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

24 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

480

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Jaime Peterson, MD, MPH
  • Numéro de téléphone: 503-418-5700
  • E-mail: peterjai@ohsu.edu

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Enhanced Usual Care - School Readiness Checklist
Provider reviews a school readiness checklist with tips in the well child check
Expérimental: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Child composite school readiness skills
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of children enrolled in preschool by intervention status
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Oregon Health and Science University

Collaborateurs

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

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2027

Achèvement primaire (Estimé)

1 juillet 2030

Achèvement de l'étude (Estimé)

1 juillet 2031

Dates d'inscription aux études

Première soumission

22 mai 2026

Première soumission répondant aux critères de contrôle qualité

24 juin 2026

Première publication (Réel)

1 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • STUDY00030113

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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.

Critères d'accès au partage IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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