Clinical trial NCT06084910: Cultural Pride Reinforcement for Early School Readiness Study
Official title: Cultural Pride Reinforcement for Early School Readiness: Pilot Randomized Controlled Trial of a Clinic-Based Intervention for Young African American Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Behavior
Child Behavior Problem
Child Behavior Disorders
Racism
Keywords: Child Behavior
Literacy
Early Childhood
Parenting
Racism
Cultural Pride
Racial Socialization
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-10-16
Enrollment: 134
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: African American children disproportionately experience racism, which is associated with behavioral health problems and school failure. Behavioral health problems impede learning and are more likely to be chronic, severe, disabling, and untreated in African Americans compared to Whites. Clinic-based interventions that boost cultural pride may improve outcomes related to behavioral health in young African American children. However, little is known about cultural pride interventions in this population. It is important to understand these processes in young children because early childhood is a period during which racial bias may develop and stymie behavioral health and learning, and cultural pride may support it. This project will recruit patients from primary care clinics in Los Angeles. The project will test a cultural pride intervention (Cultural Pride Reinforcement for Early School Readiness (CPR4ESR)) in young African American children. CPR4ESR provides culturally themed children's books and advice at health supervision visits of children enrolled at ages 2-4 years. It is based on a well-established national program called Reach Out and Read (ROR). ROR provides children's books and book-sharing advice at health supervision visits with reports of increased book-sharing behaviors and literacy. The specific aims of the proposed project are to: 1) assess the feasibility and acceptability of CPR4ESR implementation among parents and providers, 2) evaluate the capacity of CPR4ESR to improve cultural pride reinforcement and book-sharing behaviors in caregivers of young African American children, and 3) evaluate the capacity of CPR4ESR 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 mechanism by which CPR4ESR impacts behavioral health and literacy will be evaluated by statistical modeling. We hypothesize that: 1) caregivers who receive CPR4ESR will exhibit more CPR and book-sharing behaviors than those who do not, 2) children who receive CPR4ESR will exhibit better behavioral health and literacy than those who do not, and 3) increases in caregiver CPR and book-sharing behaviors will be associated with enhanced child behavior and literacy. This project will inform the development of interventions that address the negative health impact of racism on young African American children.

Detailed description: Study Design. This mixed methods study has 2 phases. Phase 1 will evaluate the feasibility and acceptability of Cultural Pride Reinforcement for Early School Readiness (CPR4ESR) implementation from the perspectives of caregivers and providers (Aim 1, qualitative). Phase 2 will conduct a pilot randomized controlled trial (RCT) of CPR4ESR+Reach Out and Read (ROR) versus ROR alone in caregivers of 2- to 4-year-old African American children to assess CPR4ESR's impact on parenting behaviors, child behavioral health, and literacy; and to assess feasibility of the trial (Aims 2 \& 3, quantitative).

Phase 1: Evaluation of the Feasibility and Acceptability of CPR4ESR (Aim 1).

Recruitment, Sampling Design, and Data Collection. Phase 1 will recruit 15 caregivers and 15 providers from 2 or more clinics in Los Angeles.

Study staff will contact over 45 families over the 3-month recruitment period. The Principal Investigator (PI) will contact eligible caregivers 2 weeks prior to well child visits for recruitment purposes. Caregivers who provide informed consent by telephone will be scheduled for interviews following their children's well child visits. The informed consent form will be signed prior to interviews. The PI will also review next-day and day-of patient lists to identify potential participants. Recruitment will also include in-person recruitment at the participating clinics in Los Angeles. Study flyers will be posted at the clinic.

The PI will recruit providers-including clinic leaders-through electronic mail and study flyers. Eligible providers must be board-certified pediatricians who completed an accredited residency program and have ROR experience. Sixty-minute key informant interviews will take place in a private space at the clinic or online. Study staff will make the interview process convenient and efficient. The PI will begin each 1-on-1 interview with a short instructional video on ROR. The PI will then give an overview of CPR4ESR, the cultural pride book list, and caregiver handouts before asking prepared questions from the interview guide. Interview transcripts will be analyzed using standard qualitative methods.

Phase 2: Pilot Randomized Controlled Trial of CPR4ESR (Aims 2 and 3)

Aim 2: Test the capacity of CPR4ESR to improve proximal outcomes-cultural pride reinforcement (CPR) and book-sharing behaviors-among caregivers of young African American children. This will test the working hypothesis that: 1) caregivers who receive CPR4ESR will exhibit more CPR and book-sharing behaviors than those who do not. The approach to testing the working hypothesis will be to conduct a pilot RCT to determine the extent to which proximal intervention targets (CPR and book-sharing behaviors) are improved over a 15-month period of follow up within and between 2 groups (CPR4ESR+ROR and ROR alone). The study will also quantitatively assess CPR4ESR feasibility and acceptability.

Aim 3: Test the capacity of CPR4ESR to improve exploratory distal outcomes-internalizing behaviors, externalizing behaviors, and literacy-in young African American children. The objective of this aim is to examine the capacity of CPR4ESR to promote behavioral health and literacy in 2- to 4-year-old African American children. This will test the working hypotheses that: 1) children who receive CPR4ESR will exhibit better behavioral health and literacy than those who do not, and 2) the association between CPR4ESR and behavioral health and literacy will be mediated by caregiver CPR and book-sharing behaviors. The approach to testing the working hypotheses will be to conduct a pilot RCT to determine the extent to which proximal intervention targets (CPR and book-sharing behaviors) act as mediators of improved distal targets (behavioral health and literacy) over a 15-month period of follow up within and between 2 groups (CPR4ESR+ROR and ROR).

Recruitment, Sampling Design, and Data Collection. Phase 2 will recruit caregivers of 134 children from 2 clinics in Los Angeles using the same methods successfully employed during a preliminary study. Study staff will outreach to over 300 families during the 18-month recruitment period using a brief screening instrument. Potential caregiver-child dyads will be identified by the Research Coordinator (RC) who will review the list of patients scheduled for well child visits 2 weeks prior to each clinic day. Those who are unscheduled, but due for a well child visit will also be contacted. The remaining recruitment procedures are identical to those of Phase 1, including next-day and day-of screening, and appointment reminder phone calls.

Enrollment procedures. All consenting families will attend the enrollment well child visit with standard ROR. Then a Research Assistant (RA) (blinded to group assignment) will administer the baseline caregiver survey and child literacy assessment over 60 minutes. Next, a second RA will use the randomization module of the REDCap data capture system to randomize families in a 1:1 allocation to 1 of 2 trial arms stratified by clinic, age, and gender to: 1) CPR4ESR+ROR, or 2) ROR alone. If more than 1 child in a family meet inclusion criteria, 1 child will be randomly selected for participation. The blinded RA will remain responsible for subsequent assessments.

Experimental Group (CPR4ESR+ROR). Families assigned to the intervention will then receive CPR4ESR over 20 minutes (10 minutes content review, 10 minutes modeling book sharing, 1 children's book, and a caregiver handout) from the second RA. CPR4ESR families will have a total of 5 intervention visits at 0, 3, 6, 9, and 12 months after enrollment focused on topics that support cultural pride and shared book reading with repeat caregiver survey and child literacy assessment at 9 and 15 months after enrollment. The 15-month survey will also assess intervention feasibility and acceptability items adapted from the qualitative items in Aim 1. Intervention visits are designed to overlap with well child visits where ROR is delivered. Due to the schedule of well child visits by age, children will receive different doses of ROR over the 15-month study period: 3 (24-, 30-, and 36-month visits) or 2 (30- and 36-, 36- and 48-, or 48- and 60-month visits) ROR doses.

Treatment-as-Usual Control Group: Reach Out and Read (ROR). Families randomized to ROR alone (and those in CPR4ESR+ROR) will receive standard ROR book-sharing advice and 1 ROR children's book at 2 or 3 well child visits per the schedule of ROR doses discussed above. ROR books do not require specific images or narratives reflective of race, ethnicity, or culture. Control families will complete the same caregiver surveys and child literacy assessments as intervention families at 0, 9, and 15 months after enrollment. Providers will not receive additional training in CPR4ESR or ROR to reduce the chance of contamination between study groups.

Analysis Plan. The Phase 2 analytic plan entails: 1) preliminary exploratory data analyses, 2) summaries of trial statistics, 3) analyses of CPR4ESR effects on proximal outcomes/mediators (CPR and book sharing) and distal outcomes (child behavioral health and literacy), 4) exploratory evaluations of mediation, and 5) exploratory evaluation of moderators (child sex, parenting stress, caregiver ethnic identity, and caregiver perceived racial discrimination). Preliminary exploratory data analyses will evaluate the distribution of each proximal outcome/mediator and distal outcome. Analyses will also employ bivariate scatterplots and correlations, Pearson's correlation coefficients and variance inflation, spaghetti plots of proximal and distal outcomes, group means and medians of variables, and proportions of trial statistics. Evaluations of CPR4ESR intervention effects on proximal and distal outcomes will involve group comparisons on follow-up assessments conducted by intent-to-treat. The randomized groups will be compared on the mean levels of outcomes assessed at 0-, 9- and 15-months post-randomization using mixed effects linear models. A group\*time interaction will test if the intervention effects on changes in outcomes differ at 9 and 15 months. Significance testing will use a 2-sided P value of 0.05. Mediation analyses will use cross-lagged structural equation modeling (SEM) to evaluate: (1) the effect of CPR4ESR on the potential mediating variables (CPR measured in Hughes' Racial Socialization Scale and book-sharing behaviors measured in the book-sharing scale, (2) the associations of CPR and book sharing with subsequent distal outcomes (behavioral health and literacy), (3) the cross-lagged associations of behavioral health and literacy outcomes on subsequent CPR and book sharing, and (4) estimates of the direct effects (not through mediators) and indirect (mediated) effects of CPR4ESR on distal outcomes. Bias-corrected bootstrapped estimates and 95% CIs on the indirect (mediated) effects will be made. Covariates will include randomization stratification variables, age, gender, and clinic. Analyses will test for moderated mediation by gender.

Secondary Exploratory Moderator Analyses. All analyses will be stratified by potential moderators (child gender, parenting stress, caregiver ethnic identity, and caregiver perceived racial discrimination) separately. In the entire sample, interaction terms of group by moderator will test for differences in intervention effects among these subgroups.

Statistical Power. Given pilot 25% attrition rate, study staff will recruit 134 participants to yield 100 to study end. For 100 participants, proportions will be estimated with a 95% Confidence Interval (CI) width of 0.13-0.20. Study staff will be able to estimate 1-group mean changes with a 95% CI that is ±0.28 SD (standard deviation), and 2-group mean differences with a 95% CI that is ±0.40 SD. This pilot trial is not designed to statistically detect intervention group differences on outcomes. Nonetheless, the sample size of 50 per group will allow detection of group differences with medium Cohen's d effect sizes (mean group difference/SD) of 0.57 and higher (at 80% power, 2-sided alpha=0.05) and within-group Cohen's d effect sizes of 0.40 and higher. The sample size of 100 will also allow for detection of correlations (e.g., between proximal and distal outcomes) of 0.28 and higher at 80% power.

Expected Outcomes. The quantitative and qualitative assessments of CPR4ESR feasibility and acceptability will allow us to improve the intervention and trial. In addition, the study will provide exploratory insight into the mechanism relating CPR4ESR to behavioral health and literacy in young African American children.

Potential Problems and Alternative Strategies. Recruitment is a potential problem that will be addressed with an 18-month recruitment period and proactive searches for potential participants. Sample size may also be limited by dropout. This study will institute the retention methods used in prior studies. If sample size remains low despite these efforts, study staff will use the pilot experience to develop new recruitment and retention strategies and add more sites in a fully powered trial of CPR4ESR.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Child Behavioral Health
timeFrame: 0, 9, and 15 months post-enrollment
Secondary outcomes:
measure: Child Early Language Skills
timeFrame: 0, 9, and 15 months post-enrollment
measure: Child Early Literacy Skills
timeFrame: 0 and 15 months post-enrollment
measure: Book-sharing Behaviors
timeFrame: 0, 9, and 15 months post-enrollment
measure: Cultural Pride Reinforcement
timeFrame: 0, 9, and 15 months post-enrollment
Other outcomes:
measure: Book-sharing beliefs
timeFrame: 0 and 15 months
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Ashaunta T Anderson, MD, MPH, MSHS
role: PRINCIPAL_INVESTIGATOR
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