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Screening and Linkage to Services for Autism (SaLSA)

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorders focused on measuring Patient Navigation, Health Disparities, Coordination of Services, Early Intervention (Education), Health Services Accessibility, Patient Advocacy

Eligibility Criteria

16 Months - 32 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Colorado School of Public Health, University of Colorado Denver
  • University of Colorado
  • Denver Health and Hospital Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Navigation

Control

Arm Description

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

Standard referral for diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services.

Outcomes

Primary Outcome Measures

Completion of developmental evaluation / eligibility determination
Indicated developmental evaluation (aka eligibility determination) completed (Yes/No)

Secondary Outcome Measures

Individualized Family Service Plan (IFSP) development
Documented development of indicated IFSP (Yes/No)
Age at Individualized Family Service Plan (IFSP) development
Age at indicated IFSP development (months)
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)
Initiation of indicated early intervention (EI) services
Initiation of at least one indicated EI service (Yes/No)
Age at initiation of indicated early intervention services
Age at initiation of any indicated EI service (months)
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)
Referral for developmental evaluation / eligibility determination
Referral for developmental evaluation / eligibility determination made (yes/no)
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)
Age at referral for and implementation of developmental evaluation / eligibility determination
Age at referral (months) and age at completion of evaluation (months)

Full Information

First Posted
February 19, 2015
Last Updated
April 2, 2020
Sponsor
University of Colorado, Denver
Collaborators
Denver Health and Hospital Authority, Rocky Mountain Human Services, El Grupo Vida
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1. Study Identification

Unique Protocol Identification Number
NCT02374541
Brief Title
Screening and Linkage to Services for Autism
Acronym
SaLSA
Official Title
Screening and Linkage to Services for Autism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 16, 2015 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Denver Health and Hospital Authority, Rocky Mountain Human Services, El Grupo Vida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
Patient Navigation, Health Disparities, Coordination of Services, Early Intervention (Education), Health Services Accessibility, Patient Advocacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Navigation
Arm Type
Experimental
Arm Description
Assistance from Autism Patient Navigator (APN) to obtain diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard referral for diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Other Intervention Name(s)
Autism Patient Navigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of developmental evaluation / eligibility determination
Description
Indicated developmental evaluation (aka eligibility determination) completed (Yes/No)
Time Frame
36 months of age
Secondary Outcome Measure Information:
Title
Individualized Family Service Plan (IFSP) development
Description
Documented development of indicated IFSP (Yes/No)
Time Frame
36 months of age
Title
Age at Individualized Family Service Plan (IFSP) development
Description
Age at indicated IFSP development (months)
Time Frame
36 months of age
Title
Time to Individualized Family Service Plan (IFSP) development
Description
Time from initial positive Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) screen to indicated IFSP development (days)
Time Frame
36 months of age
Title
Initiation of indicated early intervention (EI) services
Description
Initiation of at least one indicated EI service (Yes/No)
Time Frame
36 months of age
Title
Age at initiation of indicated early intervention services
Description
Age at initiation of any indicated EI service (months)
Time Frame
36 months of age
Title
Time to initiation of indicated early intervention services
Description
Time from initial positive Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) screen to initiation of any indicated EI service (days)
Time Frame
36 months of age
Title
Referral for developmental evaluation / eligibility determination
Description
Referral for developmental evaluation / eligibility determination made (yes/no)
Time Frame
36 months of age
Title
Time to referral for and implementation of developmental evaluation / eligibility determination
Description
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 Frame
36 months of age
Title
Age at referral for and implementation of developmental evaluation / eligibility determination
Description
Age at referral (months) and age at completion of evaluation (months)
Time Frame
36 months of age
Other Pre-specified Outcome Measures:
Title
Engagement in early intervention services for at least 3 months after initiation
Description
At least one indicated early intervention service received 3 or more months after initiation of EI services (Yes/No)
Time Frame
36 months of age
Title
Receipt of Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) Follow-up Interview
Description
Receipt of indicated Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT-R/F) (Yes/No)
Time Frame
36 months of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Months
Maximum Age & Unit of Time
32 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn DiGuiseppi, MD, PhD
Organizational Affiliation
Colorado School of Public Health, University of Colorado Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado School of Public Health, University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Screening and Linkage to Services for Autism

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