Early Diagnostic Telehealth for Autism

AJ
Overseen ByAllison J Schwartz, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new telehealth approach for diagnosing autism in young children. It will evaluate the ease and effectiveness of this method for families and clinicians. The trial seeks families with children enrolled in Georgia's Babies Can't Wait program who have been identified as moderate- or high-risk for autism. Parents and caregivers must be able to complete forms and interviews in English.

As an unphased trial, this study provides families the opportunity to contribute to innovative research that could enhance autism diagnosis methods.

Do I need to stop my child's current medications for the trial?

The trial information does not specify whether your child needs to stop taking current medications. It's best to discuss this with the trial coordinators or your child's healthcare provider.

What prior data suggests that this diagnostic protocol is safe for children?

Research has shown that early diagnostic tools for autism, such as the Early Diagnostic Response Model Expanded, can help identify autism in young children. Although researchers are still studying this specific tool, similar methods have demonstrated positive results in diagnosing autism early and improving children's adaptability.

The reviewed studies did not identify any major safety issues with these diagnostic methods. Since this trial is in a "Not Applicable" phase, it focuses on the practicality and ease of use of these methods, rather than testing drug safety. The procedures are non-invasive and mainly involve assessments and questionnaires, which are generally safe.

In summary, current evidence suggests that the diagnostic methods under testing are well-tolerated and safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Early Diagnostic Response Model Expanded for autism because it leverages telehealth to provide early and accessible diagnosis. Unlike traditional in-person assessments, this approach allows children as young as 16 months to be evaluated remotely, making it more convenient for families and potentially reaching those in underserved areas. Additionally, the comprehensive use of standardized measures and parent/caregiver input throughout the process ensures a thorough and personalized assessment. This innovative model could lead to earlier interventions and better outcomes for children with suspected autism.

What evidence suggests that this diagnostic protocol is effective for early autism detection?

This trial will evaluate the Early Diagnostic Response Model Expanded, which uses telehealth to diagnose autism spectrum disorder (ASD) in young children. Studies have shown that telehealth can reliably diagnose ASD. One review found that telehealth methods accurately diagnose ASD early by using both live and recorded information. Telehealth improves access and reduces costs, making it easier for families to receive care and allowing for timely assessments. Research shows that caregivers often express high satisfaction with telehealth's mixed approaches for autism evaluations. Overall, telehealth is transforming autism diagnosis by offering effective and accessible options for families.46789

Who Is on the Research Team?

AJ

Allison J Schwartz, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for children in Georgia's Babies Can't Wait program who are considered at moderate or high risk for autism spectrum disorder. Participants must be eligible for early intervention services and referred for an autism evaluation.

Inclusion Criteria

Parent/guardian has basic English proficiency to complete intake forms and in-depth interview, and the child has exposure to English at home or in out-of-home care
Child is enrolled in a participating BCW district
Child is identified as moderate- or high-risk on the M-CHAT-R/F
See 3 more

Exclusion Criteria

My child is older than 33 months.
Non-English speaking families due to staffing and resource limitations as consent, parent interview, and child assessment are not available in other languages within this study scope
Families making self-referrals to the EAC or referred from non-onboarded BCW districts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-16 weeks

Telehealth Assessment

Children are assessed via a remote telehealth session with an EAC clinician using age-appropriate standardized measures. Feedback is provided via telehealth, and a final report with recommendations is issued.

Up to 12 weeks
Remote telehealth sessions

Follow-up

Participants are monitored for satisfaction and access to services after the assessment. Parents/caregivers and EI providers are surveyed about their experiences.

3 months
Surveys administered post-assessment and 3 months later

What Are the Treatments Tested in This Trial?

Interventions

  • Early Diagnostic Response Model Expanded

Trial Overview

The study is testing a new telehealth-based assessment protocol to diagnose autism earlier in young children. It looks at how well the process works, how satisfied families and providers are, and whether it helps speed up diagnosis compared to usual care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Families with children enrolled in BCW with suspected diagnosis of autismExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Georgia Department of Public Health

Collaborator

Trials
2
Recruited
1,400+

Citations

Use of telehealth for facilitating the diagnostic assessment of ...

We conducted a scoping review examining which telehealth approaches are used in the diagnosis and assessment of ASD in children and adults.

Telehealth Interventions for Autism Spectrum Disorder ...

This article aims to synthesize the current evidence comparing the use of telehealth and in-person interventions in terms of diagnostic ...

Early Diagnostic Response Model (EDRM)

This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.

10 Benefits of Telehealth for Autism Diagnosis and Treatment

10 Benefits of Telehealth for Autism Diagnosis and Treatment · 1. Improved Access to Care · 2. Cost-Effectiveness · 3. Enhanced Continuity of Care.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37740876/

Validation of an Enhanced Telehealth Platform for Toddlers at ...

NODA-E is a tool that can assist clinicians in making reliable and valid early ASD diagnoses using both asynchronous and synchronous information gathered via ...

Early Diagnosis of Autism Spectrum Disorder: A Review and ...

Early Start Denver Model (ESDM) interventions have shown promising results in improving IQ, adaptive behavior, and autism diagnosis in young children.

Prodromal Identification and Intervention in Autism Spectrum ...

ASD behaviors are detectable before 12 months, but preemptive interventions before 6 months remain unexplored. This case study documents ASD ...

Prevalence and Early Identification of Autism Spectrum .. ...

This report describes autism spectrum disorder prevalence and early identifications patterns among children aged 4 and 8 years old.

Multi-modal data analysis for autism spectrum disorder in ...

The ASD-Diagnostic Network hybrid learning model based on fMRI data, achieved 82 % accuracy in classifying ASD patients [47].