NCT07677618

Brief Summary

In this study, the investigators compare two novel primary care interventions (School Readiness Checklist vs. Kinder Coaching) for low-income parents, which were co-developed by parent, clinical, and educational stakeholders. This R01 builds evidence on a low touch (low intensity, lower cost intervention) School Readiness Checklist compared to high touch (higher intensity, embedded program) Kinder Coaching with Community Health Workers in a hybrid effectiveness-implementation RCT.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Jul 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

May 22, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

May 22, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

school readinessKinder Coaching

Outcome Measures

Primary Outcomes (2)

  • Child composite school readiness skills

    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

    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 Outcomes (1)

  • Percentage of children enrolled in preschool by intervention status

    Baseline and 12 months post-intervention

Study Arms (2)

Enhanced Usual Care - School Readiness Checklist

NO INTERVENTION

Provider reviews a school readiness checklist with tips in the well child check

Intervention - Kinder Coaching

EXPERIMENTAL

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.

Behavioral: Kinder Coaching

Interventions

Kinder CoachingBEHAVIORAL

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.

Intervention - Kinder Coaching

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillsboro Pediatric Clinic

Hillsboro, Oregon, 97123, United States

Location

Study Officials

  • Jaime Peterson, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime Peterson, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The research assistant performing baseline and follow up outcome measures will be masked to group assignment. The PI and study team will be masked. Only the project coordinator will be unmasked as they will assign randomization.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2026

First Posted

July 1, 2026

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2031

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Deidentified data will be stored within NICHD DASH repository. Investigators can request access through DASH policies and procedures.

Time Frame
De-identified quantitative and qualitative data will be made available at the time of publication of primary study findings or at the end of the funding period, whichever comes first.
Access Criteria
Researchers interested in accessing de-identified quantitative and qualitative data must request the data from DASH using their policies and procedures.
More information

Locations