Self-Concept Reinforcement for Early School Readiness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorChildren's Hospital Los Angeles
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Self-Concept Reinforcement for Early School Readiness
BehavioralSelf-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
BehavioralROR provides children's books and brief book-sharing advice at pediatric well child visits
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 2 interventions
Group B: Treatment-As-Usual Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 15 months post-enrollment2
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.
Time frame
Baseline to 15 months post-enrollmentSecondary outcomes
1
Mean change from baseline for Child Early Language Skills using the Receptive One-Word Picture Vocabulary Test.
Receptive One-Word Picture Vocabulary Test (ROWPVT.) Respondents select 1 picture among 4 that best represents the word spoken by the examiner; this repeats until a set number of consecutive errors. Therefore, higher score suggests better literacy.
Time frame
Baseline to 15 months post-enrollment2
Mean change from baseline for Child Early Literacy Skills using the The Reading House for participants 3-5 years old.
The Reading House uses a children's book to screen for emergent literacy skills. The assessor shares the book with the child and screens skills using a 9-item, scripted scoring form.
Time frame
Baseline to 15 months post-enrollment3
Mean change from baseline for Bookreading Quantity Subdimension using STIMQ 2-READ Scale
STIMQ 2-READ Scale. Book-sharing scale (scale to assess ways caregiver shares books with child). 12-35 months old: minimum/maximum scores are 0 to 9. 36 months and older: minimum/maximum scores are 0 to 9. Higher scores indicate more book-reading behaviors.
Time frame
Baseline to 15 months post-enrollment4
Mean change from baseline for Diversity of Content/Concepts using STIMQ 2-READ Scale.
STIMQ 2-READ Scale. Book-sharing scale (scale to assess ways caregiver shares books with child). 12-35 months old: minimum/maximum scores are 0 to 6. 36 months and older: minimum/maximum scores are 0 to 8. Higher scores indicate more book-reading behaviors.
Time frame
Baseline to 15 months post-enrollmentOther outcomes
1
Book-sharing beliefs
Parental Reading Belief Inventory (PRBI)
Time frame
0 and 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Los Angeles
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov