Autism Access Link for Early Referral and Treatment

NCT04861740 | Completed

• 1 other identifier: 00001
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Primary Care; Case Management

Outcome Measures

Primary Outcomes (10)

• 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

• Family Satisfaction with Program

  Parent Survey items - Satisfaction with Interpersonal Relationship with Navigator (PSN-I), Client Satisfaction Questionnaire - 8

  6 months after enrollment - Autism ALERT + Screening arm only

• % 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)

Secondary Outcomes (7)

• Change in provider autism paperwork burden

  At enrollment and at study end (~9 months after enrollment)

• Time from EI/ECSE referral to evaluation among children with ASD

  measured 9 months after enrollment

• Age of EI/ECSE educational determination, among children with ASD

  measured 9 months after enrollment

• % with ASD determination receiving ASD services 6 months after enrollment

  measured 9 months after enrollment

• monthly service hours among children with ASD 6 months after enrollment

  measured 9 months after enrollment

Study Arms (2)

Screening + Autism ALERT

EXPERIMENTAL

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

Other: Autism ALERT; Other: Screening Intervention

Screening Only

ACTIVE COMPARATOR

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

Other: Screening Intervention

Interventions

Autism ALERT 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 + Autism ALERT

Screening Intervention OTHER

Autism screening intervention only.

Also known as: START Autism

Screening + Autism ALERT; Screening Only

Eligibility Criteria

• Age: 12 Months - 54 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Boston Medical Center: collaborator
• Providence Health & Services: collaborator

Study Sites (1)

Ohsu Cdrc

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Zuckerman KE, Owens Reinitz M, Solgi M, Feryn A, Tae M, Cavanaugh P, Raja-Vora J, Fombonne E. Preliminary Efficacy of Telehealth Family Navigation for Early Autism Services Access. J Autism Dev Disord. 2025 Dec 29. doi: 10.1007/s10803-025-07189-w. Online ahead of print.

  PMID: 41460569 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We propose a pilot clustered interventional trial with two arms. Clinics in the intervention arm (Screening + Autism ALERT) receive Autism ALERT plus an ASD screening intervention, and clinics in the comparison intervention arm (Screening Only) receive the ASD screening intervention only (START Autism). As this is a pilot trial, primary outcomes of interest are feasibility and acceptability. We will additionally assess mechanism of outcome, preliminary efficacy, and protocol fidelity. Feasibility and acceptability will be assessed in intervention clinics. Mechanism of action and preliminary efficacy will be assessed by comparing intervention to control clinics. Fidelity is assessed in both arms. We will pilot test Autism ALERT in 6 safety-net primary care clinics in Oregon.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 27, 2021
• Study Start: September 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: January 4, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available indefinitely starting with the conclusion of the study.

Locations

US (1)