Autism Spectrum Disorder Clinical Trial
Official title:
Autism Access Link for Early Referral and Treatment Expansion
Verified date | January 2024 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Ohsu Cdrc | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | Providence Health & Services |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05207956 -
App for Strengthening Services In Specialized Therapeutic Support
|
N/A | |
Completed |
NCT03286621 -
Development of Eye-tracking Based Markers for Autism in Young Children
|
||
Completed |
NCT02608333 -
Efficiency of Early Intervention for Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
Active, not recruiting |
NCT06303791 -
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
|
N/A | |
Enrolling by invitation |
NCT05017779 -
A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth
|
N/A | |
Completed |
NCT04772898 -
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT04987541 -
The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder
|
N/A | |
Completed |
NCT04308915 -
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
|
N/A | |
Completed |
NCT06038435 -
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
|
N/A | |
Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
Completed |
NCT03693313 -
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
|
N/A | |
Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
Recruiting |
NCT03812068 -
Parent-mediated Developmental Behavioral Intervention
|
N/A | |
Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
Completed |
NCT02299700 -
Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
|
N/A | |
Completed |
NCT03422016 -
Electroretinogram in Autistic Spectrum Disorders
|
||
Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
Recruiting |
NCT05114538 -
Improving the Part C Early Intervention Service Delivery System for Children With ASD
|
N/A |