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.
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
- Conditions the study is for
- School Readiness, Racial Socialization, Child Development
- What is being tested?
- Cultural Pride Reinforcement for Early School Readiness (CPR4ESR) and Reach Out and Read (ROR)
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- School Readiness, Racial Socialization, Child Development
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Cultural Pride Reinforcement for Early School Readiness (CPR4ESR) |
| Control | Active comparator | Not 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.
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
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-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
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)
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
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-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
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
Up-to-date Status of Vaccination
Up-to-date status of vaccination at 12 months
Measured: 12 months after study enrollment
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.
- First posted1 Dec 2021
- Study start6 Aug 2018
- Primary completion28 Mar 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School ReadinessStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashaunta Anderson, Children's Hospital Los Angeles
- Investigators
- Ashaunta T Anderson, MD, MPH, Principal investigator, Children's Hospital Los Angeles
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Pride Reinforcement for Early School Readiness: A Quasi-Experimental Trial
- ClinicalTrials.gov ID
- NCT05140460
- Acronym / sponsor ID
- HS-17-139
- Conditions
- School Readiness, Racial Socialization, Child Development
- Keywords
- Racial Socialization, Ethnic Socialization, Early Childhood, Literacy, Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cultural Pride Reinforcement for Early School Readiness (CPR4ESR) |
| Control | Active comparator | Behavioral: Reach Out and Read (ROR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Parent of at least 1 child 6 months to 5 years old
- English-speaking or Spanish-speaking
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cultural Pride Reinforcement for Early School Readiness (CPR4ESR)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. | Behavioural | Intervention |
| Reach Out and Read (ROR)The control condition involves distribution of a standard ROR book and book-sharing advice. Distributed books are developmentally appropriate (baby, toddler, or preschool). | Behavioural | Control |
Primary outcome
3-Month Change in Language Development
Time frame: Baseline at enrollment to 3 months after enrollment
3-month change in the percentage of child participants who achieved all age-appropriate language development milestones
3-Month Change in Social Development
Time frame: Baseline at enrollment to 3 months after enrollment
3-month change in the percentage of child participants who achieved all age-appropriate social development milestones
3-Month Change in Fine Motor Development
Time frame: Baseline at enrollment to 3 months after enrollment
3-month change in the percentage of child participants who achieved all age-appropriate fine motor development milestones
3-Month Change in Gross Motor Development
Time frame: Baseline at enrollment to 3 months after enrollment
3-month change in the percentage of child participants who achieved all age-appropriate gross motor development milestones
6 secondary outcomes
3-Month Change in Family-Provider Communication
Time frame: Baseline at enrollment to 3 months after enrollment
3-Month Change in Family-Provider Cultural Understanding
Time frame: Baseline at enrollment to 3 months after enrollment
3-Month Change in Family-Provider Cultural Concordance
Time frame: Baseline at enrollment to 3 months after enrollment
Up-to-date Status of Well Child Visits
Time frame: 12 months after study enrollment
Up-to-date Status of Vaccination
Time frame: 12 months after study enrollment
Emergency Department Visits for Ambulatory-Sensitive Conditions
Time frame: 12-month time period from study enrollment to 12 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashaunta T Anderson, MD, MPH principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
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.