Screening and Linkage to Services for Autism

Autism Spectrum Disorders Clinical Trial

— SaLSA  

Official title:

Screening and Linkage to Services for Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374541
• Other study ID #: 14-1728
• Secondary ID: R40MC27702
• Status: Completed
• Phase: N/A
• Start date: February 16, 2015
• Est. completion date: November 21, 2018

Study information

• Verified date: April 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: November 21, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Months to 32 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Colorado School of Public Health, University of Colorado Denver	Aurora	Colorado
United States	University of Colorado	Aurora	Colorado
United States	Denver Health and Hospital Authority	Denver	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Denver Health and Hospital Authority, El Grupo Vida, Rocky Mountain Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Completion of developmental evaluation / eligibility determination	Indicated developmental evaluation (aka eligibility determination) completed (Yes/No)	36 months of age
Secondary	Individualized Family Service Plan (IFSP) development	Documented development of indicated IFSP (Yes/No)	36 months of age
Secondary	Age at Individualized Family Service Plan (IFSP) development	Age at indicated IFSP development (months)	36 months of age
Secondary	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
Secondary	Initiation of indicated early intervention (EI) services	Initiation of at least one indicated EI service (Yes/No)	36 months of age
Secondary	Age at initiation of indicated early intervention services	Age at initiation of any indicated EI service (months)	36 months of age
Secondary	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
Secondary	Referral for developmental evaluation / eligibility determination	Referral for developmental evaluation / eligibility determination made (yes/no)	36 months of age
Secondary	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
Secondary	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