NCT05140460

Brief Summary

Minority children disproportionately experience racial bias, which is linked to school failure, toxic stress, and health disparities. In contrast, a type of racial socialization called cultural pride reinforcement has been associated with positive academic, behavioral, and mental health outcomes. A clinic-based intervention to boost cultural pride may help parents foster resilience in their young children against the negative effects of racial bias. The investigators evaluated the extent to which a standard clinic-based early literacy program (Reach Out and Read (ROR)) and a similar program enhanced with cultural pride content (Cultural Pride Reinforcement for Early School Readiness (CPR4ESR)) are associated with improved cultural pride reinforcement practices, child development, family-provider communication, and health care utilization. Given the high representation of young children of color in the sample, the investigators hypothesized better outcomes among those who received the culturally tailored CPR4ESR program compared to those who received the standard ROR program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

November 8, 2021

Last Update Submit

November 18, 2021

Conditions

Keywords

Racial SocializationEthnic SocializationEarly ChildhoodLiteracyChild Development

Outcome Measures

Primary Outcomes (4)

  • 3-Month Change in Language Development

    3-month change in the percentage of child participants who achieved all age-appropriate language development milestones

    Baseline at enrollment to 3 months after enrollment

  • 3-Month Change in Social Development

    3-month change in the percentage of child participants who achieved all age-appropriate social development milestones

    Baseline at enrollment to 3 months after enrollment

  • 3-Month Change in Fine Motor Development

    3-month change in the percentage of child participants who achieved all age-appropriate fine motor development milestones

    Baseline at enrollment to 3 months after enrollment

  • 3-Month Change in Gross Motor Development

    3-month change in the percentage of child participants who achieved all age-appropriate gross motor development milestones

    Baseline at enrollment to 3 months after enrollment

Secondary Outcomes (6)

  • 3-Month Change in Family-Provider Communication

    Baseline at enrollment to 3 months after enrollment

  • 3-Month Change in Family-Provider Cultural Understanding

    Baseline at enrollment to 3 months after enrollment

  • 3-Month Change in Family-Provider Cultural Concordance

    Baseline at enrollment to 3 months after enrollment

  • Up-to-date Status of Well Child Visits

    12 months after study enrollment

  • Up-to-date Status of Vaccination

    12 months after study enrollment

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Cultural Pride Reinforcement for Early School Readiness (CPR4ESR)

Control

ACTIVE COMPARATOR
Behavioral: Reach Out and Read (ROR)

Interventions

The intervention entails distribution of a children's book with a cultural pride theme and the cultural pride parent book-sharing guide. Intervention participants select and receive a developmentally appropriate (baby, toddler, or preschool) book that features African American, Latino, Asian or diverse cultural pride perspectives.

Intervention

The control condition involves distribution of a standard ROR book and book-sharing advice. Distributed books are developmentally appropriate (baby, toddler, or preschool).

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Parent of at least 1 child 6 months to 5 years old
  • English-speaking or Spanish-speaking

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Ashaunta T Anderson, MD, MPH

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

November 8, 2021

First Posted

December 1, 2021

Study Start

August 6, 2018

Primary Completion

March 28, 2019

Study Completion

November 25, 2019

Last Updated

December 1, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations