Addressing Disparities in ASD Diagnosis Using a Direct-to-home Telemedicine Tool: Evaluation of Diagnostic Accuracy, Psychometric Properties, and Family Engagement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 664
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the TAP
研究概览
简要总结
The investigators propose to evaluate the use of a telemedicine tool, the TELE-ASD-PEDS (TAP), that is designed to assess for autism spectrum disorder (ASD) symptoms in toddlers. The TAP was developed at VUMC by a team of clinical psychologists with expertise in the early identification of ASD. The TAP has been studied in controlled laboratory settings, with high levels of family and clinician satisfaction, as well as excellent agreement with blinded comprehensive ASD evaluation. The TAP has also been used to complete direct-to-home telemedicine assessments during the COVID-19 pandemic. However, the investigators have not yet compared direct-to-home assessments using the TAP with gold standard, in-person ASD assessments. It has also not yet been studied in a diverse sample of families or with providers outside of VUMC. This study will allow the investigators to address those gaps.
详细描述
The investigators propose to evaluate the use of a telemedicine tool, the TELE-ASD-PEDS (TAP), that is designed to assess for autism spectrum disorder (ASD) symptoms in toddlers. This study will recruit 360 toddlers (18-42 months of age) across two sites (VUMC and the University of California, Davis). All toddlers will receive in-home telemedicine assessment for ASD using the TAP. This study has two aims. The first aim will randomize participants to receive either (1) telemedicine assessment and an in-person ASD assessment or (2) telemedicine-based assessment only. The investigators will measure diagnostic accuracy of the TAP in comparison to gold standard, in-person ASD assessment. The investigators will also assess test-retest reliability, inter-rater reliability, and the sensitivity, specificity, and positive predictive value of the TAP. In the second aim, all 360 families will be followed over six months to evaluate service access, family engagement, and family perceptions of the diagnostic process.
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
- Single (Care Provider)
盲法说明
Clinicians conducting in-person diagnostic evaluations will be blind to the outcomes of initial telehealth diagnostic appointments until after in-person assessments are administered and scored. Clinicians will be unblinded to telehealth diagnostic outcomes prior to sharing the results of in-person assessment with families.
Clinicians conducting the second telehealth appointments for test-retest and interrater reliability purposes will be blind to recruitment pathway and diagnostic outcome from the initial telehealth appointment.
入排标准
- 年龄范围
- 18 Months 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Children:
- •Child between 18 and 42 months of age
- •Child and primary caregiver live within a 3-hour driving radius of one of the sites (i.e., VUMC or UC Davis)
- •Inclusion Criteria for Caregivers:
- •Age 18 years or older
- •Parent or legal guardian of participating child
- •Has access to technology (e.g., phone, laptop, or tablet with internet connection and audio-visual capabilities) to connect to the tele-assessment platform
- •Sufficient facility with English to participate in the procedures and complete study measures.
排除标准
- •for Children:
- •Severe sensorimotor impairment that cannot be corrected and would interfere with completion of study activities
- •Medical conditions for which tele-evaluation of ASD symptoms is likely to be inappropriate or complex (i.e., rare genetic syndromes, severe epilepsy, fragile health).
研究组 & 干预措施
Tele-assessment + in-person assessment
Participants in this group will receive a tele-assessment using the TAP and will attend a traditional, in-person evaluation for autism spectrum disorder in a clinic setting.
干预措施: Tele-assessment + in-person assessment (Behavioral)
Tele-assessment only
Participants in this group will receive a tele-assessment using the TAP, followed by a second, shorter tele-assessment.
干预措施: Tele-assessment only (Behavioral)
结局指标
主要结局
Diagnostic accuracy of the TAP
时间窗: Baseline to completion of in-person autism evaluation, approximately two weeks
The investigators will compare diagnoses made from the tele-assessment using TAP to those from in-person evaluation. We will calculate the percent agreement between diagnoses assigned in each condition.
Validity of the TAP
时间窗: Baseline to completion of in-person autism evaluation, approximately two weeks
Validity of the TAP will be measured by assessing the psychometric properties of the tool. Estimated performance metrics will include positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity of the TAP.
次要结局
- Family empowerment(Baseline and six-month follow-up)
- Family satisfaction with diagnostic services(Baseline and six-month follow-up)
- Child service access and utilization(Baseline to six-month follow-up)
- Family perceptions of tele-assessment(Baseline)
研究者
Zachary Warren
Professor of Pediatrics
Vanderbilt University Medical Center