Clinical trial NCT06246890: Autism ALERT Expansion
Official title: Autism Access Link for Early Referral and Treatment Expansion
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Primary Care
Case Management
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Providence Health & Services
First posted: 2024-02-07
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Change in satisfaction with Care Coordination in general and for autism in particular
timeFrame: At enrollment and study end (~9 months after enrollment)
measure: Change in Parent stress
timeFrame: At enrollment and 6 months after enrollment
measure: Change in Parenting stress
timeFrame: At enrollment and 6 months after enrollment
measure: Change in Family Empowerment
timeFrame: At enrollment and 6 months after enrollment
measure: Change in Family Centered and Coordinated Care
timeFrame: At enrollment and 6 months after enrollment
measure: Family Satisfaction with Program
timeFrame: 6 months after enrollment
measure: % referred to program who complete an ASD educational evaluation within 6 months
timeFrame: 6 months after enrollment
measure: Time from EI/ECSE referral to ASD treatment in EI/ECSE, among children with ASD
timeFrame: measured 9 months after enrollment
measure: Family self-reported ASD knowledge
timeFrame: At enrollment and 9 months after enrollment
measure: Change in provider self-efficacy about autism management
timeFrame: At enrollment and at study end (~9 months after enrollment)
Secondary outcomes:
measure: Change in provider autism paperwork burden
timeFrame: At enrollment and at study end (~9 months after enrollment)
measure: Time from EI/ECSE referral to evaluation among children with ASD
timeFrame: measured 9 months after enrollment
measure: Age of EI/ECSE educational determination, among children with ASD
timeFrame: measured 9 months after enrollment
measure: % with ASD determination receiving ASD services 6 months after enrollment
timeFrame: measured 9 months after enrollment
measure: monthly service hours among children with ASD 6 months after enrollment
timeFrame: measured 9 months after enrollment
measure: age of ASD medical diagnosis among children on Medicaid
timeFrame: Measured 1 year after study enrollment
measure: % with ASD medical diagnosis receiving ASD therapy 6 months after enrollment, among children on Medicaid
timeFrame: Measured 1 year after study enrollment
Other outcomes:
Locations:
city: Portland
country: United States
facility: Ohsu Cdrc
state: Oregon
Study officials:
References: