Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05140460 |
Other study ID # |
HS-17-139 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 6, 2018 |
Est. completion date |
November 25, 2019 |
Study information
Verified date |
November 2021 |
Source |
Children's Hospital Los Angeles |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.