Autism Spectrum DisordersSaLSANCT02374541
Screening and Linkage to Services for Autism
A study testing Patient Navigation in people with Autism Spectrum Disorders, run by University of Colorado, Denver at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 32 months
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Feb 2015to 21 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 32 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Existing diagnosis of autism spectrum disorder
- Sibling of enrolled subject
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Colorado School of Public Health, University of Colorado Denver
Aurora, Colorado, 80045
University of Colorado
Aurora, Colorado, 80045
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Patient Navigation
- Keywords
- Patient Navigation, Health Disparities, Coordination of Services, Early Intervention (Education), Health Services Accessibility, Patient Advocacy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
Also called Autism 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient Navigation |
| Control | No intervention | Standard referral for diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of developmental evaluation / eligibility determination
Indicated developmental evaluation (aka eligibility determination) completed (Yes/No)
Measured: 36 months of age
Secondary outcomes (9)
Individualized Family Service Plan (IFSP) development
Documented development of indicated IFSP (Yes/No)
Measured: 36 months of age
Age at Individualized Family Service Plan (IFSP) development
Age at indicated IFSP development (months)
Measured: 36 months of age
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)
Measured: 36 months of age
Initiation of indicated early intervention (EI) services
Initiation of at least one indicated EI service (Yes/No)
Measured: 36 months of age
Age at initiation of indicated early intervention services
Age at initiation of any indicated EI service (months)
Measured: 36 months of age
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)
Measured: 36 months of age
Referral for developmental evaluation / eligibility determination
Referral for developmental evaluation / eligibility determination made (yes/no)
Measured: 36 months of age
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)
Measured: 36 months of age
Age at referral for and implementation of developmental evaluation / eligibility determination
Age at referral (months) and age at completion of evaluation (months)
Measured: 36 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study start16 Feb 2015
- Primary completion31 May 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health and Hospital Authority, Rocky Mountain Human Services, El Grupo Vida
- Responsible party
- Sponsor
- Investigators
- Carolyn DiGuiseppi, MD, PhD, Principal investigator, Colorado School of Public Health, University of Colorado Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374541
- Sponsor's protocol ID
- 14-1728
- Other IDs
- R40MC27702
- Acronym
- SaLSA
- Status last verified
- Apr 2020
- First submitted
- 19 Feb 2015
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Linkage to Services for Autism
- ClinicalTrials.gov ID
- NCT02374541
- Acronym / sponsor ID
- SaLSA / 14-1728
- Conditions
- Autism Spectrum Disorders
- Keywords
- Patient Navigation, Health Disparities, Coordination of Services, Early Intervention (Education), Health Services Accessibility, Patient Advocacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Denver Health and Hospital Authority, Rocky Mountain Human Services, El Grupo Vida
- Study start
- 16 Feb 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation | Experimental | Behavioral: Patient NavigationAssistance from Autism Patient Navigator (APN) to obtain diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services. |
| Control | No intervention | –Standard referral for diagnostic evaluation / eligibility determination for possible autism spectrum disorder and, if indicated, early intervention services. |
Who may qualify
- Ages
- 16 to 32 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Existing diagnosis of autism spectrum disorder
- Sibling of enrolled subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigationAlso: Autism Patient NavigationThe 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. | Behavioural | Patient Navigation |
Primary outcome
Completion of developmental evaluation / eligibility determination
Time frame: 36 months of age
Indicated developmental evaluation (aka eligibility determination) completed (Yes/No)
9 secondary outcomes
Individualized Family Service Plan (IFSP) development
Time frame: 36 months of age
Age at Individualized Family Service Plan (IFSP) development
Time frame: 36 months of age
Time to Individualized Family Service Plan (IFSP) development
Time frame: 36 months of age
Initiation of indicated early intervention (EI) services
Time frame: 36 months of age
Age at initiation of indicated early intervention services
Time frame: 36 months of age
Time to initiation of indicated early intervention services
Time frame: 36 months of age
Referral for developmental evaluation / eligibility determination
Time frame: 36 months of age
Time to referral for and implementation of developmental evaluation / eligibility determination
Time frame: 36 months of age
Age at referral for and implementation of developmental evaluation / eligibility determination
Time frame: 36 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn DiGuiseppi, MD, PhD principal investigator
Colorado School of Public Health, University of Colorado Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation in people with Autism Spectrum Disorders, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of developmental evaluation / eligibility determination (time frame: 36 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.