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临床试验/NCT05153551
NCT05153551已完成不适用

Pediatric Early Autism Recognition System: PEARS

University of Michigan6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月27日最近更新:
适应症

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:

  1. The PEARS intervention will show high feasibility to primary care physicians (PCPs) and patient families.
  2. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicole Hamp

House Officer, Developmental-Behavioral Pediatrics

University of Michigan

研究点 (6)

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