About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Kinder Coaching
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
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
Secondary outcomes
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.
Sponsors and contacts
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Oregon Health and Science University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
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