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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06246890
Other study ID # STUDY00020673
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 30, 2024
Est. completion date January 1, 2028

Study information

Verified date January 2024
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date January 1, 2028
Est. primary completion date January 1, 2028
Accepts healthy volunteers No
Gender All
Age group 12 Months to 54 Months
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Previous diagnosis of ASD or prior diagnostic evaluation for ASD.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Autism 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.

Locations

Country Name City State
United States Ohsu Cdrc Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Health and Science University Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in satisfaction with Care Coordination in general and for autism in particular 2 separate provider survey measures At enrollment and study end (~9 months after enrollment)
Primary Change in Parent stress Parent Survey - Parenting Stress Index At enrollment and 6 months after enrollment
Primary Change in Parenting stress Questionnaire on Resources and stress - Short Form At enrollment and 6 months after enrollment
Primary Change in Family Empowerment Parent Survey - Family Empowerment Scale, Family Subscale At enrollment and 6 months after enrollment
Primary Change in Family Centered and Coordinated Care Parent Survey - Items from National Survey of Children's Health, Medical Home item set At enrollment and 6 months after enrollment
Primary Family Satisfaction with Program Parent Survey items - Satisfaction with Interpersonal Relationship with Navigator (PSN-I), Client Satisfaction Questionnaire - 8 6 months after enrollment
Primary % referred to program who complete an ASD educational evaluation within 6 months Administrative data - Oregon Early Intervention/Early Childhood Special Ed (EI/ECSE) database 6 months after enrollment
Primary Time from EI/ECSE referral to ASD treatment in EI/ECSE, among children with ASD Administrative data - Oregon EI/ECSE database measured 9 months after enrollment
Primary Family self-reported ASD knowledge 5-item survey measure At enrollment and 9 months after enrollment
Primary Change in provider self-efficacy about autism management 1-item survey measure At enrollment and at study end (~9 months after enrollment)
Secondary Change in provider autism paperwork burden Provider survey item At enrollment and at study end (~9 months after enrollment)
Secondary Time from EI/ECSE referral to evaluation among children with ASD Administrative data - Oregon EI/ECSE database measured 9 months after enrollment
Secondary Age of EI/ECSE educational determination, among children with ASD Administrative data - Oregon EI/ECSE database measured 9 months after enrollment
Secondary % with ASD determination receiving ASD services 6 months after enrollment Administrative data - Oregon EI/ECSE database measured 9 months after enrollment
Secondary monthly service hours among children with ASD 6 months after enrollment Administrative data - Oregon EI/ECSE database measured 9 months after enrollment
Secondary age of ASD medical diagnosis among children on Medicaid Administrative data - Medicaid claims Measured 1 year after study enrollment
Secondary % with ASD medical diagnosis receiving ASD therapy 6 months after enrollment, among children on Medicaid Administrative data - Medicaid claims Measured 1 year after study enrollment
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