Screening and Linkage to Services for Autism

Study Overview
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Brief Summary
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The SaLSA (Screening and Linkage to Services for Autism) study will test whether patient navigation can help disadvantaged families obtain earlier diagnosis and treatment for their children who have had a positive screening test for autism spectrum disorder. Half of the families will be offered help from an autism patient navigator. The other half will receive standard care.

Detailed Description
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Despite its relatively high rate of occurrence, autism spectrum disorder (ASD) is under-diagnosed and under-treated in young children, particularly in minority and disadvantaged populations. Although screening for ASD in the primary care setting is recommended as best practice, inadequate attention has been paid to addressing important obstacles to early recognition of ASD, including barriers to referral after positive screening, completion of diagnostic evaluations, and receipt of treatment. Patient navigation was originally developed to reduce health care disparities. The patient navigator guides patients with suspicious findings (e.g., a positive screening test) through and around barriers to care to ensure timely diagnosis and treatment. Patient navigation has improved receipt of preventive care among low-income, minority children but has not been tested for improving early identification and treatment of autism spectrum disorders. The goal of this study is to test the effectiveness and feasibility of patient navigation to facilitate autism screening follow-up, diagnostic evaluation, and linkage to early intervention in a very young, disadvantaged, minority population. To increase patient navigation's potential for widespread application and public health impact, this study uses the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, a set of criteria for translating research into action, to guide planning and evaluation. The intervention's Reach, Effectiveness, Adoption, Implementation and Maintenance over time will be examined.

Official Title
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Screening and Linkage to Services for Autism

Conditions
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Autism Spectrum Disorders

Intervention / Treatment
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* Behavioral: Patient Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receives medical care at Denver Community Health Services (DCHS) clinic Positive M-CHAT screening test (score 3 or higher) between ages 16 and 30 months at DCHS Resident of City and County of Denver Exclusion Criteria: Existing diagnosis of autism spectrum disorder Sibling of enrolled subject

Ages Eligible for Study
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Minimum Age: 16 Months
Maximum Age: 32 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Navigation<br>Assistance from Autism Patient Navigator (APN) to obtain diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services. | Behavioral: Patient Navigation<br>* The Autism Patient Navigator (APN) will interview families to determine system and individual barriers facing the family at each stage of the care process. The APN will help families to overcome any identified barriers through education, coaching, social support, interpretation or translation, linkage to resources (e.g., for obtaining insurance) or logistical support (e.g., scheduling appointments, providing reminders, arranging transportation), in order to ensure timely diagnostic evaluation / eligibility determination; educate the family about autism, tests and treatments; and offer psychosocial support.<br>* Other names: Autism Patient Navigation;|
| No Intervention: Control<br>Standard referral for diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of developmental evaluation / eligibility determination | Indicated developmental evaluation (aka eligibility determination) completed (Yes/No) | 36 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individualized Family Service Plan (IFSP) development | Documented development of indicated IFSP (Yes/No) | 36 months of age | 
| Age at Individualized Family Service Plan (IFSP) development | Age at indicated IFSP development (months) | 36 months of age | 
| Time to Individualized Family Service Plan (IFSP) development | Time from initial positive Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) screen to indicated IFSP development (days) | 36 months of age | 
| Initiation of indicated early intervention (EI) services | Initiation of at least one indicated EI service (Yes/No) | 36 months of age | 
| Age at initiation of indicated early intervention services | Age at initiation of any indicated EI service (months) | 36 months of age | 
| Time to initiation of indicated early intervention services | Time from initial positive Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) screen to initiation of any indicated EI service (days) | 36 months of age | 
| Referral for developmental evaluation / eligibility determination | Referral for developmental evaluation / eligibility determination made (yes/no) | 36 months of age | 
| Time to referral for and implementation of developmental evaluation / eligibility determination | Time from initial positive Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F screen to referral (days) and to completion of evaluation (days) | 36 months of age | 
| Age at referral for and implementation of developmental evaluation / eligibility determination | Age at referral (months) and age at completion of evaluation (months) | 36 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Navigation, Health Disparities, Coordination of Services, Early Intervention (Education), Health Services Accessibility, Patient Advocacy