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OpenTrials
Active, Not Recruiting

NCT Number: NCT06246890

Autism ALERT 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

12 month–54 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Ohsu Cdrc

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autism ALERT

Other

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 names: Autism Access Link for Early Referral and Treatment [ALERT]

Primary outcomes

  1. 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

  2. Change in Parent stress

    Time frame: At enrollment and 6 months after enrollment

    Parent Survey - Parenting Stress Index

  3. Change in Parenting stress

    Time frame: At enrollment and 6 months after enrollment

    Questionnaire on Resources and stress - Short Form

  4. Change in Family Empowerment

    Time frame: At enrollment and 6 months after enrollment

    Parent Survey - Family Empowerment Scale, Family Subscale

  5. 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

  6. 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

  7. % 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

  8. 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

  9. Family self-reported ASD knowledge

    Time frame: At enrollment and 9 months after enrollment

    5-item survey measure

  10. Change in provider self-efficacy about autism management

    Time frame: At enrollment and at study end (~9 months after enrollment)

    1-item survey measure

Secondary outcomes

  1. Change in provider autism paperwork burden

    Time frame: At enrollment and at study end (~9 months after enrollment)

    Provider survey item

  2. Time from EI/ECSE referral to evaluation among children with ASD

    Time frame: measured 9 months after enrollment

    Administrative data - Oregon EI/ECSE database

  3. Age of EI/ECSE educational determination, among children with ASD

    Time frame: measured 9 months after enrollment

    Administrative data - Oregon EI/ECSE database

  4. % with ASD determination receiving ASD services 6 months after enrollment

    Time frame: measured 9 months after enrollment

    Administrative data - Oregon EI/ECSE database

  5. monthly service hours among children with ASD 6 months after enrollment

    Time frame: measured 9 months after enrollment

    Administrative data - Oregon EI/ECSE database

  6. age of ASD medical diagnosis among children on Medicaid

    Time frame: Measured 1 year after study enrollment

    Administrative data - Medicaid claims

  7. % with ASD medical diagnosis receiving ASD therapy 6 months after enrollment, among children on Medicaid

    Time frame: Measured 1 year after study enrollment

    Administrative data - Medicaid claims

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Providence Health & Services

Registry information

Official study title

Autism Access Link for Early Referral and Treatment Expansion

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 7, 2024
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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