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Completed

NCT Number: NCT02374541

Screening and Linkage to Services for Autism

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.

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Key information

Age range

16 month–32 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado School of Public Health, University of Colorado Denver, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigation

Behavioral

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

Primary outcomes

  1. Completion of developmental evaluation / eligibility determination

    Time frame: 36 months of age

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

Secondary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Denver Health and Hospital Authority
  • El Grupo Vida
  • Rocky Mountain Human Services

Registry information

Acronym: SaLSA

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2015
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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