- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06390215
Clinic-Based School Readiness Coaching
April 30, 2024 updated by: Jaime Peterson, Oregon Health and Science University
The School Readiness Journey: Capturing the Unheard Voices of Latino Parents
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jaime Peterson, MD, MPH
- Phone Number: 575-770-8500
- Email: peterjai@ohsu.edu
Study Contact Backup
- Name: Maya Postigo, BA
- Phone Number: 3602713846
- Email: postigo@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University
-
Contact:
- Jaime Peterson, MD, MPH
- Phone Number: 575-770-8500
- Email: peterjai@ohsu.edu
-
Contact:
- Maya Postigo, BA
- Phone Number: 360-271-3846
- Email: postigo@ohsu.edu
-
Principal Investigator:
- Jaime Peterson, MD, MPH
-
Sub-Investigator:
- Katharine Zuckerman, MD, MPH
-
Sub-Investigator:
- Ellen Stevenson, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: School Readiness Coaching Intervention
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.
|
Two 1-hr School Readiness Coaching Session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in child's school readiness skills measured by the Brigance Early Childhood Screen III for 3-5-year-olds.
Time Frame: Baseline and month 3
|
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
Time Frame: Baseline and month 3
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in rates of well-child checks at the pediatric clinic.
Time Frame: Year one and year two
|
Clinic will generate well-child checks reports for children enrolled to compare to clinic average.
|
Year one and year two
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jaime Peterson, MD, MPH, Oregon Health and Science University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Estimated)
March 31, 2025
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
April 25, 2024
First Submitted That Met QC Criteria
April 25, 2024
First Posted (Actual)
April 30, 2024
Study Record Updates
Last Update Posted (Actual)
May 2, 2024
Last Update Submitted That Met QC Criteria
April 30, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00021040
- PPQ#1023820 (Other Grant/Funding Number: OHSU Health IDS, LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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