NCT06390215

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
May 2023Jun 2026

Study Start

First participant enrolled

May 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

April 25, 2024

Last Update Submit

April 30, 2024

Conditions

Keywords

School ReadinessKindergartenEarly LearningCoaching

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Change in rates of well-child checks at the pediatric clinic.

    Year one and year two

Study Arms (1)

School Readiness Coaching Intervention

EXPERIMENTAL

Two 1-hr individualized parent-child School Readiness Coaching Sessions conducted with Community Health Worker to assess child and parent school readiness skills and behaviors and provide parents with modeling, tools, and resources to support parent early math and literacy skills for home practice and connect them to preschool and community resources.

Behavioral: School Readiness Coaching Intervention

Interventions

Two 1-hr School Readiness Coaching Session

School Readiness Coaching Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Child is too ill to participate
  • Parents who are unable to complete study activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Study Officials

  • Jaime Peterson, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime Peterson, MD, MPH

CONTACT

Maya Postigo, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 30, 2024

Study Start

May 1, 2023

Primary Completion

March 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations