Autism ALERT Expansion

NCT06246890 | Active Not Recruiting

• 1 other identifier: STUDY00020673
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Primary Care; Case Management

Outcome Measures

Primary Outcomes (10)

• 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)

• Change in Parent stress

  Parent Survey - Parenting Stress Index

  At enrollment and 6 months after enrollment

• Change in Parenting stress

  Questionnaire on Resources and stress - Short Form

  At enrollment and 6 months after enrollment

• Change in Family Empowerment

  Parent Survey - Family Empowerment Scale, Family Subscale

  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

  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

  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

  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 9 months after enrollment

• Family self-reported ASD knowledge

  5-item survey measure

  At enrollment and 9 months after enrollment

• Change in provider self-efficacy about autism management

  1-item survey measure

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

Secondary Outcomes (7)

• Change in provider autism paperwork burden

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

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

  measured 9 months after enrollment

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

  measured 9 months after enrollment

• % with ASD determination receiving ASD services 6 months after enrollment

  measured 9 months after enrollment

• monthly service hours among children with ASD 6 months after enrollment

  measured 9 months after enrollment

Study Arms (1)

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

Other: Autism ALERT

Interventions

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.

Also known as: Autism Access Link for Early Referral and Treatment [ALERT]

Screening + Autism ALERT

Eligibility Criteria

• Age: 12 Months - 54 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• \- Previous diagnosis of ASD or prior diagnostic evaluation for ASD.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Providence Health & Services: collaborator

Study Sites (1)

Ohsu Cdrc

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics; Caffeine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: January 30, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 7, 2024

Record last verified: 2024-01

Locations

US (1)