Autism ALERT Expansion

NCT ID: NCT06246890

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2028-01-01

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 racial/ethnic 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 implementation/effectiveness 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.

Conditions

Autism Spectrum Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Screening + Autism ALERT

Families with children under 54 months, without a medical ASD diagnosis, who are referred by an autism clinic or primary care provider to Autism ALERT

Autism ALERT

Intervention Type: OTHER

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.

Interventions

Autism ALERT

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.

Intervention Type: OTHER

Other Intervention Names

Autism Access Link for Early Referral and Treatment [ALERT]

Eligibility Criteria

Inclusion Criteria

• child's primary care provider suspects the child has ASD
• child is a patient at one of the study clinics
• child age 12 to 54 months
• family speaks English or Spanish
• no prior ASD medical diagnosis or ASD diagnostic evaluation

Exclusion Criteria

• Previous diagnosis of ASD or prior diagnostic evaluation for ASD.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 54 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence Health & Services

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ohsu Cdrc

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

STUDY00020673

Identifier Type: -

Identifier Source: org_study_id