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School ReadinessNCT05140460

Cultural Pride Reinforcement for Early School Readiness

A study testing Cultural Pride Reinforcement for Early School Readiness (CPR4ESR) and Reach Out and Read (ROR) in people with School Readiness and Racial Socialization, run by Children's Hospital Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Cultural Pride Reinforcement for Early School Readiness (CPR4ESR) and Reach Out and Read (ROR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteUnited States
Study dates
6 Aug 2018to 25 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

Other trials in United States

About this study

Official title: Cultural Pride Reinforcement for Early School Readiness: A Quasi-Experimental Trial

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.

Read the detailed description

In order to evaluate parental delivery of cultural pride messages, child development, and health services outcomes, 106 parents of children ages 6 months to 5 years old were recruited from two child-serving health institutions in Southern California. This study utilized both an intervention group (n=67) and a control group (n=39). Recruitment and baseline intervention for this study took place on the same day, with one 3-month follow-up conducted over the telephone, and a 1-year post-enrollment review of the child's medical chart. Only a subset (n=14) participated in the medical chart review. Details of the study methodology are provided below.

Recruitment Parents were recruited from two child-serving community health clinics in Southern California. Participants were at least 18 years of age, had a child who was between 6 months and 5 years of age, was of African American, Asian, Latino race/ethnicity or diverse cultural perspective, and reported a primary language that was English or Spanish. Potential participants were identified by the health clinics' coordinating research staff and the clinical pediatrics team. Research assistants (RAs) from the study conferred with the medical staff for each pediatric team to review participant eligibility. The pediatric team distributed the study flyer to those parents who met study eligibility at their scheduled well-child or sick-child visit. Additionally, study flyers were posted at the clinic. Recruitment script and informed consent took approximately 10 minutes.

Intervention Treatment Assignment Participants comprising the intervention group and the control group were determined by designating all participating parents with office visits on even days of the month to the intervention group and all participating parents with office visits on odd days of the month to the control group.

Intervention Group The intervention entails distribution of a children's book with a cultural pride theme, the cultural pride parent book-sharing guide, and the study survey. Consented intervention participants selected and received a developmentally appropriate (baby, toddler, or preschool) book from the RA that featured African American, Latino, Asian, or diverse cultural pride perspectives. All books selected for distribution in the intervention group were vetted through a community advisory board. The cultural pride books differ from the standard ROR books distributed at office visits in that the ROR books address age-related developmental and interactive content, but do not focus on or require specific images and narratives reflective of racial, ethnic, or cultural perspectives in their content. Participating parents were asked to complete the study survey. The survey collected information on demographics, racial socialization (including cultural pride reinforcement), child development, and family-provider communication. Portions of the survey used a 5-point Likert scale to rate the extent to which parents agreed or disagreed with each item. The survey was administered via paper and pencil during the initial intervention in the clinic-designated research room. The RA remained in the room with the participants to address any questions participants may have had when completing the survey. The survey was translated into Spanish. The intervention took approximately 30 minutes: 10 minutes for recruitment/study information and consent, and 20 minutes for book material distribution and review, and survey. Confidentiality of data collected for the survey was maintained through the use of codes.

Control Group The control condition involves distribution of standard ROR book and book-sharing advice, and the study survey. Consented participants received the standard ROR reading advice and a ROR book. Some books from the standard ROR book list may include images reflective of study participants, but without a direct cultural pride message; therefore, books selected from the ROR children's book list for this study were reviewed and selected by the study PI in order to exclude any ROR books for distribution that may resemble cultural pride books. The comparison group was asked to complete the same study survey as the intervention group using the protocol described above.

Three Month Follow-Up Survey Three months following the initial intervention date at clinics with the intervention and control group participants, RAs conducted follow-up telephone calls to participants. Participants were asked, via phone, to complete the same survey as before with 1 additional question to assess feedback on the study experience. For the follow-up survey, participants were read the questions over the phone (in English or Spanish) and their responses documented on a paper survey by RAs. Confidentiality of data collected for the survey was maintained through the use of codes. The follow-up survey took approximately 10 minutes to complete.

One-Year Chart Review In the year following enrollment, clinic personnel reviewed the medical charts of the children whose parents participated in the study and agreed to the optional chart review. Chart reviews identified subsequent records for: number and type of well-child and sick-child visits, dates of office visits, vaccines status at the 1-year mark, and if documented, follow-up visits and diagnosis from emergency room care. During the initial recruitment and intervention at the office visit those participating consented parents were asked if they gave their permission for the clinic to access their child's medical charts for use in the study. Parents were provided with HIPAA information sheets and an authorization form for release of their child's protected health information.

Being tested
Cultural Pride Reinforcement for Early School Readiness (CPR4ESR), Reach Out and Read (ROR)
Keywords
Racial Socialization, Ethnic Socialization, Early Childhood, Literacy, Child Development
Medical subject headings
Literacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cultural Pride Reinforcement for Early School Readiness (CPR4ESR)Behavioural

    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.

  • Reach Out and Read (ROR)Behavioural

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

Study groups in NCT05140460
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Behavioral: Cultural Pride Reinforcement for Early School Readiness (CPR4ESR)
ControlActive comparatorNot described
Receives: Behavioral: Reach Out and Read (ROR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-Month Change in Language Development

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

    Measured: Baseline at enrollment to 3 months after enrollment

  2. 3-Month Change in Social Development

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

    Measured: Baseline at enrollment to 3 months after enrollment

  3. 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

    Measured: Baseline at enrollment to 3 months after enrollment

  4. 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

    Measured: Baseline at enrollment to 3 months after enrollment

Secondary outcomes (6)
  1. 3-Month Change in Family-Provider Communication

    3-month change in perception of the quality of communication between the family and provider

    Measured: Baseline at enrollment to 3 months after enrollment

  2. 3-Month Change in Family-Provider Cultural Understanding

    3-month change in perception of the level of cultural understanding between the family and provider

    Measured: Baseline at enrollment to 3 months after enrollment

  3. 3-Month Change in Family-Provider Cultural Concordance

    3-month change in perception of the importance of cultural concordance between the family and provider

    Measured: Baseline at enrollment to 3 months after enrollment

  4. Up-to-date Status of Well Child Visits

    Up-to-date status of well child visits at 12 months

    Measured: 12 months after study enrollment

  5. Up-to-date Status of Vaccination

    Up-to-date status of vaccination at 12 months

    Measured: 12 months after study enrollment

  6. Emergency Department Visits for Ambulatory-Sensitive Conditions

    Number of emergency department visits for ambulatory-sensitive conditions from study enrollment to 12 months after enrollment

    Measured: 12-month time period from study enrollment to 12 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start6 Aug 2018
  3. Primary completion28 Mar 2019
  4. Study completion25 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05140460
Sponsor's protocol ID
HS-17-139
Status last verified
Nov 2021
First submitted
8 Nov 2021
Last updated
1 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cultural Pride Reinforcement for Early School Readiness (CPR4ESR) and Reach Out and Read (ROR) in people with School Readiness and Racial Socialization, run by Children's Hospital Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-Month Change in Language Development (time frame: Baseline at enrollment to 3 months after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.

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