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A Kinder Coaching Program With Community Health Workers "READY" (READY)

24 juni 2026 bijgewerkt door: Jaime Peterson, Oregon Health and Science University

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

480

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Jaime Peterson, MD, MPH
  • Telefoonnummer: 503-418-5700
  • E-mail: peterjai@ohsu.edu

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Enhanced Usual Care - School Readiness Checklist
Provider reviews a school readiness checklist with tips in the well child check
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Child composite school readiness skills
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of children enrolled in preschool by intervention status
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Oregon Health and Science University

Medewerkers

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Onderzoekers

  • Hoofdonderzoeker: Jaime Peterson, MD, MPH, Oregon Health and Science University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2027

Primaire voltooiing (Geschat)

1 juli 2030

Studie voltooiing (Geschat)

1 juli 2031

Studieregistratiedata

Eerst ingediend

22 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 juni 2026

Eerst geplaatst (Werkelijk)

1 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • STUDY00030113

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

Researchers interested in accessing de-identified quantitative and qualitative data must request the data from DASH using their policies and procedures.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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