Autism Access Link for Early Referral and Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Autism Access Link for Early Referral and Treatment

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: Autism ALERT
* Other: Screening Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 54 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening + Autism ALERT<br>Clinics in the intervention arm receive Autism ALERT plus an ASD screening intervention (START Autism). | Other: Autism ALERT<br>* 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.<br>Other: Screening Intervention<br>* Autism screening intervention only.<br>* Other names: START Autism;|
| Active Comparator: Screening Only<br>Clinics in the comparison intervention (control) arm receive the ASD screening intervention only (START Autism). | Other: Screening Intervention<br>* Autism screening intervention only.<br>* Other names: START Autism;|

What is the study measuring?
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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 | 
| 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder, Primary Care, Case Management