Self-Concept Reinforcement for Early School Readiness

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT06084910
Status
Recruiting
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Conditions

  • Child Behavior
  • Child Behavior Disorders
  • Child Behavior Problem

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Self-Concept Reinforcement for Early School Readiness — BEHAVIORAL
    Self-Concept Reinforcement for Early School Readiness (SCR4ESR) is based on the nationwide Reach Out and Read (ROR) program adapted to reinforce self-concept. ROR provides children's books, brief book-sharing advice, and developmental surveillance at pediatric well child visits. Each of the 5 SCR4ESR sessions provides 1 children's book with a self-concept theme, 1 parent handout, and modeling of book-sharing.
  • Reach Out and Read — BEHAVIORAL
    ROR provides children's books and brief book-sharing advice at pediatric well child visits

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
Dec 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental Group
    Caregiver-child dyads that receive the Self-Concept Reinforcement for Early School Readiness (SCR4ESR) intervention
  • Active Comparator: Treatment-As-Usual Control Group
    Caregiver-child dyads that receive standard Reach Out and Read intervention without additional emphasis on self-concept

Primary Outcome Measure

Mean change from baseline for externalizing behavior score for Child Behavioral Health as measured by Child Behavior Checklist [ Time Frame: Baseline to 15 months post-enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Ashaunta T Anderson, MD, MPH
[email protected]
(323) 361-7202

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Children's Hospital Los Angeles· Los Angeles, CA

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