Autism ALERT Expansion

Autism Access Link for Early Referral and Treatment Expansion

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Autism ALERT

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Ohsu Cdrc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Families with a child aged 12-54 months who are suspected to have autism by a primary care provider who have not received a medical autism diagnosis or a prior diagnostic autism evaluation. Initially restricted to residents of the Multnomah, Clackamas, or Washington counties of Oregon.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: 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.; Other Names: Autism Access Link for Early Referral and Treatment [ALERT]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in satisfaction with Care Coordination in general and for autism in particular	2 separate provider survey measures	At enrollment and study end (~9 months after enrollment)
Change in Parent stress	Parent Survey - Parenting Stress Index	At enrollment and 6 months after enrollment
Change in Parenting stress	Questionnaire on Resources and stress - Short Form	At enrollment and 6 months after enrollment
Change in Family Empowerment	Parent Survey - Family Empowerment Scale, Family Subscale	At enrollment and 6 months after enrollment
Change in Family Centered and Coordinated Care	Parent Survey - Items from National Survey of Children's Health, Medical Home item set	At enrollment and 6 months after enrollment
% referred to program who complete an ASD educational evaluation within 6 months	Administrative data - Oregon Early Intervention/Early Childhood Special Ed (EI/ECSE) database	6 months after enrollment
Time from EI/ECSE referral to ASD treatment in EI/ECSE, among children with ASD	Administrative data - Oregon EI/ECSE database	measured 9 months after enrollment
Family self-reported ASD knowledge	5-item survey measure	At enrollment and 9 months after enrollment
Change in provider self-efficacy about autism management	1-item survey measure	At enrollment and at study end (~9 months after enrollment)
Family Satisfaction with Program	Parent Survey items - Satisfaction with Interpersonal Relationship with Navigator (PSN-I), Client Satisfaction Questionnaire - 8	6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in provider autism paperwork burden	Provider survey item	At enrollment and at study end (~9 months after enrollment)
Time from EI/ECSE referral to evaluation among children with ASD	Administrative data - Oregon EI/ECSE database	measured 9 months after enrollment
Age of EI/ECSE educational determination, among children with ASD	Administrative data - Oregon EI/ECSE database	measured 9 months after enrollment
% with ASD determination receiving ASD services 6 months after enrollment	Administrative data - Oregon EI/ECSE database	measured 9 months after enrollment
monthly service hours among children with ASD 6 months after enrollment	Administrative data - Oregon EI/ECSE database	measured 9 months after enrollment
age of ASD medical diagnosis among children on Medicaid	Administrative data - Medicaid claims	Measured 1 year after study enrollment
% with ASD medical diagnosis receiving ASD therapy 6 months after enrollment, among children on Medicaid	Administrative data - Medicaid claims	Measured 1 year after study enrollment

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Providence Health & Services

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Primary Care; Autism Spectrum Disorder; Case Management
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: STUDY00020673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No