- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07677618
A Kinder Coaching Program With Community Health Workers "READY" (READY)
Promoting School Readiness in Primary Care: A Kinder Coaching Program With Community Health Workers
Study Overview
Status
Intervention / Treatment
Detailed Description
Children who enter school ready to learn are more likely to succeed academically. Yet, children from low income households often enter school behind their high income peers. The primary care clinic has an opportunity to promote school readiness (SR), as pediatricians have trusted, repeated relationships with children and families. In prior work, families of recent kindergarteners identified specific SR interventions for pediatric clinics to increase parent SR knowledge through Checklists and parent empowerment through Coaching with community health workers.
The research objective of this R01 is to assess the effectiveness of a high touch, Kinder Coaching Program, compared to enhanced usual well child care (eUC) [an SR Checklist reviewed by provider] on child SR in primary care clinics serving Medicaid families with preschoolers. The premise is that pediatric clinics are trusted, acceptable, and feasible settings to identify and address SR needs of families. The investigators will conduct a Type 1 hybrid effectiveness-implementation randomized controlled trial on Kinder Coaching with parents of 3-4 year olds in 2 safety-net primary care clinics serving families on Medicaid in Oregon (n=240; 120/arm) powered with pilot data to assess primary efficacy outcomes: child school readiness (Brigance III) and child social emotional development (DECA). Secondary parent outcomes (school readiness behaviors, confidence, resources, barriers) and implementation outcomes (e.g., delivery, fidelity, cost-benefit analysis) using the RE-AIM implementation framework.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jaime Peterson, MD, MPH
- Phone Number: 503-418-5700
- Email: peterjai@ohsu.edu
Study Locations
-
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Oregon
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Hillsboro, Oregon, United States, 97123
- Hillsboro Pediatric Clinic
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Contact:
- Clinic Manager
- Phone Number: 503-640-2757
- Email: lhickey@hillsboropediatrics.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent or caregiver is 18 years of age or older with no intellectual disability and can speak and understand Spanish and/or English. Participants unable to read will be eligible as data will be verbally collected by bilingual research staff.
- Child is between 3 and 4 years of age at enrollment and receives primary care at a study site.
- Child is from a low-income household on Medicaid insurance.
- Child has no significant developmental disability or serious medical condition that limits communication with the Kinder Coach. Children with mild developmental delays including speech delay, gross motor delay, autism spectrum disorder, mild cerebral palsy, and ADHD will be included to capture a heterogenous, real-world sample from primary care.
Exclusion Criteria:
- Parent or child with significant intellectual disability.
- Teen parents under the age of 18.
- Child is in foster care or other situation in which consent cannot be obtained from a legal guardian.
- Child with a significant developmental disability that limits participation including cerebral palsy, non-verbal autism spectrum disorder, Down's syndrome, global developmental delay, or other serious medical condition impacting ability to participate in a Kinder Coaching visit. Developmental conditions will be defined as children who screen negative on the Children with Special Health Care Needs (CSHCN) screener for developmental and/or behavioral special needs "above and beyond what would be expected" for a child of that age.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Enhanced Usual Care - School Readiness Checklist
Provider reviews a school readiness checklist with tips in the well child check
|
|
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Experimental: Intervention - Kinder Coaching
The Kinder Ready Coaching Intervention provides two structured, individualized parent-child school readiness coaching sessions with a bilingual community health worker (CHW) to: 1) share knowledge of kindergarten skills, 2) assess child school readiness, 3) set goals and model activities for home practice, 4) connect families to critical school readiness resources including preschool and behavioral health, and 5) provide educational tools for home such as culturally concordant books, games, and/or puzzles.
|
The Kinder Ready Coaching Intervention provides two structured, individualized parent-child school readiness coaching sessions with a bilingual community health worker (CHW) to: 1) share knowledge of kindergarten skills, 2) assess child school readiness, 3) set goals and model activities for home practice, 4) connect families to critical school readiness resources including preschool and behavioral health, and 5) provide educational tools for home such as culturally concordant books, games, and/or puzzles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child composite school readiness skills
Time Frame: Baseline and 12 months post-intervention
|
Brigance III Screen (Brigance); total composite score: min 0, max 0. Interpretation: Very weak (< 70), Weak (70-79), Below average (80-89), Average (90-110), Above average (111-120), Strong (121-130), Very strong (>130)
|
Baseline and 12 months post-intervention
|
|
Child social emotional development
Time Frame: Baseline and 12 months post-intervention
|
Devereux Early Childhood Assessment (DECA). Attachment relationship T score: Min 28- Max 72 Initiative T score: Min 28- Max 72 Self-regulation T score: Min 28- Max 72 Behavioral concerns T score: Min 28- Max 72 Total Protective Factors sum: Description total protective factors: Strengths, Typical, Area of Need Description behavioral concerns: Strengths, Typical, Area of Need |
Baseline and 12 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of children enrolled in preschool by intervention status
Time Frame: Baseline and 12 months post-intervention
|
Child preschool enrollment will be determined by parent report at two time points.
Parents will be asked "is your child enrolled in preschool", yes or no.
|
Baseline and 12 months post-intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jaime Peterson, MD, MPH, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00030113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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