supporting and practicing early math and literacy behaviors at home? Participants will receive a 1-hr coaching session at their pediatric clinic and return after three months for a follow-up session. Researchers will compare pre-and-post child and parent SR outcomes between these two sessions.


Description:

The goal of this clinical trial is to examine how a clinic-based school readiness coaching session conducted by a community health worker for parents of 3-5-year-olds affects children's school readiness (SR) skills and parents early SR knowledge and behaviors. The main questions it aims to answer are: What impact does the clinic-based coaching session have on preschool-aged children's school readiness skills as measured by the Brigance Early Childhood Screen III? and What impact does the clinic-based coaching session have on parents' confidence in supporting and practicing early math and literacy behaviors at home using the DREME Parent Beliefs Survey? The secondary question this study aims to evaluate is: Does the 1-hr school readiness coaching session affect rates of well-child checks at the pediatric clinic? Participants will receive a 1-hr coaching session at their pediatric clinic and return after three months for a follow-up session. Researchers will compare pre-and-post Brigance scores for the child and pre-and post parent SR confidence DREME scores.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 30, 2026
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Receives primary care at one of 2 clinic sites - Parent or caregiver of 3-6-year-old - Child is eligible for Medicaid services - Parent and child can communicate in English or Spanish Exclusion Criteria: - Child is too ill to participate - Parents who are unable to complete study activities

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
School Readiness Coaching Intervention
Two 1-hr School Readiness Coaching Session

Locations

Country Name City State
United States Oregon Health and Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in child's school readiness skills measured by the Brigance Early Childhood Screen III for 3-5-year-olds. The Early Childhood Screens III, available in three age-specific volumes, evaluate the key predictors of school success across the domains of Physical Development, Language Development, Academic Skills/Cognitive Development, and Self-help and Social-Emotional Skills. Composite score range is 0-100 with higher score indicating a better outcome. Baseline and month 3
Primary Change in parent confidence teaching math and literacy measured by the DREME Parent Beliefs Survey The DREME Parent Beliefs Survey is composed of 6 items that assess parent confidence and beliefs regarding teaching and practicing math and literacy with their child. Baseline and month 3
Secondary Change in rates of well-child checks at the pediatric clinic. Clinic will generate well-child checks reports for children enrolled to compare to clinic average. Year one and year two
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