- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02409303
An SRT Model for Early Access to ASD Intervention
A Screen-Refer-Treat (SRT) Model to Promote Earlier Access to ASD Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Washington
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Seattle, Washington, United States, 98195
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
PCPs:
-PCPs must work at a participating primary care practice.
EI Providers:
-EI providers must work at a participating early intervention agency.
Caregivers and Toddlers:
To be categorized as part of the ASD Concerns Sample recruited from PCP offices:
- Toddlers must demonstrate ASD risk/concern by meeting at least one of the following criteria: (1) behaviorally-based caregiver concerns about the presence of ASD; (2) behaviorally-based PCP concerns about the presence of ASD; (3) having an older sibling with an ASD diagnosis; or (4) screening positive for ASD on a validated screening tool.
- Toddlers must be between 16-20 months of age
To be categorized as part of the No ASD Concerns Sample recruited from PCP offices:
- Toddlers must be between 16-20 months of age
To be categorized as part of the ASD Dx/ASD Concerns Sample recruited from EI agencies:
- Toddlers must demonstrate ASD risk/concern by meeting at least one of the following criteria: (1) behaviorally-based caregiver concerns about the presence of ASD; (2) behaviorally-based PCP concerns about the presence of ASD; (3) having an older sibling with an ASD diagnosis; (4) screening positive for ASD on a validated screening tool; or (5) parent-report of an ASD diagnosis.
- Toddlers must be between 16-30 months of age
Exclusion Criteria:
-There are no exclusion criteria for PCPs or EI providers.
Caregivers/toddlers meeting the inclusion criteria described above will be excluded if the caregiver:
-reports that the toddler has any severe visual, auditory, or physical impairments, and/or serious medical, genetic, or neurological disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Screen-Refer-Treat Intervention
PCPs and EI Providers receive training workshops on validated, evidence-based practices (i.e., Online M-CHAT-R/F, STAT, and RIT) and then receive TA (i.e., Screen-Refer-Treat Intervention).
At the county level, providers are randomized to the order/timing at which they will receive this system intervention
|
This intervention is healthcare system intervention that trains providers on validated screening tools (Online M-CHAT-R/F and STAT) and an evidence-based behavioral intervention (RIT).
PCPs receive a 2-hour training workshop on the Online M-CHAT-R/F and EI Providers receive 2 day-long training workshops, one on the STAT/expedited assessment and one RIT.
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No Intervention: Control
No intervention received.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in rates of ASD screening by PCPs at the 18-month Well-Child visit from baseline (pre-SRT intervention) to post-SRT intervention
Time Frame: 5 times over 4 years
|
PCP self-report
|
5 times over 4 years
|
Change in rates of referral for early intervention services by PCPs at the 18-month Well-Child visit from baseline (pre-SRT intervention) to post-SRT intervention
Time Frame: 5 times over 4 years
|
PCP self-report
|
5 times over 4 years
|
Change in percent of toddlers at risk for ASD recieving ASD-specialized behavioral intervention before 24 months from baseline (pre-SRT intervention) to post-SRT intervention
Time Frame: Every 3 months until toddlers turn 36 months of age
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Caregiver report
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Every 3 months until toddlers turn 36 months of age
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Change in average age at which children receive an ASD diagnosis from baseline (pre-SRT intervention) to post-SRT intervention
Time Frame: Every 3 months until toddlers turn 36 months of age
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Caregiver report
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Every 3 months until toddlers turn 36 months of age
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Change in levels of parenting stress, parenting efficacy, health quality of life, and satisfaction with the healthcare system from baseline (pre-SRT intervention) to post-SRT intervention
Time Frame: Every 3 months until children turn 36 months of age
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Caregiver self-report
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Every 3 months until children turn 36 months of age
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Change in levels of pivotal social-communicative behaviors in toddlers at risk for ASD from baseline (pre-SRT intervention) to post-SRT intervention
Time Frame: Every 3 months until children turn 36 months of age
|
Caregiver report
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Every 3 months until children turn 36 months of age
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Steinman KJ, Stone WL, Ibanez LV, Attar SM. Reducing Barriers to Autism Screening in Community Primary Care: A Pragmatic Trial Using Web-Based Screening. Acad Pediatr. 2022 Mar;22(2):263-270. doi: 10.1016/j.acap.2021.04.017. Epub 2021 Apr 23.
- Ibanez LV, Stoep AV, Myers K, Zhou C, Dorsey S, Steinman KJ, Stone WL. Promoting early autism detection and intervention in underserved communities: study protocol for a pragmatic trial using a stepped-wedge design. BMC Psychiatry. 2019 Jun 7;19(1):169. doi: 10.1186/s12888-019-2150-3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 47892
- R01MH104302-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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