Self-Concept Reinforcement for Early School Readiness: Pilot Randomized Controlled Trial of a Clinic-Based Intervention for Young African American Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Mean change from baseline for externalizing behavior score for Child Behavioral Health as measured by Child Behavior Checklist
研究概览
简要总结
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:
- assess the feasibility and acceptability of SCR4ESR implementation among parents and providers,
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean change from baseline for externalizing behavior score for Child Behavioral Health as measured by Child Behavior Checklist
时间窗: Baseline to 15 months post-enrollment
Child Behavior Checklist - Externalizing behaviors. Items rated on a Likert scale from 0 to 2. The items are divided across categories and summed by category such that higher sums amount to more behavioral problems. 2-3 years old: minimum/maximum scores 0 to 128. 4 years and older: minimum/maximum scores 0 to 236.
Mean change from baseline for internalizing behavior score for Child Behavioral Health as measured by Child Behavior Checklist
时间窗: Baseline to 15 months post-enrollment
Child Behavior Checklist - internalizing behaviors. Items rated on a Likert scale from 0 to 2. The items are divided across categories and summed by category such that higher sums amount to more behavioral problems. 2-3 years old: minimum/maximum scores 0 to 128. 4 years and older: minimum/maximum scores 0 to 236.
次要结局
- Mean change from baseline Self-Concept Reinforcement using Hughes' Socialization Scale.(Baseline to 15 months post-enrollment)
- Mean change from baseline for Child Early Language Skills using the Receptive One-Word Picture Vocabulary Test.(Baseline to 15 months post-enrollment)
- Mean change from baseline for Child Early Literacy Skills using the The Reading House for participants 3-5 years old.(Baseline to 15 months post-enrollment)
- Mean change from baseline for Bookreading Quantity Subdimension using STIMQ 2-READ Scale(Baseline to 15 months post-enrollment)
- Mean change from baseline for Diversity of Content/Concepts using STIMQ 2-READ Scale.(Baseline to 15 months post-enrollment)
- Mean change from baseline Bookreading Quality Subdimension using STIMQ 2-READ Scale.(Baseline to 15 months post-enrollment)
研究者
Ashaunta Anderson
Assistant Professor of Pediatrics
Children's Hospital Los Angeles