The goal of this pilot randomized controlled trial is to evaluate a self-concept intervention (Self-Concept Reinforcement for Early School Readiness (SCR4ESR)) in young African American children using experimental and mixed methods. SCR4ESR provides self-concept themed children's books and advice at health supervision visits of children enrolled at ages 2-4 years.

The specific aims of the proposed project are to:

1. assess the feasibility and acceptability of SCR4ESR implementation among parents and providers,
2. evaluate the capacity of SCR4ESR to improve self-concept reinforcement and book-sharing behaviors in parents of young African American children, and 3) evaluate the capacity of SCR4ESR 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 qualitative assessment will be complemented by quantitative trial statistics (e.g., recruitment rate) that inform trial feasibility and acceptability. Finally, the mechanism by which SCR4ESR impacts the primary outcome, behavioral health, and the secondary outcome, literacy, will be evaluated by structural equation modeling. This project will inform the development and implementation of early childhood interventions that improve the health of African Americans.

Study Design. The proposed mixed methods study has 2 phases. Phase 1 will evaluate the feasibility and acceptability of SCR4ESR implementation from the perspectives of parents and providers (Aim 1, qualitative). Phase 2 will conduct a pilot randomized controlled trial (RCT) of SCR4ESR+ROR versus ROR alone in parents of 2- to 4-year-old African American children to assess SCR4ESR'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 SCR4ESR (Aim 1).

Phase 1 will recruit 15 parents and 15 providers from 2 AltaMed clinics. Eligible parents will: 1) be 18 years old or older, 2) speak English, 3) be the legal guardian of a 2- to 4-year-old African American child, and 4) have experience with ROR. The exclusion criteria include parents whose target child has severe cognitive impairment or communication difficulties (i.e., severe intellectual disability or non-verbal). We will contact over 45 families over the 3-month recruitment period. The Principal Investigator (PI) will contact eligible parents 2 weeks prior to well child visits for recruitment purposes. Parents 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. 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. The PI will begin each 1-on-1 interview with a short instructional video on ROR. The PI will then give an overview of SCR4ESR, the self-concept book list, and parent 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 SCR4ESR (Aims 2 and 3)

Aim 2: Test the capacity of SCR4ESR to improve proximal outcomes-self-concept reinforcement (SCR) and book-sharing behaviors-among parents of young African American children. Introduction. The objective of this aim is to examine the capacity of SCR4ESR to promote SCR and book-sharing behaviors in parents of 2- to 4-year-old African American children. We will test the working hypothesis that: 1) parents who receive SCR4ESR will exhibit more SCR and book-sharing behaviors than those who do not. Our approach to testing the working hypothesis will be to conduct a pilot RCT to determine the extent to which proximal intervention targets (SCR and book-sharing behaviors) are improved over a 15-month period of follow up within and between 2 groups (SCR4ESR+ROR and ROR alone). We will also quantitatively assess SCR4ESR feasibility and acceptability.

Aim 3: Test the capacity of SCR4ESR to improve exploratory distal outcomes-internalizing behaviors, externalizing behaviors, and literacy-in young African American children. Introduction. The objective of this aim is to examine the capacity of SCR4ESR to promote behavioral health and literacy in 2- to 4-year-old African American children. We will test the working hypotheses that: 1) children who receive SCR4ESR will exhibit better behavioral health and literacy than those who do not, and 2) the association between SCR4ESR and behavioral health and literacy will be mediated by parental SCR and book-sharing behaviors. Our approach to testing the working hypotheses will be to conduct a pilot RCT to determine the extent to which proximal intervention targets (SCR 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 (SCR4ESR+ROR and ROR).

Recruitment, Sampling Design, and Data Collection. Phase 2 will recruit caregivers of 134 children from 2 AltaMed clinics using the same methods we successfully employed during the preliminary study. Eligible parents will: 1) be 18 years old or older, 2) speak English, and 3) be legal guardian of the index 2- to 4-year-old African American child. The exclusion criteria include parents who: 1) have index children with severe cognitive impairment or communication difficulties (i.e., severe intellectual disability or nonverbal), 2) plan to move outside of the CHLA service area in the next 15 months, 3) are CHLA employees, or 4) participated in Aim 1 interviews. We expect to outreach to over 300 families during the 12-month recruitment period using a brief screening instrument. Potential parent-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 an RA (blinded to group assignment) will administer the baseline parent 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 sex to: 1) SCR4ESR+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 (SCR4ESR+ROR). Families assigned to the intervention will then receive SCR4ESR over 20 minutes (10 minutes content review, 10 minutes modeling book sharing, 1 children's book, and a parent handout) from the second RA (Table 5). SCR4ESR families will have a total of 5 intervention visits at 0, 3, 6, 9, and 12 months after enrollment focused on topics that support self-concept and shared book reading (Table 5) with repeat parent survey and child literacy assessment at 9 and 15 months after enrollment. The 15month 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: Families randomized to ROR alone (and those in SCR4ESR+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. Control families will complete the same parent surveys and child literacy assessments as intervention families at 0, 9, and 15 months after enrollment. Providers will not receive additional training in SCR4ESR 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 SCR4ESR effects on proximal outcomes/mediators (SCR 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, and parent ethnic identity). Preliminary exploratory data analyses will evaluate the distribution of each proximal outcome/mediator and distal outcome. If variables are not normally distributed, normalizing transformations will be attempted; rank-based non-parametric tests will be used if normalizing transformations are not successful. Evaluations of SCR4ESR intervention effects on proximal (Aim 2 SCR and book sharing) and distal (Aim 3 behavioral health and literacy) outcomes will involve group comparisons on follow-up assessments conducted by intent-to-treat (Table 6); participants will be evaluated within their randomized group, regardless of level of adherence. 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 SCR4ESR 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 sex, parenting stress, and parent ethnic identity) separately. In the entire sample, interaction terms of group by moderator will test for differences in intervention effects among these subgroups. Although we will not have statistical power to test for moderator-intervention interactions, we will nonetheless conduct stratified analyses to identify moderator-specific SCR4ESR effects.

Statistical Power. Given pilot 25% attrition rate, we will recruit 134 participants to yield 100 to study end. For 100 participants, proportions will be estimated with a 95% CI width of 0.13-0.20 (again depending on the actual proportion estimate). For the sample size of 100 (50 per group), we computed the precision of the 95% CI for estimating 1-group means (e.g., for within-group mean change) and 2-group mean differences (for intervention effect sizes) on trial outcomes. We will be able to estimate 1-group mean changes with a 95% CI that is ±0.28SD (standard deviation), and 2-group mean differences with a 95% CI that is ±0.40SD. 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 withingroup 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. We expect the mixed methods study of SCR4ESR feasibility and acceptability will allow us to improve the intervention and trial. We will gain exploratory insight into the mechanism relating SCR4ESR to behavioral health and literacy in young African American children and present findings to the CAB in Year 4.

Potential Problems and Alternative Strategies.Recruitment is a potential problem that will be addressed with a 12-month recruitment period, proactive searches for potential participants, and incentives (i.e., $20 Amazon gift cards at first 3 visits, $40 gift cards at next 3 visits, and $20 transportation stipend for each visit). Sample size may also be limited by dropout.

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

I am working on delineating the plan that would facilitate IPD sharing. Adequate resources need to be allocated to make it possible.