Autism Spectrum DisorderAutism ALERTNCT04861740
Autism Access Link for Early Referral and Treatment
A study testing Autism ALERT and Screening Intervention in people with Autism Spectrum Disorder, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Autism Access Link for Early Referral and Treatment [ALERT], the intervention proposed in this application, is a novel state-wide referral and case management platform that PCPs can activate to ensure that a child with suspected ASD receives all necessary ASD diagnosis and treatment resources in a single referral… Read more about this study
- Who is it for?
- Ages 12 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Autism ALERT and Screening Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 4 Jan 2024
- 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 12 to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child's primary care provider suspects the child has ASD, child is patient at one of the study clinics, child age 12 to 54 months, family speaks English or Spanish, no prior ASD medical diagnosis or ASD diagnostic evaluation
Who cannot join
- Previous diagnosis of ASD or prior diagnostic evaluation for ASD.
Trial locations and contacts
1 site in 1 country.
About this study
Autism Access Link for Early Referral and Treatment [ALERT], the intervention proposed in this application, is a novel state-wide referral and case management platform that PCPs can activate to ensure that a child with suspected ASD receives all necessary ASD diagnosis and treatment resources in a single referral, radically simplifying a complex diagnostic and treatment process. We hypothesize that Autism ALERT will have strong acceptability and high rates of use among primary care providers as well as among diverse low-income patients of children at risk for ASD, and that we will see higher rates of child ASD educational evaluations within six months, and shorter time between referral and ASD treatment, compared with our control.
Read the detailed description
Though significant research effort has focused on autism spectrum disorder (ASD) screening, less attention has been devoted to optimizing follow-up of children who are subsequently identified as at-risk. Despite increases in ASD screening rates, many children with ASD wait years between when autism is suspected in the primary care setting and when definitive diagnosis and treatment begin. Delayed and missed diagnoses are particularly problematic for low-income and racial/ethnic minority children in the US, who experience higher rates of these adverse outcomes. In this project, we propose to pilot test Autism Access Link to Early Referral and Treatment (Autism ALERT), a statewide monitoring and case management program to accelerate access to ASD diagnosis and treatment among children with suspected ASD the primary care setting. The system will reduce the time between identification of suspected ASD in the primary care setting and establishment of ASD diagnosis and treatment services, by reducing family barriers to care, decreasing primary care provider burdens, and simplifying referral processes. The program will be available to any Oregon child age 12-54 months, regardless of health system or payor type. Autism ALERT will become part of the Help Me Grow national network, which gives it potential for statewide and national spread. In this proposed research, we will pilot test Autism ALERT by comparing it to an existing ASD screening intervention in 6 Oregon primary care practices. Primary goals of this pilot project are to assess feasibility and acceptability of Autism ALERT for primary care providers and families, to test the mechanism of action of Autism ALERT, to pilot test efficacy in reducing time to autism diagnosis and treatment, and to test fidelity of protocol implementation. If successful, this project will be expanded into an implementation/effectiveness R01 in which the program will be tested throughout the state of Oregon. In the long term, this research will result in a sustainable, evidence-based statewide and ultimately national monitoring system children with suspected ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Autism ALERT, Screening Intervention
- Keywords
- Autism Spectrum Disorder, Primary Care, Case Management
- 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.
Autism ALERTOther
Autism Access Link for Early Referral and Treatment [ALERT], the intervention proposed in this application, is a novel state-wide referral and case management platform that PCPs can activate to ensure that a child with suspected ASD receives all necessary ASD diagnosis and treatment resources in a single referral, radically simplifying a complex diagnostic and treatment process.
Screening InterventionOther
Also called START Autism
Autism screening intervention only.
| Study group | Role | What they receive |
|---|---|---|
| Screening + Autism ALERT | Experimental | Clinics in the intervention arm receive Autism ALERT plus an ASD screening intervention (START Autism). Receives: Other: Autism ALERT; Other: Screening Intervention |
| Screening Only | Active comparator | Clinics in the comparison intervention (control) arm receive the ASD screening intervention only (START Autism). Receives: Other: Screening Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in satisfaction with Care Coordination in general and for autism in particular
2 separate provider survey measures
Measured: At enrollment and study end (~9 months after enrollment)
Change in Parent stress
Parent Survey - Parenting Stress Index
Measured: At enrollment and 6 months after enrollment
Change in Parenting stress
Questionnaire on Resources and stress - Short Form
Measured: At enrollment and 6 months after enrollment
Change in Family Empowerment
Parent Survey - Family Empowerment Scale, Family Subscale
Measured: At enrollment and 6 months after enrollment
Change in Family Centered and Coordinated Care
Parent Survey - Items from National Survey of Children's Health, Medical Home item set
Measured: At enrollment and 6 months after enrollment
Family Satisfaction with Program
Parent Survey items - Satisfaction with Interpersonal Relationship with Navigator (PSN-I), Client Satisfaction Questionnaire - 8
Measured: 6 months after enrollment - Autism ALERT + Screening arm only
% referred to program who complete an ASD educational evaluation within 6 months
Administrative data - Oregon Early Intervention/Early Childhood Special Ed (EI/ECSE) database
Measured: 6 months after enrollment
Time from EI/ECSE referral to ASD treatment in EI/ECSE, among children with ASD
Administrative data - Oregon EI/ECSE database
Measured: measured 9 months after enrollment
Family self-reported ASD knowledge
5-item survey measure
Measured: At enrollment and 9 months after enrollment
Change in provider self-efficacy about autism management
1-item survey measure
Measured: At enrollment and at study end (~9 months after enrollment)
Secondary outcomes (7)
Change in provider autism paperwork burden
Provider survey item
Measured: At enrollment and at study end (~9 months after enrollment)
Time from EI/ECSE referral to evaluation among children with ASD
Administrative data - Oregon EI/ECSE database
Measured: measured 9 months after enrollment
Age of EI/ECSE educational determination, among children with ASD
Administrative data - Oregon EI/ECSE database
Measured: measured 9 months after enrollment
% with ASD determination receiving ASD services 6 months after enrollment
Administrative data - Oregon EI/ECSE database
Measured: measured 9 months after enrollment
monthly service hours among children with ASD 6 months after enrollment
Administrative data - Oregon EI/ECSE database
Measured: measured 9 months after enrollment
age of ASD medical diagnosis among children on Medicaid
Administrative data - Medicaid claims
Measured: Measured 1 year after study enrollment
% with ASD medical diagnosis receiving ASD therapy 6 months after enrollment, among children on Medicaid
Administrative data - Medicaid claims
Measured: Measured 1 year after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Sep 2020
- Primary completion1 Apr 2023
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Model description
- We propose a pilot clustered interventional trial with two arms. Clinics in the intervention arm (Screening + Autism ALERT) receive Autism ALERT plus an ASD screening intervention, and clinics in the comparison intervention arm (Screening Only) receive the ASD screening intervention only (START Autism). As this is a pilot trial, primary outcomes of interest are feasibility and acceptability. We will additionally assess mechanism of outcome, preliminary efficacy, and protocol fidelity. Feasibility and acceptability will be assessed in intervention clinics. Mechanism of action and preliminary efficacy will be assessed by comparing intervention to control clinics. Fidelity is assessed in both arms. We will pilot test Autism ALERT in 6 safety-net primary care clinics in Oregon.
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, Providence Health & Services
- Responsible party
- Principal investigator, Katharine Zuckerman, MD MPH, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861740
- Sponsor's protocol ID
- 00001
- Acronym
- Autism ALERT
- Status last verified
- Mar 2025
- First submitted
- 7 Apr 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share data through the NIMH Data Archive as required by the grant.
Publications
Zuckerman KE, Owens Reinitz M, Solgi M, Feryn A, Tae M, Cavanaugh P, Raja-Vora J, Fombonne E. Preliminary Efficacy of Telehealth Family Navigation for Early Autism Services Access. J Autism Dev Disord. 2025 Dec 29:10.1007/s10803-025-07189-w. doi: 10.1007/s10803-025-07189-w. Online ahead of print.
PubMed 41460569
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Access Link for Early Referral and Treatment
- ClinicalTrials.gov ID
- NCT04861740
- Acronym / sponsor ID
- Autism ALERT / 00001
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Primary Care, Case Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Boston Medical Center, Providence Health & Services
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 27 Apr 2021 (actual)
- 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.
Autism Access Link for Early Referral and Treatment [ALERT], the intervention proposed in this application, is a novel state-wide referral and case management platform that PCPs can activate to ensure that a child with suspected ASD receives all necessary ASD diagnosis and treatment resources in a single referral, radically simplifying a complex diagnostic and treatment process. We hypothesize that Autism ALERT will have strong acceptability and high rates of use among primary care providers as well as among diverse low-income patients of children at risk for ASD, and that we will see higher rates of child ASD educational evaluations within six months, and shorter time between referral and ASD treatment, compared with our control.
Detailed description
Though significant research effort has focused on autism spectrum disorder (ASD) screening, less attention has been devoted to optimizing follow-up of children who are subsequently identified as at-risk. Despite increases in ASD screening rates, many children with ASD wait years between when autism is suspected in the primary care setting and when definitive diagnosis and treatment begin. Delayed and missed diagnoses are particularly problematic for low-income and racial/ethnic minority children in the US, who experience higher rates of these adverse outcomes. In this project, we propose to pilot test Autism Access Link to Early Referral and Treatment (Autism ALERT), a statewide monitoring and case management program to accelerate access to ASD diagnosis and treatment among children with suspected ASD the primary care setting. The system will reduce the time between identification of suspected ASD in the primary care setting and establishment of ASD diagnosis and treatment services, by reducing family barriers to care, decreasing primary care provider burdens, and simplifying referral processes. The program will be available to any Oregon child age 12-54 months, regardless of health system or payor type. Autism ALERT will become part of the Help Me Grow national network, which gives it potential for statewide and national spread. In this proposed research, we will pilot test Autism ALERT by comparing it to an existing ASD screening intervention in 6 Oregon primary care practices. Primary goals of this pilot project are to assess feasibility and acceptability of Autism ALERT for primary care providers and families, to test the mechanism of action of Autism ALERT, to pilot test efficacy in reducing time to autism diagnosis and treatment, and to test fidelity of protocol implementation. If successful, this project will be expanded into an implementation/effectiveness R01 in which the program will be tested throughout the state of Oregon. In the long term, this research will result in a sustainable, evidence-based statewide and ultimately national monitoring system children with suspected ASD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We propose a pilot clustered interventional trial with two arms. Clinics in the intervention arm (Screening + Autism ALERT) receive Autism ALERT plus an ASD screening intervention, and clinics in the comparison intervention arm (Screening Only) receive the ASD screening intervention only (START Autism). As this is a pilot trial, primary outcomes of interest are feasibility and acceptability. We will additionally assess mechanism of outcome, preliminary efficacy, and protocol fidelity. Feasibility and acceptability will be assessed in intervention clinics. Mechanism of action and preliminary efficacy will be assessed by comparing intervention to control clinics. Fidelity is assessed in both arms. We will pilot test Autism ALERT in 6 safety-net primary care clinics in Oregon.
| Arm | Type | Receives |
|---|---|---|
| Screening + Autism ALERT | Experimental | Other: Autism ALERT, Other: Screening InterventionClinics in the intervention arm receive Autism ALERT plus an ASD screening intervention (START Autism). |
| Screening Only | Active comparator | Other: Screening InterventionClinics in the comparison intervention (control) arm receive the ASD screening intervention only (START Autism). |
Who may qualify
- Ages
- 12 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- child's primary care provider suspects the child has ASD, child is patient at one of the study clinics, child age 12 to 54 months, family speaks English or Spanish, no prior ASD medical diagnosis or ASD diagnostic evaluation
Key exclusion criteria (1 listed)
- Previous diagnosis of ASD or prior diagnostic evaluation for ASD.
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 |
|---|---|---|
| Autism ALERTAutism Access Link for Early Referral and Treatment [ALERT], the intervention proposed in this application, is a novel state-wide referral and case management platform that PCPs can activate to ensure that a child with suspected ASD receives all necessary ASD diagnosis and treatment resources in a single referral, radically simplifying a complex diagnostic and treatment process. | Other | Screening + Autism ALERT |
| Screening InterventionAlso: START AutismAutism screening intervention only. | Other | Screening + Autism ALERT, Screening Only |
Primary outcome
Change in satisfaction with Care Coordination in general and for autism in particular
Time frame: At enrollment and study end (~9 months after enrollment)
2 separate provider survey measures
Change in Parent stress
Time frame: At enrollment and 6 months after enrollment
Parent Survey - Parenting Stress Index
Change in Parenting stress
Time frame: At enrollment and 6 months after enrollment
Questionnaire on Resources and stress - Short Form
Change in Family Empowerment
Time frame: At enrollment and 6 months after enrollment
Parent Survey - Family Empowerment Scale, Family Subscale
Change in Family Centered and Coordinated Care
Time frame: At enrollment and 6 months after enrollment
Parent Survey - Items from National Survey of Children's Health, Medical Home item set
Family Satisfaction with Program
Time frame: 6 months after enrollment - Autism ALERT + Screening arm only
Parent Survey items - Satisfaction with Interpersonal Relationship with Navigator (PSN-I), Client Satisfaction Questionnaire - 8
% referred to program who complete an ASD educational evaluation within 6 months
Time frame: 6 months after enrollment
Administrative data - Oregon Early Intervention/Early Childhood Special Ed (EI/ECSE) database
Time from EI/ECSE referral to ASD treatment in EI/ECSE, among children with ASD
Time frame: measured 9 months after enrollment
Administrative data - Oregon EI/ECSE database
Family self-reported ASD knowledge
Time frame: At enrollment and 9 months after enrollment
5-item survey measure
Change in provider self-efficacy about autism management
Time frame: At enrollment and at study end (~9 months after enrollment)
1-item survey measure
7 secondary outcomes
Change in provider autism paperwork burden
Time frame: At enrollment and at study end (~9 months after enrollment)
Time from EI/ECSE referral to evaluation among children with ASD
Time frame: measured 9 months after enrollment
Age of EI/ECSE educational determination, among children with ASD
Time frame: measured 9 months after enrollment
% with ASD determination receiving ASD services 6 months after enrollment
Time frame: measured 9 months after enrollment
monthly service hours among children with ASD 6 months after enrollment
Time frame: measured 9 months after enrollment
age of ASD medical diagnosis among children on Medicaid
Time frame: Measured 1 year after study enrollment
% with ASD medical diagnosis receiving ASD therapy 6 months after enrollment, among children on Medicaid
Time frame: Measured 1 year after study enrollment
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 21 Mar 2025.
- Derived from this study: PubMed 41460569Zuckerman KE, Owens Reinitz M, Solgi M, Feryn A, Tae M, Cavanaugh P, Raja-Vora J, Fombonne E. Preliminary Efficacy of Telehealth Family Navigation for Early Autism Services Access. J Autism Dev Disord. 2025 Dec 29:10.1007/s10803-025-07189-w. doi: 10.1007/s10803-025-07189-w. Online ahead of print.
- Individual participant dataSharing planned: Yes. We will share data through the NIMH Data Archive as required by the grant.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autism ALERT and Screening Intervention in people with Autism Spectrum Disorder, run by Oregon Health and Science University at 1 site 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 1 inclusion and 1 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in satisfaction with Care Coordination in general and for autism in particular (time frame: At enrollment and study end (~9 months after enrollment)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04861740, which also lists 1 linked publication.
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 21 Mar 2025.