RECRUITING

Early Diagnostic Response Model (EDRM)

Conditions

Autism Spectrum Disorder Autism Early Intervention Telehealth Assessment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.

Official Title

Early Diagnostic Response Model (EDRM): Evaluating an Early Screening to Evaluation Pilot Protocol for Children Identified as High Risk for Autism in 3 Pilot Early Intervention Health Districts

Quick Facts

Study Start:2022-06-16

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05419895

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Months to 36 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* All families of children between the ages of 16-30 months of age who scored ≥8 on the MCHAT-R and whose BCW provider refers the child to our clinic by 33 months of age will be a possible participant. Evaluations will be done by 36 months of age. * Referring BCW provider must be one of the three targeted BCW districts participating in this pilot study. * Parent/Guardian needs to have basic English proficiency * Parent/Guardian needs to have internet access * Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting). * Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.	* Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study. * Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age. * Non-English speakers will be excluded from participation due to the current protocol not being applicable to their needs as well as a high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.

Inclusion Criteria

Exclusion Criteria

* All families of children between the ages of 16-30 months of age who scored ≥8 on the MCHAT-R and whose BCW provider refers the child to our clinic by 33 months of age will be a possible participant. Evaluations will be done by 36 months of age.
* Referring BCW provider must be one of the three targeted BCW districts participating in this pilot study.
* Parent/Guardian needs to have basic English proficiency
* Parent/Guardian needs to have internet access
* Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting).
* Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.

* Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.
* Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age.
* Non-English speakers will be excluded from participation due to the current protocol not being applicable to their needs as well as a high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.

Contacts and Locations

Study Contact

Allison Schwartz, PhD

CONTACT

404.727.8350

allison.schwartz@emory.edu

Principal Investigator

Allison Schwartz, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory Autism Center

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Allison Schwartz, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-16

Study Completion Date2025-06

Study Record Updates

Study Start Date2022-06-16

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

Autism
Early Intervention
Telehealth
Assessment

Additional Relevant MeSH Terms

Autism Spectrum Disorder
Autism