Translating Evidence Based Developmental Screening Into Pediatric Primary Care ( Aims 2 and 3 )
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,314
- 试验地点
- 8
- 主要终点
- The primary outcome measure for this study will be the percentage of children enrolled in the study who are identified as having a developmental delay.
研究概览
简要总结
The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the American Academy of Pediatrics (AAP's) recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age.
详细描述
The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the AAP's recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age. The study will also examine its acceptance by pediatric practices, its adoption and adaptation in urban pediatric practices, and the effectiveness of a developmental screening protocol that conforms to the AAP and Maternal and Child Health Bureau (MCHB) recommendations compared with that of developmental surveillance alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age birth to 30 months of age by the start of the intervention phase.
- •Child's Primary Care Physician has consented to participate in the study
- •Parental/guardian permission (informed consent).
排除标准
- •Premature Infants (less than 36 weeks of gestation)
- •Children with prior identified developmental delay.
- •Children with major congenital anomalies/genetic disorders
- •Children placed in foster care
研究组 & 干预措施
SRS
School Readiness Specialist (SRS) will administer the screening questionnaire to the subject during the intervention period, at the subject's 9, 18, 24 and 30 month visits. They will then see their PCP for a well child visit in which the results of the test will be interpreted, developmental counseling and/or anticipatory guidance provided as per usual care. EI (Early intervention) referral will be completed, at the discretion of the providers, if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
干预措施: Developmental screening using ASQ and MCHAT (Other)
Provider
Primary Care Physician (PCP) will do the developmental screening at the subject's 9, 18, 24 and 30 month well child visits. Once the screening questionnaire is complete the PCP will then score the screening tool and interpret the test results. Developmental counseling and/or anticipatory guidance will be provided, as per usual care. EI (Early intervention) referral will be completed, at the discretion of the providers, if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
干预措施: Developmental screening using ASQ and MCHAT (Other)
Routine
Subjects randomized to routine surveillance will receive routine preventive care as well as developmental surveillance at all well child visits, including the 9, 18, 24 and 30 month visits. EI referral will be completed, at the discretion of the provider, if the PCP observes a developmental delay during surveillance or the caregivers raise a specific concern about the child's development.
结局指标
主要结局
The primary outcome measure for this study will be the percentage of children enrolled in the study who are identified as having a developmental delay.
时间窗: We assessed this between June to October 2010
次要结局
- Percent of parents enrolled in the study who report as satisfied with the intervention(We assessed this between March and September 2010)
- Percent of providers enrolled in the study who report as satisfied with the intervention.(We will assess this between March and September 2010)
- Percentage of children in the study who enroll in Early Intervention Services(We will assess this between June to October 2010)
- Percentage of children in the study who are referred to Early Intervention Services(We assessed this in June 2010)