Viewing Study NCT06246890



Ignite Creation Date: 2024-05-06 @ 8:05 PM
Last Modification Date: 2024-10-26 @ 3:20 PM
Study NCT ID: NCT06246890
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-02-07
First Post: 2024-01-30

Brief Title: Autism ALERT Expansion
Sponsor: Oregon Health and Science University
Organization: Oregon Health and Science University

Study Overview

Official Title: Autism Access Link for Early Referral and Treatment Expansion
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Autism Access Link for Early Referral and Treatment ALERT the intervention proposed in this application is a novel state-wide referral and case management platform that PCPs can activate to ensure that a child with suspected ASD receives all necessary ASD diagnosis and treatment resources in a single referral radically simplifying a complex diagnostic and treatment process We hypothesize that Autism ALERT will have strong acceptability and high rates of use among primary care providers as well as among diverse low-income parents of children at risk for ASD and that we will see increased rate of child ASD educational evaluations within six months and shortened time between referral and ASD treatment
Detailed Description: Though significant research effort has focused on autism spectrum disorder ASD screening less attention has been devoted to optimizing follow-up of children who are subsequently identified as at-risk Despite increases in ASD screening rates many children with ASD wait years between when autism is suspected in the primary care setting and when definitive diagnosis and treatment begin Delayed and missed diagnoses are particularly problematic for low-income and racialethnic minority children in the US who experience higher rates of these adverse outcomes

The Autism Access Link to Early Referral and Treatment Autism ALERT program is a statewide monitoring and case management program to accelerate access to ASD diagnosis and treatment among children with suspected ASD the primary care setting The system will reduce the time between identification of suspected ASD in the primary care setting and establishment of ASD diagnosis and treatment services by reducing family barriers to care decreasing primary care provider burdens and simplifying referral processes Following an initial pilot trial we propose implementing the intervention to families in the Portland metropolitan area before expanding the program elsewhere in the state The program will be available to any Oregon child age 12-54 months regardless of health system or payor type Autism ALERT will become part of the Help Me Grow national network which gives it potential for statewide and national spread

In this proposed research we will undertake a single arm implementationeffectiveness trial in which the program will be tested throughout the state of Oregon beginning in the Portland metropolitan area In the long term this research will result in a sustainable evidence-based statewide and ultimately national monitoring system children with suspected ASD

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None