[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07677618":3,"trial-entities:NCT07677618":96,"trial-summary:NCT07677618":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":46,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":66,"locations":70,"central_contacts":86,"overall_officials":91,"references":94,"see_also_links":95},"NCT07677618","STUDY00030113","A Kinder Coaching Program With Community Health Workers \"READY\"","Promoting School Readiness in Primary Care: A Kinder Coaching Program With Community Health Workers","NOT_YET_RECRUITING","2031-07-01","2026-06","2026-07-01","2027-07-01","Oregon Health and Science University","OTHER",false,"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.","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.\n\nThe 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\u002Farm) 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.",[19,20,21],"School Readiness","Parent School Readiness Confidence and Skills","Preschool Enrollment",[23,24],"school readiness","Kinder Coaching","INTERVENTIONAL","PREVENTION",[28],"NA",{"count":30,"type":31},480,"ESTIMATED",[33],{"type":34,"name":24,"description":35,"armGroupLabels":36},"BEHAVIORAL","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\u002For puzzles.",[37],"Intervention - Kinder Coaching",[39,43],{"measure":40,"description":41,"timeFrame":42},"Child composite school readiness skills","Brigance III Screen (Brigance); total composite score: min 0, max 0. Interpretation: Very weak (\\\u003C 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",{"measure":44,"description":45,"timeFrame":42},"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\n\nTotal Protective Factors sum:\n\nDescription total protective factors: Strengths, Typical, Area of Need Description behavioral concerns: Strengths, Typical, Area of Need",[47],{"measure":48,"description":49,"timeFrame":42},"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.","ALL","2 Years",null,true,{"inclusion":55,"exclusion":60,"raw_text":65},[56,57,58,59],"Parent or caregiver is 18 years of age or older with no intellectual disability and can speak and understand Spanish and\u002For 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.",[61,62,63,64],"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\u002For behavioral special needs \"above and beyond what would be expected\" for a child of that age.","Inclusion Criteria:\n\n* Parent or caregiver is 18 years of age or older with no intellectual disability and can speak and understand Spanish and\u002For English. Participants unable to read will be eligible as data will be verbally collected by bilingual research staff.\n* Child is between 3 and 4 years of age at enrollment and receives primary care at a study site.\n* Child is from a low-income household on Medicaid insurance.\n* 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.\n\nExclusion Criteria:\n\n* Parent or child with significant intellectual disability.\n* Teen parents under the age of 18.\n* Child is in foster care or other situation in which consent cannot be obtained from a legal guardian.\n* 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\u002For behavioral special needs \"above and beyond what would be expected\" for a child of that age.",[67,68,69],"CHILD","ADULT","OLDER_ADULT",[71],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":83},"Hillsboro Pediatric Clinic","Hillsboro","Oregon","97123","United States",[78],{"name":79,"role":80,"phone":81,"email":82},"Clinic Manager","CONTACT","503-640-2757","lhickey@hillsboropediatrics.com",{"lat":84,"lon":85},45.52289,-122.98983,[87],{"name":88,"role":80,"phone":89,"email":90},"Jaime Peterson, MD, MPH","503-418-5700","peterjai@ohsu.edu",[92],{"name":88,"affiliation":13,"role":93},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":98},[24,20,21,19],[],{"nct_id":4,"found":53,"summary":100,"prompt_version":110},{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This study is an interventional trial comparing two different approaches: Kinder Coaching and a School Readiness Checklist. It plans to enroll 480 participants.","completed","Kinder Coaching Program for School Readiness","This study is testing two programs to help children from low-income families get ready for kindergarten. One program is called \"Kinder Coaching,\" where a bilingual community health worker (CHW) provides two personalized coaching sessions to parents about kindergarten skills and activities for home. The other program uses a \"School Readiness Checklist\" reviewed by a healthcare provider during regular check-ups. Researchers want to see if Kinder Coaching is more effective than the checklist in improving a child's school readiness and social-emotional development. You might be able to join if you are a parent or caregiver aged 18 or older, can speak English or Spanish, and have a child between 3 and 4 years old who receives care at a study site. The study aims to enroll 480 participants.","Your child's school readiness and social-emotional development will be measured 12 months after the intervention.",127,"If you participate, you would receive either two structured coaching sessions with a community health worker or have a school readiness checklist reviewed by your child's provider. Your child's school readiness and social-emotional development will be measured at the beginning and 12 months after the intervention.","Not stated in the trial record.",[24],"v2"]