Autism Access Link for Early Referral and Treatment

NCT ID: NCT04861740

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-01-04

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 patients of children at risk for ASD, and that we will see higher rates of child ASD educational evaluations within six months, and shorter time between referral and ASD treatment, compared with our control.

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. In this project, we propose to pilot test Autism Access Link to Early Referral and Treatment (Autism ALERT), 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. 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 pilot test Autism ALERT by comparing it to an existing ASD screening intervention in 6 Oregon primary care practices. Primary goals of this pilot project are to assess feasibility and acceptability of Autism ALERT for primary care providers and families, to test the mechanism of action of Autism ALERT, to pilot test efficacy in reducing time to autism diagnosis and treatment, and to test fidelity of protocol implementation. If successful, this project will be expanded into an implementation/effectiveness R01 in which the program will be tested throughout the state of Oregon. 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

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Screening + Autism ALERT

Clinics in the intervention arm receive Autism ALERT plus an ASD screening intervention (START Autism).

Group Type: EXPERIMENTAL

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.

Screening Intervention

Intervention Type: OTHER

Autism screening intervention only.

Screening Only

Clinics in the comparison intervention (control) arm receive the ASD screening intervention only (START Autism).

Group Type: ACTIVE_COMPARATOR

Screening Intervention

Intervention Type: OTHER

Autism screening intervention only.

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

Screening Intervention

Autism screening intervention only.

Intervention Type: OTHER

Other Intervention Names

START Autism

Eligibility Criteria

Inclusion Criteria

child's primary care provider suspects the child has ASD, child is 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: Yes

Sponsors

Boston Medical Center

OTHER

Sponsor Role: collaborator

Providence Health & Services

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Katharine Zuckerman, MD MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ohsu Cdrc

Portland, Oregon, United States

Countries

United States

Other Identifiers

00001

Identifier Type: -

Identifier Source: org_study_id