Recruiting

SCR4ESR

Sponsor:

Children's Hospital Los Angeles

Code:

NCT06084910

Conditions

Child Behavior

Child Behavior Problem

Child Behavior Disorders

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

Self-Concept Reinforcement for Early School Readiness

Reach Out and Read

Study Details

Brief 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.

Conditions

Child Behavior

Child Behavior Problem

Child Behavior Disorders

Study ID

NCT06084910

Start date

Jul 3, 2024

Status verified date

Dec, 2025

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Parent/Legal guardian must be 18 years old or older
  • Speak English
  • Legal guardian of the index 2 to 4-year-old African American child

Exclusion Criteria:

  • Index child has severe cognitive impairment or communication difficulties (i.e., severe intellectual disability or nonverbal)
  • Plan to move outside of the Children's Hospital Los Angeles (CHLA) service area in the next 15 months
  • CHLA employee
  • Participated in Aim 1 interviews

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Self-Concept Reinforcement for Early School Readiness

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

ROR provides children's books and brief book-sharing advice at pediatric well child visits

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

Central Contacts and Locations

Central contacts

Ashaunta T Anderson, MD, MPH, MSHS

(323) 669-2113asanderson@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Ashaunta T Anderson, MD, MPH

(323) 361-7202asanderson@chla.usc.edu

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • Child Behavior
  • Literacy
  • Early Childhood
  • Parenting
  • Self-Concept

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2025-12-16.