Screening and Linkage to Services for Autism

Not Applicable

Completed

• Conditions: Autism Spectrum Disorders
• Interventions: Behavioral: Patient Navigation

• Registration Number: NCT02374541
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-02-16
• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-02
• Primary Completion: 2018-05-31
• Study Completion: 2018-11-21
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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

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Exclusion Criteria

• Existing diagnosis of autism spectrum disorder
• Sibling of enrolled subject

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Navigation	Patient Navigation	Assistance from Autism Patient Navigator (APN) to obtain diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services.

Primary Outcome Measures

Name	Time	Method
Completion of developmental evaluation / eligibility determination	36 months of age	Indicated developmental evaluation (aka eligibility determination) completed (Yes/No)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States

Colorado School of Public Health, University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States