Educational training to conduct ASD diagnostic evaluations
Diagnostic TestThe intervention is being trained in a 6-session curriculum designed to teach primary care clinicians to conduct autism diagnostic evaluations.
NCT Number: NCT07458633
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
is at the practice level:
-- Currently screen children for ASD at 18 and 24 months using a standard measure
Exclusion criteria
The intervention is being trained in a 6-session curriculum designed to teach primary care clinicians to conduct autism diagnostic evaluations.
Time frame: 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.
Time frame: At time of evaluations by the Developmental Behavioral Pediatrician within 3 months after the Primary Care Clinician has completed a diagnostic evaluation
Agreement between Primary Care Clinician evaluation versus Developmental Behavioral Pediatrician evaluation (diagnostic concordance) on the CARS-2 (Childhood Autism Rating Scale- 2nd Edition, Standard Version), a 15 item well recognized measure used to help identify and assess the severity of autism spectrum disorder (ASD) in children. Clinician Confidence in Diagnostic Assessment will be rated on a 5-point Likert scale from 1= Not at all sure of diagnostic conclusion to 5=Highly certain of diagnostic conclusion.
Time frame: After subject enrollment is completed until month 31 of the study
Descriptive statistical (means, SD or median, IQR for non-parametric data) summaries of responses to the Acceptability of Intervention Measure ( 4 item measure with scale of 1-5 with higher scores indicating endorsement of acceptability)
Time frame: After subject enrollment is completed until month 31 of the study
Descriptive statistical (means, SD or median, IQR for non-parametric data) summaries of responses to the Intervention Appropriateness Measure ( 4 item measure with scale of 1-5 with higher scores indicating endorsement of intervention appropriateness)
Time frame: After subject recruitment is complete until month 31 of the study
Descriptive statistical (means, SD or median, IQR for non-parametric data) summaries of responses to the Feasibility of Intervention Measure (4 item measure with scale of 1-5, with higher scores indicating endorsement of feasibility)
Time frame: After subject enrollment is completed until month 31 of the study
Qualitative analysis of interviews of selected key informants including of PCCs, nurses, practice administrators and parents of children who were evaluated by PCCs in the primary care practice.
Contact information is provided by the study sponsor or research team.
Boston Children's Hospital
Other
Impact and Effectiveness of Training Primary Care Clinicians to Diagnose Autism in Children 18-36 Months by Primary Care Clinicians: A Multisite Study
Acronym: FAST-ASD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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