Pediatric Early Autism Recognition System: PEARS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T
研究概览
简要总结
The goal of the study is to assess a new autism evaluation model that would include the addition of a Level-2 autism screener, the Rapid Interactive Screening Test for Autism in Toddlers (RITA-T), to the developmental screening already done by the child's pediatrician.
The study hypotheses:
- The PEARS intervention will show high feasibility to primary care physicians (PCPs) and patient families.
- The PEARS intervention will lead to increased parent activation around autism diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T
时间窗: Approximately day 7 (Time 3)
This is based on a 6 question feasibility survey (score of 24 or greater would be considered feasible).
Percentage of parents that felt that the RITA-T visit was comfortable and useful
时间窗: Approximately day 35 (time 5)
This is based on a 5 question feasibility survey (score of 20 or greater would be considered feasible).
Change on the Parent Activation Measure for Children with Developmental Disabilities (PAM-DD)
时间窗: Baseline(day 1), approximately day 35 (time 5)
Items are scored using a 4-point a Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0 to 100 using weighted scores based on Guttman scaling. Higher scores correspond to higher activation. This 13-item measure will be administered verbally to parents at baseline and 3-4 weeks post-RITA-T assessment. Changes from baseline to follow-up will be calculated for each participant.
Qualitative data from parents semi-structured interviews
时间窗: Approximately day 35 (time 5)
The study team will analyze transcripts of parent semi-structured interviews to assess general sense of empowerment and motivation, with a focus on novel insights into the experience of parents of children undergoing a Level-2 screening instrument within the medical home.
次要结局
- The number of days between enrollment and completed RITA-T assessment(Approximately 7-14 days)
- The percentage of participants that experienced scheduling and/or transportation barriers(Approximately day 35 (time 5))
研究者
Nicole Hamp
House Officer, Developmental-Behavioral Pediatrics
University of Michigan
