Autism Spectrum DisorderNCT06246890
Autism ALERT Expansion
An observational study of 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 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Autism ALERT
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to 1 Jan 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child
Study population: Families with a child aged 12-54 months who are suspected to have autism by a primary care provider who have not received a medical autism diagnosis or a prior diagnostic autism evaluation. Initially restricted to residents of the Multnomah, Clackamas, or Washington counties of Oregon.
Who may be able to join
- child's primary care provider suspects the child has ASD
- child is a 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
Official title: Autism Access Link for Early Referral and Treatment Expansion
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 parents of children at risk for ASD, and that we will see increased rate of child ASD educational evaluations within six months, and shortened time between referral and ASD treatment.
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.
The Autism Access Link to Early Referral and Treatment (Autism ALERT) program is 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. Following an initial pilot trial, we propose implementing the intervention to families in the Portland metropolitan area before expanding the program elsewhere in the state. 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 undertake a single arm implementation/effectiveness trial in which the program will be tested throughout the state of Oregon, beginning in the Portland metropolitan area. 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
- 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
Also called Autism Access Link for Early Referral and Treatment [ALERT]
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening + Autism ALERT | Families with children under 54 months, without a medical ASD diagnosis, who are referred by an autism clinic or primary care provider to Autism ALERT Receives: Other: Autism ALERT |
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
% 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 posted7 Feb 2024
- Study start30 Jan 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Health & Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246890
- Sponsor's protocol ID
- STUDY00020673
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Access Link for Early Referral and Treatment Expansion
- ClinicalTrials.gov ID
- NCT06246890
- Acronym / sponsor ID
- STUDY00020673
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Primary Care, Case Management
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Providence Health & Services
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 7 Feb 2024 (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 parents of children at risk for ASD, and that we will see increased rate of child ASD educational evaluations within six months, and shortened time between referral and ASD treatment.
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.
The Autism Access Link to Early Referral and Treatment (Autism ALERT) program is 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. Following an initial pilot trial, we propose implementing the intervention to families in the Portland metropolitan area before expanding the program elsewhere in the state. 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 undertake a single arm implementation/effectiveness trial in which the program will be tested throughout the state of Oregon, beginning in the Portland metropolitan area. 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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening + Autism ALERT | – | Other: Autism ALERTFamilies with children under 54 months, without a medical ASD diagnosis, who are referred by an autism clinic or primary care provider to Autism ALERT |
Who may qualify
- Ages
- 12 to 54 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Families with a child aged 12-54 months who are suspected to have autism by a primary care provider who have not received a medical autism diagnosis or a prior diagnostic autism evaluation. Initially restricted to residents of the Multnomah, Clackamas, or Washington counties of Oregon.
Key inclusion criteria (5 listed)
- child's primary care provider suspects the child has ASD
- child is a 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 ALERTAlso: Autism Access Link for Early Referral and Treatment [ALERT]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. | Other | Screening + Autism ALERT |
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
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of 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 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
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 7 Feb 2024.