Autism Spectrum DisorderNCT02409303
An SRT Model for Early Access to ASD Intervention
A study testing Screen-Refer-Treat Intervention in people with Autism Spectrum Disorder, run by University of Washington at 1 site in United States.
Trial summary
This project will implement and evaluate an innovative healthcare service delivery model designed to promote earlier access to specialized intervention for toddlers with ASD. The Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early identification and intervention by involving both… Read more about this study
- Who is it for?
- Ages 16 months and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Screen-Refer-Treat Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 627 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- -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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Screen-Refer-Treat (SRT) Model to Promote Earlier Access to ASD Intervention
This project will implement and evaluate an innovative healthcare service delivery model designed to promote earlier access to specialized intervention for toddlers with ASD. The Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early identification and intervention by involving both medical and EI providers, and represents a practical and sustainable strategy for bridging the gap between ASD concerns and ASD intervention.
Read the detailed description
Although caregivers often become concerned about their child by 17-19 months of age, children do not typically receive a diagnosis of autism spectrum disorder (ASD) until they are 4½ years old, or older for Hispanic families. It is now well documented that early participation in ASD-specialized intervention can lead to significant improvements in skills and behavior for toddlers with ASD. However, despite the availability of publicly funded Part C early intervention (EI) services, long waits for a formal ASD diagnosis can prevent toddlers from receiving appropriately specialized intervention during the critical birth-to-three years. In addition, caregivers concerned about ASD experience high levels of uncertainty and stress during this waiting period. This project will implement and evaluate an innovative healthcare service delivery model designed to promote earlier access to specialized intervention for toddlers with ASD. The Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early identification and intervention by involving both medical and EI providers, and represents a practical and sustainable strategy for bridging the gap between ASD concerns and ASD intervention. The SRT model, which builds on the availability of validated ASD screening tools and low-cost behaviorally-based ASD interventions, will be implemented in four diverse communities across Washington State to evaluate changes in service delivery practices for toddlers with Hispanic as well as Non-Hispanic backgrounds. The SRT model comprises three components: (1) universal ASD screening at 16-20 months and prompt referral to EI programs by primary care physicians (PCPs); (2) expedited ASD assessments within EI programs; and (3) use of an inexpensive, evidence-based ASD-specialized intervention by EI providers. An electronic version of the Modified Checklist for Autism (M-CHAT) with automated scoring that incorporates relevant follow-up questions will be provided to PCP practices, and distance coaching via telemedicine will be available to EI providers to support their ASD assessment and intervention activities. A stepped wedge cluster RCT design will be used to evaluate implementation and outcomes of the SRT model. Data on screening, referral, assessment, and intervention practices will be collected from 40 PCPs and 80 EI providers across the state prior to and following SRT implementation to identify practice changes. In addition, separate samples of caregivers of toddlers with ASD concerns (n=245) will be recruited from communities before and after SRT implementation and followed prospectively to measure differences and changes over time in caregiver wellbeing, parenting efficacy, satisfaction with healthcare systems, and toddler's social-communicative behaviors. We predict that implementation of the SRT model will be associated with higher rates of ASD screening by PCPs, earlier referral to EI programs, earlier initiation of ASD-specialized intervention, reduced time between ASD concerns and diagnosis, and improved caregiver and child outcomes.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Screen-Refer-Treat Intervention
- Keywords
- Autism Spectrum Disorder, Screening, Preventive intervention, Risk
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen-Refer-Treat InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Screen-Refer-Treat Intervention | Experimental | 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 Receives: Behavioral: Screen-Refer-Treat Intervention |
| Control | No intervention | No intervention received. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rates of ASD screening by PCPs at the 18-month Well-Child visit from baseline (pre-SRT intervention) to post-SRT intervention
PCP self-report
Measured: 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
PCP self-report
Measured: 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
Caregiver report
Measured: Every 3 months until toddlers turn 36 months of age
Change in average age at which children receive an ASD diagnosis from baseline (pre-SRT intervention) to post-SRT intervention
Caregiver report
Measured: Every 3 months until toddlers turn 36 months of age
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
Caregiver self-report
Measured: Every 3 months until children turn 36 months of age
Change in levels of pivotal social-communicative behaviors in toddlers at risk for ASD from baseline (pre-SRT intervention) to post-SRT intervention
Caregiver report
Measured: Every 3 months until children turn 36 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Wendy Stone, University of Washington
- Investigators
- Wendy L Stone, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409303
- Sponsor's protocol ID
- 47892
- Other IDs
- R01MH104302-01
- Status last verified
- Nov 2022
- First submitted
- 26 Mar 2015
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Tagavi DM, Dick CC, Attar SM, Ibanez LV, Stone WL. The implementation of the screening tool for autism in toddlers in Part C early intervention programs: An 18-month follow-up. Autism. 2023 Jan;27(1):173-187. doi: 10.1177/13623613221086329. Epub 2022 Apr 11.
PubMed 35403446Steinman 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.
PubMed 33901728Ibanez 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.
PubMed 31174514
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Screen-Refer-Treat (SRT) Model to Promote Earlier Access to ASD Intervention
- ClinicalTrials.gov ID
- NCT02409303
- Acronym / sponsor ID
- 47892
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Screening, Preventive intervention, Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital, National Institute of Mental Health (NIMH)
- Study start
- Jul 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will implement and evaluate an innovative healthcare service delivery model designed to promote earlier access to specialized intervention for toddlers with ASD. The Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early identification and intervention by involving both medical and EI providers, and represents a practical and sustainable strategy for bridging the gap between ASD concerns and ASD intervention.
Detailed description
Although caregivers often become concerned about their child by 17-19 months of age, children do not typically receive a diagnosis of autism spectrum disorder (ASD) until they are 4½ years old, or older for Hispanic families. It is now well documented that early participation in ASD-specialized intervention can lead to significant improvements in skills and behavior for toddlers with ASD. However, despite the availability of publicly funded Part C early intervention (EI) services, long waits for a formal ASD diagnosis can prevent toddlers from receiving appropriately specialized intervention during the critical birth-to-three years. In addition, caregivers concerned about ASD experience high levels of uncertainty and stress during this waiting period. This project will implement and evaluate an innovative healthcare service delivery model designed to promote earlier access to specialized intervention for toddlers with ASD. The Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early identification and intervention by involving both medical and EI providers, and represents a practical and sustainable strategy for bridging the gap between ASD concerns and ASD intervention. The SRT model, which builds on the availability of validated ASD screening tools and low-cost behaviorally-based ASD interventions, will be implemented in four diverse communities across Washington State to evaluate changes in service delivery practices for toddlers with Hispanic as well as Non-Hispanic backgrounds. The SRT model comprises three components: (1) universal ASD screening at 16-20 months and prompt referral to EI programs by primary care physicians (PCPs); (2) expedited ASD assessments within EI programs; and (3) use of an inexpensive, evidence-based ASD-specialized intervention by EI providers. An electronic version of the Modified Checklist for Autism (M-CHAT) with automated scoring that incorporates relevant follow-up questions will be provided to PCP practices, and distance coaching via telemedicine will be available to EI providers to support their ASD assessment and intervention activities. A stepped wedge cluster RCT design will be used to evaluate implementation and outcomes of the SRT model. Data on screening, referral, assessment, and intervention practices will be collected from 40 PCPs and 80 EI providers across the state prior to and following SRT implementation to identify practice changes. In addition, separate samples of caregivers of toddlers with ASD concerns (n=245) will be recruited from communities before and after SRT implementation and followed prospectively to measure differences and changes over time in caregiver wellbeing, parenting efficacy, satisfaction with healthcare systems, and toddler's social-communicative behaviors. We predict that implementation of the SRT model will be associated with higher rates of ASD screening by PCPs, earlier referral to EI programs, earlier initiation of ASD-specialized intervention, reduced time between ASD concerns and diagnosis, and improved caregiver and child outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screen-Refer-Treat Intervention | Experimental | Behavioral: Screen-Refer-Treat InterventionPCPs 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 |
| Control | No intervention | –No intervention received. |
Who may qualify
- Ages
- 16 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- -PCPs must work at a participating primary care practice.
- -EI providers must work at a participating early intervention agency.
- 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
- Toddlers must be between 16-20 months of age
Key exclusion criteria (3 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screen-Refer-Treat InterventionThis 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. | Behavioural | Screen-Refer-Treat Intervention |
Primary outcome
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
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
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
Caregiver report
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
Caregiver report
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
Caregiver self-report
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 35403446Tagavi DM, Dick CC, Attar SM, Ibanez LV, Stone WL. The implementation of the screening tool for autism in toddlers in Part C early intervention programs: An 18-month follow-up. Autism. 2023 Jan;27(1):173-187. doi: 10.1177/13623613221086329. Epub 2022 Apr 11.
- Derived from this study: PubMed 33901728Steinman 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.
- Derived from this study: PubMed 31174514Ibanez 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.
Related trials for Autism Spectrum Disorder
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy L Stone, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screen-Refer-Treat Intervention in people with Autism Spectrum Disorder, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409303, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.