Facilitating Autism Diagnosis in Shorter Timeframes by PCCs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational training to conduct ASD diagnostic evaluations.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact and Effectiveness of Training Primary Care Clinicians to Diagnose Autism in Children 18-36 Months by Primary Care Clinicians: A Multisite Study
Overview
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).
Detailed description
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.
Interventions
- Diagnostic test Educational training to conduct ASD diagnostic evaluations
The intervention is being trained in a 6-session curriculum designed to teach primary care clinicians to conduct autism diagnostic evaluations.
Primary outcome measures
- ASD Screen to Diagnostic Resolution [Time frame: From time of study enrollment after a positive ASD screen or clinician concern to diagnostic resolution or 8 months have elapsed.]
Secondary outcome measures (5)
- Diagnostic Concordance [Time frame: 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 [Time frame: After subject enrollment is completed until month 31 of the study]
- Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism [Time frame: After subject enrollment is completed until month 31 of the study]
- Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism [Time frame: After subject recruitment is complete until month 31 of the study]
- Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism [Time frame: After subject enrollment is completed until month 31 of the study]
Eligibility criteria
Inclusion Criteria 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
Exclusion criteria
\- Are not screening children for ASD and standard intervals of 18 and 24 months using a standard meaure.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07458633 · IRB-P00052418