Developing and Testing a New Model for Telephone-based Early Childhood Developmental Screening and Care Coordination in Vulnerable Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Number of Participants Screened With a Validated Tool
研究概览
简要总结
The purpose of this research study is to test the effectiveness of telephone-based early childhood developmental screening and care coordination, compared to usual care in a primary care pediatrics clinic. Investigators randomized 152 participants to one of two study arms, with the intervention families receiving developmental screening over the phone, and control families receiving usual care with their pediatricians.
详细描述
Although the American Academy of Pediatrics (AAP) recommends universal early childhood developmental screening as part of routine well-child care, there have been many studies documenting that many pediatricians do not follow the AAP guidelines. One intervention that has the potential to improve care, especially for low-income families, is centralized, telephone-based developmental screening, and care coordination for families whose children have developmental or behavioral concerns. 2-1-1 Los Angeles developed such an intervention and this study aims to test its effectiveness, in partnership with a local community clinic, using a randomized, controlled study design. Investigators partnered with the Clinica Oscar A Romero, a federally-qualified health center in Los Angeles, serving predominantly low-income Latino families. Investigators hope to enroll up to 300 families in the study. Eligible families will have children ages 12 to 42 months of age who receive well-child care at the clinic. As investigators obtain informed consent and enroll families, they will randomize study participants into intervention and control groups. Intervention group families will be transferred to 211 Los Angeles to complete developmental screening over the phone, while control group families will go to their pediatricians for well-child care as usual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 42 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •child receives well-child care at the clinic
- •child is not already receiving intervention services for a developmental disability
- •parent speaks Spanish or English well enough to be interviewed
排除标准
- •child is younger than 12 months or older than 42 months at time of enrollment
- •child is already receiving intervention services for a developmental disability
- •parent is unable to speak Spanish or English well enough to be interviewed
结局指标
主要结局
Number of Participants Screened With a Validated Tool
时间窗: 6 months
We will measure whether developmental screening was done using a validated instrument, as recommended by the AAP. Specific screening instruments include the Parental Evaluation of Developmental Status (PEDS), the PEDS: Developmental Milestones (PEDS:DM), the Ages and Stages Questionnaires (ASQ), and/or the Modified Checklist for Autism in Toddlers (MCHAT), Revised version.
Number of Participants That Receive Services
时间窗: 6 months
Based on medical record review, parent report, and 211 data, we will measure whether children are receiving intervention services, including Early Intervention or Special Education.
次要结局
- Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always(Baseline and 6 months)
- Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)(6 months)
研究者
Paul Chung
Associate Professor of Pediatrics
University of California, Los Angeles
