School ReadinessREADYNCT07677618
A Kinder Coaching Program With Community Health Workers "READY"
A study testing Kinder Coaching in people with School Readiness and Preschool Enrollment, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- School Readiness, Preschool Enrollment, Parent School Readiness Confidence
- What is being tested?
- Kinder Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 1 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hillsboro Pediatric Clinic
Hillsboro, Oregon, 97123
Clinic Manager, 503-640-2757, lhickey@hillsboropediatrics.com
About this study
Official title: Promoting School Readiness in Primary Care: A Kinder Coaching Program With Community Health Workers
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.
Read the 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.
- Being tested
- Kinder Coaching
- Keywords
- school readiness, Kinder Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinder CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Kinder Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Baseline and 12 months post-intervention
Secondary outcomes (1)
Percentage of children enrolled in preschool by intervention status
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.
Measured: Baseline and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2027 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School ReadinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jaime Peterson, Oregon Health and Science University
- Investigators
- Jaime Peterson, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677618
- Sponsor's protocol ID
- STUDY00030113
- Acronym
- READY
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be stored within NICHD DASH repository. Investigators can request access through DASH policies and procedures.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting School Readiness in Primary Care: A Kinder Coaching Program With Community Health Workers
- ClinicalTrials.gov ID
- NCT07677618
- Acronym / sponsor ID
- READY / STUDY00030113
- Keywords
- school readiness, Kinder Coaching
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Kinder CoachingThe 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinder CoachingThe 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. | Behavioural | Intervention - Kinder Coaching |
Primary outcome
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)
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
1 secondary outcome
Percentage of children enrolled in preschool by intervention status
Time frame: Baseline and 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be stored within NICHD DASH repository. Investigators can request access through DASH policies and procedures.
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CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaime Peterson, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinder Coaching in people with School Readiness and Preschool Enrollment, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaime Peterson, MD, MPH (503-418-5700, peterjai@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child composite school readiness skills (time frame: Baseline and 12 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.