Clinical trial NCT02374541: Screening and Linkage to Services for Autism
Official title: Screening and Linkage to Services for Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: Patient Navigation
Health Disparities
Coordination of Services
Early Intervention (Education)
Health Services Accessibility
Patient Advocacy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Denver Health and Hospital Authority
name: Rocky Mountain Human Services
name: El Grupo Vida
First posted: 2015-03-02
Enrollment: 305
Sex: ALL
Minimum age (years): 16
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion of developmental evaluation / eligibility determination
timeFrame: 36 months of age
Secondary outcomes:
measure: Individualized Family Service Plan (IFSP) development
timeFrame: 36 months of age
measure: Age at Individualized Family Service Plan (IFSP) development
timeFrame: 36 months of age
measure: Time to Individualized Family Service Plan (IFSP) development
timeFrame: 36 months of age
measure: Initiation of indicated early intervention (EI) services
timeFrame: 36 months of age
measure: Age at initiation of indicated early intervention services
timeFrame: 36 months of age
measure: Time to initiation of indicated early intervention services
timeFrame: 36 months of age
measure: Referral for developmental evaluation / eligibility determination
timeFrame: 36 months of age
measure: Time to referral for and implementation of developmental evaluation / eligibility determination
timeFrame: 36 months of age
measure: Age at referral for and implementation of developmental evaluation / eligibility determination
timeFrame: 36 months of age
Other outcomes:
measure: Engagement in early intervention services for at least 3 months after initiation
timeFrame: 36 months of age
measure: Receipt of Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) Follow-up Interview
timeFrame: 36 months of age
Locations:
city: Aurora
country: United States
facility: Colorado School of Public Health, University of Colorado Denver
state: Colorado
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
Study officials:
affiliation: Colorado School of Public Health, University of Colorado Denver
name: Carolyn DiGuiseppi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: