Addressing Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine Tool
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05047224|
Recruitment Status : Recruiting
First Posted : September 17, 2021
Last Update Posted : June 8, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Tele-assessment + in-person assessment Behavioral: Tele-assessment only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
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.
|Official Title:||Addressing Disparities in ASD Diagnosis Using a Direct-to-home Telemedicine Tool: Evaluation of Diagnostic Accuracy, Psychometric Properties, and Family Engagement|
|Actual Study Start Date :||December 3, 2021|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||June 30, 2026|
Experimental: 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.
Behavioral: Tele-assessment + in-person assessment
Participants will complete a tele-assessment using the TAP. They will complete a traditional, in-person autism spectrum disorder assessment approximately two weeks later.
Active Comparator: Tele-assessment only
Participants in this group will receive a tele-assessment using the TAP, followed by a second, shorter tele-assessment.
Behavioral: Tele-assessment only
Participants will complete a tele-assessment using the TAP. They will complete a second, shorter tele-assessment approximately two weeks later.
- Diagnostic accuracy of the TAP [ Time Frame: 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 [ Time Frame: 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.
- Family perceptions of tele-assessment [ Time Frame: Baseline ]Family perceptions of tele-assessment will be measured by the Parent Perceptions of Telemedicine (PPT) survey. The PPT is an 11-question survey. Seven questions are measured on a three-point scale and will provide quantitative data. Each question ranges from 1 (not true) to 3 (very true). Possible survey scores can range from 7 to 21. Higher scores indicate more positive perceptions of tele-assessment.
- Family satisfaction with diagnostic services [ Time Frame: Baseline and six-month follow-up ]Family satisfaction with diagnostic services will be measured by the Parent Service Satisfaction (PSS) survey. The PSS is an 7-question survey. Questions are measured on a three-point scale ranging from 1 (not true) to 3 (very true). Possible survey scores can range from 7 to 21. Higher scores indicate higher satisfaction with diagnostic services.
- Family empowerment [ Time Frame: Baseline and six-month follow-up ]Family empowerment will be measured using the Family Empowerment Scale (FES), which asks questions about caregiver self-efficacy related to understanding, navigating, and supporting their child's needs. The FES is an 24-question survey. Questions are measured on a five-point scale ranging from 1 (never) to 5 (very often). Possible survey scores can range from 24 to 120. Higher scores indicate greater self-perceived empowerment.
- Child service access and utilization [ Time Frame: Baseline to six-month follow-up ]Child service access and use will be measured using the Service Access and Utilization (SAU) questionnaire. The questionnaires asks about receipt of Part C early intervention services as well as private therapy services. Caregivers will complete the questionnaire at seven time points (approximately 15, 30, 45, 60, 90, 120, and 180 days following initial evaluation). At each time point, caregivers will endorse service milestones they have reached (e.g., scheduled an evaluation with the Part C service system, created an Individualized Family Service Plan, began services). We will calculate time to each milestone for each participant.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Months to 42 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria 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.
Exclusion Criteria 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05047224
|Contact: Laura Corona, Ph.D.||615-936-5777||Laura.L.Corona@vumc.org|
|United States, California|
|UC Davis MIND Institute||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Devon Gangi, Ph.D. 916-703-0425|
|Principal Investigator: Sally Ozonoff, Ph.D.|
|Principal Investigator:||Zachary Warren, Ph.D.||Vanderbilt University Medical Center|
|Responsible Party:||Zachary Warren, Professor of Pediatrics, Vanderbilt University Medical Center|
|Other Study ID Numbers:||
1R01MH127228-01 ( U.S. NIH Grant/Contract )
|First Posted:||September 17, 2021 Key Record Dates|
|Last Update Posted:||June 8, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
autism spectrum disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive