跳至主要内容
临床试验/NCT07458633
NCT07458633尚未招募不适用

Impact and Effectiveness of Training Primary Care Clinicians to Diagnose Autism in Children 18-36 Months by Primary Care Clinicians: A Multisite Study

Boston Children's Hospital0 个研究点目标入组 300 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
主要终点
ASD Screen to Diagnostic Resolution

研究概览

简要总结

This study is looking at time to diagnostic resolution for children ages 18-36 months with concern of ASD. The main purpose of this research study is to see if the time between when a child aged 18-36 months fails an autism screen or a clinician raises concern and is evaluated is shorter in the primary care practices where the clinicians have been trained to conduct diagnostic evaluations. The training includes use of the Childhood Autism Rating Scale-2, which is validated for use in children 2 and older. The investigators also want to learn more about whether primary care clinicians can accurately evaluate and diagnose young children ages 18-36 months of age with autism spectrum disorder (ASD).

详细描述

The investigators will conduct a multisite hybrid 1 effectiveness-implementation cluster randomized clinical trial to determine if training Primary Care Clinicians (PCCs) to diagnose autism spectrum disorder (ASD) in young children is an effective strategy for decreasing time from a result indicative of increased likelihood of autism, as determined from a visit in primary care, to diagnostic resolution defined as either making or excluding a diagnosis of autism. The investigators will also assess diagnostic concordance between PCCs and autism experts and facilitators and barriers to implementation of this model. Through pediatric clinics, the investigators will be training primary care clinicians (PCCs) to diagnose ASD as part of an established training program, and will assess their diagnostic accuracy by prospectively enrolling patients at the time of their referral for a confirmatory evaluation by a DBP and comparing their CARS scores and certainty ratings. PCCs will be surveyed about their experiences and feedback about training.

There are 3 cohorts of participants in this study:

Group 1 are primary care clinicians, and will be consented into the study and asked to perform the following activities: complete ASD diagnostic training, either in the immediate intervention or delayed intervention group; continue conducting ASD screening per standard of care; refer patients requiring diagnostic confirmation to one of the study sites, including evaluation on diagnostic accuracy.

Group 2 are staff at a primary care practice where one or more clinician are taking part in the training. They will be given the option to participate in surveys and/or focus groups asking about the impact of this autism assessment training on their practices and workflows.

Group 3 are the parents/legally authorized representatives of patients (age 18-36 months) with a flagged result on an autism screener, distributed per standard of care by their pediatrician/PCC's office. They will be contacted by study staff and verbally consented into the study. They will be asked to complete monthly telephone surveys, for up to 8 months. A subset (referred to as Group 3B) will be referred by their PCCs for confirmatory evaluation at one of the clinical study sites. They will be asked to provide written consent for sharing of their evaluation and relevant information from their medical record.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

盲法说明

The Developmental Behavior Pediatrician (DBP). To address a secondary aim, a child who is evaluated by a primary care clinician may be seen for a confirmatory ASD evaluation. The DBP will be masked to what the Primary Care Clinician concluded at their ASD evaluation. Once the DBP completes their ASD confirmatory evaluation and concludes their own diagnosis, they will then unmask to the PCC diagnosis.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • is at the practice level:
  • Are physicians or nurse practitioners.
  • -- Currently screen children for ASD at 18 and 24 months using a standard measure
  • Willing to have practice randomized and willing to defer PCC training if they are randomized to the control group.
  • Will obtain permission from parents of children 18-36 months with a positive autism screen or clinician concern for research staff to contact them
  • Will attend all training courses, complete all requirements of training, and complete questionnaires that are designed to assess the educational intervention.
  • Will keep a record of all diagnostic evaluations they complete over the study period including those children not referred for diagnostic concordance evaluation if they are randomized to the intervention group

排除标准

  • - Are not screening children for ASD and standard intervals of 18 and 24 months using a standard meaure.

研究组 & 干预措施

Immediate training in Autism Diagnostic Evaluations

Experimental

Practices in this group will include Primary Care Clinicians who receive immediate training in a 6-session educational program designed to teach them to diagnose autism in children 18-36 months who are at high risk for ASD.

干预措施: Educational training to conduct ASD diagnostic evaluations (Diagnostic Test)

Deferred Training; control Group

No Intervention

Practices in this group will include Primary Care Clinicians who will deferred training receive similar training to the PCCs in the intervention group after data collection is complete.

结局指标

主要结局

ASD Screen to Diagnostic Resolution

时间窗: From time of study enrollment after a positive ASD screen or clinician concern to diagnostic resolution or 8 months have elapsed.

Mean time to diagnostic resolution between intervention and control sites. Time to diagnostic resolution is defined as the time from the first positive screen for autism in the practice or clinician concern raised until an evaluation is completed in which the child is either diagnosed with autism or the evaluation concludes that the child does not have autism.

次要结局

  • Diagnostic Concordance(At time of evaluations by the Developmental Behavioral Pediatrician within 3 months after the Primary Care Clinician has completed a diagnostic evaluation)
  • Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism(After subject enrollment is completed until month 31 of the study)
  • Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism(After subject recruitment is complete until month 31 of the study)

研究者

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

Carol Weitzman

Principal Investigator

Boston Children's Hospital

相似试验