Self-Concept Reinforcement for Early School Readiness

NCT06084910 | Recruiting DMC

• 2 other identifiers: CHLA-23-002791K23MD016944-01A1
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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. 1.assess the feasibility and acceptability of SCR4ESR implementation among parents and providers,
2. 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.

Conditions

Child Behavior; Child Behavior Problem; Child Behavior Disorders

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline for externalizing behavior score for Child Behavioral Health as measured by Child Behavior Checklist

  Child Behavior Checklist - Externalizing behaviors. Items rated on a Likert scale from 0 to 2. The items are divided across categories and summed by category such that higher sums amount to more behavioral problems. 2-3 years old: minimum/maximum scores 0 to 128. 4 years and older: minimum/maximum scores 0 to 236.

  Baseline to 15 months post-enrollment

• Mean change from baseline for internalizing behavior score for Child Behavioral Health as measured by Child Behavior Checklist

  Child Behavior Checklist - internalizing behaviors. Items rated on a Likert scale from 0 to 2. The items are divided across categories and summed by category such that higher sums amount to more behavioral problems. 2-3 years old: minimum/maximum scores 0 to 128. 4 years and older: minimum/maximum scores 0 to 236.

  Baseline to 15 months post-enrollment

Secondary Outcomes (6)

• Mean change from baseline for Child Early Language Skills using the Receptive One-Word Picture Vocabulary Test.

  Baseline to 15 months post-enrollment

• Mean change from baseline for Child Early Literacy Skills using the The Reading House for participants 3-5 years old.

  Baseline to 15 months post-enrollment

• Mean change from baseline for Bookreading Quantity Subdimension using STIMQ 2-READ Scale

  Baseline to 15 months post-enrollment

• Mean change from baseline for Diversity of Content/Concepts using STIMQ 2-READ Scale.

  Baseline to 15 months post-enrollment

• Mean change from baseline Bookreading Quality Subdimension using STIMQ 2-READ Scale.

  Baseline to 15 months post-enrollment

Other Outcomes (1)

• Book-sharing beliefs

  0 and 15 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Caregiver-child dyads that receive the Self-Concept Reinforcement for Early School Readiness (SCR4ESR) intervention

Behavioral: Self-Concept Reinforcement for Early School Readiness; Behavioral: Reach Out and Read

Treatment-As-Usual Control Group

ACTIVE COMPARATOR

Caregiver-child dyads that receive standard Reach Out and Read intervention without additional emphasis on self-concept

Behavioral: Reach Out and Read

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.

Also known as: SCR4ESR

Experimental Group

Reach Out and Read BEHAVIORAL

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

Also known as: ROR

Experimental Group; Treatment-As-Usual Control Group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Child Behavior; Child Behavior Disorders; Literacy

Condition Hierarchy (Ancestors)

Behavior; Neurodevelopmental Disorders; Mental Disorders; Communication

Study Officials

• Ashaunta T Anderson, MD, MPH, MSHS

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashaunta T Anderson, MD, MPH, MSHS

CONTACT

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

Michele D Kipke, PhD

CONTACT

(323) 361-8424; mkipke@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 16, 2023
• Study Start: July 3, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)