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Screening and Linkage to Services for Autism (SaLSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02374541
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : April 6, 2020
Sponsor:
Collaborators:
Denver Health and Hospital Authority
Rocky Mountain Human Services
El Grupo Vida
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Behavioral: Patient Navigation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Screening and Linkage to Services for Autism
Actual Study Start Date : February 16, 2015
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : November 21, 2018

Resource links provided by the National Library of Medicine


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 Name: Autism Patient Navigation

No Intervention: Control
Standard referral for diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services.



Primary Outcome Measures :
  1. Completion of developmental evaluation / eligibility determination [ Time Frame: 36 months of age ]
    Indicated developmental evaluation (aka eligibility determination) completed (Yes/No)


Secondary Outcome Measures :
  1. Individualized Family Service Plan (IFSP) development [ Time Frame: 36 months of age ]
    Documented development of indicated IFSP (Yes/No)

  2. Age at Individualized Family Service Plan (IFSP) development [ Time Frame: 36 months of age ]
    Age at indicated IFSP development (months)

  3. Time to Individualized Family Service Plan (IFSP) development [ Time Frame: 36 months of age ]
    Time from initial positive Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) screen to indicated IFSP development (days)

  4. Initiation of indicated early intervention (EI) services [ Time Frame: 36 months of age ]
    Initiation of at least one indicated EI service (Yes/No)

  5. Age at initiation of indicated early intervention services [ Time Frame: 36 months of age ]
    Age at initiation of any indicated EI service (months)

  6. Time to initiation of indicated early intervention services [ Time Frame: 36 months of age ]
    Time from initial positive Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) screen to initiation of any indicated EI service (days)

  7. Referral for developmental evaluation / eligibility determination [ Time Frame: 36 months of age ]
    Referral for developmental evaluation / eligibility determination made (yes/no)

  8. Time to referral for and implementation of developmental evaluation / eligibility determination [ Time Frame: 36 months of age ]
    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)

  9. Age at referral for and implementation of developmental evaluation / eligibility determination [ Time Frame: 36 months of age ]
    Age at referral (months) and age at completion of evaluation (months)


Other Outcome Measures:
  1. Engagement in early intervention services for at least 3 months after initiation [ Time Frame: 36 months of age ]
    At least one indicated early intervention service received 3 or more months after initiation of EI services (Yes/No)

  2. Receipt of Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) Follow-up Interview [ Time Frame: 36 months of age ]
    Receipt of indicated Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT-R/F) (Yes/No)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Months to 32 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374541


Locations
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United States, Colorado
Colorado School of Public Health, University of Colorado Denver
Aurora, Colorado, United States, 80045
University of Colorado
Aurora, Colorado, United States, 80045
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Sponsors and Collaborators
University of Colorado, Denver
Denver Health and Hospital Authority
Rocky Mountain Human Services
El Grupo Vida
Investigators
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Principal Investigator: Carolyn DiGuiseppi, MD, PhD Colorado School of Public Health, University of Colorado Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02374541    
Other Study ID Numbers: 14-1728
R40MC27702 ( Other Grant/Funding Number: Health Resources and Services Administration )
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Patient Navigation
Health Disparities
Coordination of Services
Early Intervention (Education)
Health Services Accessibility
Patient Advocacy
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders