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Screening and Linkage to Services for Autism

Screening and Linkage to Services for Autism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02374541
Acronym
SaLSA
Enrollment
305
Registered
2015-03-02
Start date
2015-02-16
Completion date
2018-11-21
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorders

Keywords

Patient Navigation, Health Disparities, Coordination of Services, Early Intervention (Education), Health Services Accessibility, Patient Advocacy

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.

Interventions

BEHAVIORALPatient Navigation

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.

Sponsors

Denver Health and Hospital Authority
CollaboratorOTHER
Rocky Mountain Human Services
CollaboratorOTHER
El Grupo Vida
CollaboratorUNKNOWN
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Months to 32 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Completion of developmental evaluation / eligibility determination36 months of ageIndicated developmental evaluation (aka eligibility determination) completed (Yes/No)

Secondary

MeasureTime frameDescription
Individualized Family Service Plan (IFSP) development36 months of ageDocumented development of indicated IFSP (Yes/No)
Age at Individualized Family Service Plan (IFSP) development36 months of ageAge at indicated IFSP development (months)
Time to Individualized Family Service Plan (IFSP) development36 months of ageTime from initial positive Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) screen to indicated IFSP development (days)
Initiation of indicated early intervention (EI) services36 months of ageInitiation of at least one indicated EI service (Yes/No)
Age at initiation of indicated early intervention services36 months of ageAge at initiation of any indicated EI service (months)
Time to referral for and implementation of developmental evaluation / eligibility determination36 months of ageTime 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)
Age at referral for and implementation of developmental evaluation / eligibility determination36 months of ageAge at referral (months) and age at completion of evaluation (months)
Time to initiation of indicated early intervention services36 months of ageTime 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 determination36 months of ageReferral for developmental evaluation / eligibility determination made (yes/no)

Other

MeasureTime frameDescription
Engagement in early intervention services for at least 3 months after initiation36 months of ageAt least one indicated early intervention service received 3 or more months after initiation of EI services (Yes/No)
Receipt of Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) Follow-up Interview36 months of ageReceipt of indicated Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT-R/F) (Yes/No)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026