Clinical Trial

Self-Concept Reinforcement for Early School Readiness

Study acronym: SCR4ESR
Recruiting
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Summary
The goal of this pilot randomized controlled trial is to evaluate a self-concept intervention (Self-Concept Reinforcement for Early School Readiness (SCR4ESR)) in young African American children using experimental and mixed methods. SCR4ESR provides self-concept themed children's books and advice at health supervision visits of children enrolled at ages 2-4 years. The specific aims of the proposed project are to: 1. assess the feasibility and acceptability of SCR4ESR implementation among parents and providers, 2. evaluate the capacity of SCR4ESR to improve self-concept reinforcement and book-sharing behaviors in parents of young African American children, and 3) evaluate the capacity of SCR4ESR to improve behavioral health and literacy in young African American children. The interviews conducted in Aim 1 will guide refinement of the intervention tested in Aims 2 and 3. The qualitative assessment will be complemented by quantitative trial statistics (e.g., recruitment rate) that inform trial feasibility and acceptability. Finally, the mechanism by which SCR4ESR impacts the primary outcome, behavioral health, and the secondary outcome, literacy, will be evaluated by structural equation modeling. This project will inform the development and implementation of early childhood interventions that improve the health of African Americans.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-10-12; most recent amendment 2025-12-11.
Status change: Not Yet Recruiting → Recruiting 2025-12-11
Trial Details
NCT Number NCT06084910
Lead Sponsor Children's Hospital Los Angeles
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Conditions Child Behavior, Child Behavior Problem, Child Behavior Disorders
Enrollment 134 participants
Start Date 2024-07-03
Primary Completion 2028-11-30 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-16