NCT02374541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

3.3 years

First QC Date

February 19, 2015

Last Update Submit

April 2, 2020

Conditions

Autism Spectrum Disorders

Keywords

Patient NavigationHealth DisparitiesCoordination of ServicesEarly Intervention (Education)Health Services AccessibilityPatient Advocacy

Outcome Measures

Primary Outcomes (1)

  • Completion of developmental evaluation / eligibility determination

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

    36 months of age

Secondary Outcomes (9)

  • Individualized Family Service Plan (IFSP) development

    36 months of age

  • Age at Individualized Family Service Plan (IFSP) development

    36 months of age

  • Time to Individualized Family Service Plan (IFSP) development

    36 months of age

  • Initiation of indicated early intervention (EI) services

    36 months of age

  • Age at initiation of indicated early intervention services

    36 months of age

  • +4 more secondary outcomes

Other Outcomes (2)

  • Engagement in early intervention services for at least 3 months after initiation

    36 months of age

  • Receipt of Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) Follow-up Interview

    36 months of age

Study Arms (2)

Patient Navigation

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Patient NavigationBEHAVIORAL

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.

Also known as: Autism Patient Navigation
Patient Navigation

Eligibility Criteria

Age16 Months - 32 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Colorado School of Public Health, University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Carolyn DiGuiseppi, MD, PhD

    Colorado School of Public Health, University of Colorado Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 2, 2015

Study Start

February 16, 2015

Primary Completion

May 31, 2018

Study Completion

November 21, 2018

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)