Peer-reviewed article
Randomized single-blind study to examine the implementation and effectiveness of integrating evidence-based early relational health programs in pediatrics for families with low incomes: A clinical trial protocol.
Canfield CF, Miller EB ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study tests whether combining two early childhood programs (HealthySteps and PlayReadVIP) improves outcomes for low-income families better than HealthySteps alone. The research will follow 320 parent-child pairs from birth to age 2, with regular check-ups at pediatric visits. The study measures whether the combined approach strengthens parent-child relationships, increases how parents stimulate their children's thinking, and improves children's emotional development.
Key points
- The intervention targets disparities in early childhood development caused by poverty
- Two evidence-based programs (HealthySteps and PlayReadVIP) are being combined to meet diverse family needs
- The study includes 320 families in the effectiveness phase, with assessments at enrollment and at 12 and 24 months
- Primary outcomes focus on parent-child relationships, cognitive stimulation, and child socioemotional development
- The design uses a randomized controlled trial comparing the combined intervention to HealthySteps alone
Limitations
This is a protocol document describing a planned study, not results, so it cannot tell us whether the intervention actually works or what the outcomes were. The study is based in a high-income country setting and may not reflect implementation in other contexts.
Abstract
Disparities in early childhood development due to poverty are linked to lifelong gaps in health and well-being. To address such disparities, interventions must not only include the prevention of toxic stress, but also the promotion of early relational health-that is the presence of safe, stable, nurturing relationships between young children and their caregivers. Moreover, a public health approach that integrates multiple programs in order to meet the unique needs and build on the varied resources of individual families is needed to effect population-level change. This randomized controlled trial seeks to examine the implementation and effectiveness of combining two evidence-based interventions, HealthySteps and PlayReadVIP. A total of 355 parent-child dyads, 35 in the implementation phase and 320 in the effectiveness phase, will be randomly assigned to receive HealthySteps+PlayReadVIP or traditional HealthySteps, as an active Control. Families will receive the intervention at each pediatric well-child visit from birth to age 2 and will complete assessments at enrollment and child age 12 and 24 months. In addition, up to ten HealthySteps Specialists and other care providers will be enrolled and will complete surveys at each assessment point. The primary outcomes include positive parent-child relationship, parent cognitive stimulation, and child socioemotional development.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Integration of HealthySteps and PlayReadVIP programs delivered at pediatric well-child visits from birth to age 2, focused on promoting early relational health through safe, stable, nurturing relationships between children and caregivers
- Population
- Parent-child dyads from low-income families (320 in effectiveness phase), with HealthySteps Specialists and care providers also enrolled
Key finding
Study protocol includes 355 parent-child dyads total (35 implementation phase, 320 effectiveness phase)
CF et al. · Europe PMC · 24 Jul 2026