Screening and Linkage to Services for Autism (SaLSA)

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorders
• Intervention / Treatment: Behavioral: Patient Navigation

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 Type: Interventional
• Enrollment (Actual): 305
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Aurora, Colorado, United States, 80045
      • Colorado School of Public Health, University of Colorado Denver
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospital Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Patient 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.; Other Names: Autism Patient Navigation
No Intervention: Control; Standard referral for diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in early intervention services for at least 3 months after initiation	At least one indicated early intervention service received 3 or more months after initiation of EI services (Yes/No)	36 months of age
Receipt of Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) Follow-up Interview	Receipt of indicated Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT-R/F) (Yes/No)	36 months of age

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Denver Health and Hospital Authority; Rocky Mountain Human Services; El Grupo Vida
• Investigators: Principal Investigator: Carolyn DiGuiseppi, MD, PhD, Colorado School of Public Health, University of Colorado Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2015
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): November 21, 2018

Study Registration Dates

• First Submitted: February 19, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Patient Navigation; Health Disparities; Health Services Accessibility; Coordination of Services; Early Intervention (Education); Patient Advocacy
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 14-1728; R40MC27702 (Other Grant/Funding Number: Health Resources and Services Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO