NCT06084910 Self-Concept Reinforcement for Early School Readiness
| NCT ID | NCT06084910 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Los Angeles |
| Condition | Child Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2024-07-03 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 134 participants in total. It began in 2024-07-03 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Ashaunta T Anderson, MD, MPH, MSHS
PRINCIPAL INVESTIGATOR
Children's Hospital Los Angeles
Frequently Asked Questions
Who can join the NCT06084910 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Child Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06084910 currently recruiting?
Yes, NCT06084910 is actively recruiting participants. Contact the research team at asanderson@chla.usc.edu for enrollment information.
Where is the NCT06084910 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06084910 clinical trial?
NCT06084910 is sponsored by Children's Hospital Los Angeles. The principal investigator is Ashaunta T Anderson, MD, MPH, MSHS at Children's Hospital Los Angeles. The trial plans to enroll 134 participants.