- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04293627
Access to Tailored Autism Integrated Care Pilot Study (ATTAIN)
ADAPTING AND IMPLEMENTING AN INTEGRATED CARE MODEL FOR YOUTH WITH AUTISM SPECTRUM DISORDER AND PSYCHIATRIC COMORBIDITY
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This description is focused solely on the feasibility pilot test of ATTAIN in pediatric primary care.
Phase 3. Conduct an open trial feasibility pilot test of ATTAIN (directly informed by adaptations identified earlier in the larger study) in pediatric primary care.
Participants
Providers: A total of 45 pediatric care providers and staff will be recruited for enrollment from primary care practices in the region. This targeted sample size was chosen based on sample sizes used within completed pilot studies focused on service interventions in pediatric care. Each provider and healthcare staff member will be asked to use or support use of ATTAIN with up to 5 eligible patients over four months.
Families: Eligible pediatric patients must be: 1) English and/or Spanish-speaking, 2) between 4-16 years of age and 3) have a documented ASD diagnosis in the electronic health record. After four months of ATTAIN use by their child's primary care provider, caregivers will be contacted by the research team to be invited to complete an online survey about their child's healthcare experiences over the past four months.
Procedure Leadership at each primary care organization will be approached about their primary care practices participating in the pilot study. Primary care practices within each organization will be purposively selected for targeted recruitment of providers for ATTAIN implementation based on volume of patients with ASD. Members of the research team will request an invitation to present at regularly scheduled staff meetings to recruit primary care providers. Interested providers will be asked to complete a study interest form and indicate preferred times to attend a group meeting to review study participation details, the Study Information Sheet, and receive training in using the ATTAIN model. For some clinics, leadership may prefer that the recruitment and training be conducted during the same meeting for the purpose of reducing staff burden. At these meetings, the research team will provide a meal and refreshments. Subsequently, trained providers will be asked to use ATTAIN with up to 5 eligible patients during any outpatient appointment (e.g., annual check-ups, drop-in appointments) to maximize early detection of mental health problems and opportunity to link to mental health services. Throughout the 4 months, we may ask providers and supporting staff to elaborate on their experiences using ATTAIN via e-mail or phone-call to understand challenges to implementation, recommendations for improving implementation or adaptations in implementing the ATTAIN model in their clinic. Time to complete these brief reflections will take no more than 5-10 minutes each. Quantitative data of ATTAIN use will be extracted from patient charts and de-identified data will be sent to the research team during the four month study period and at the end of 4 months. After 4 months of ATTAIN delivery, participating providers and caregivers of youth with ASD with whom providers used ATTAIN will be asked to complete a brief online survey regarding their experiences using ATTAIN. Providers and staff will be asked to attend a meeting, where food and light refreshments will be provided, to complete the survey. In addition, providers and staff will be invited to participate in a post-study interview that will be offered to be completed by phone or in-person. Caregivers will receive $20 for survey completion. The ATTAIN model was developed to be embedded within routine primary care settings and workflow so there are minimal risks to primary care providers, caregivers or children associated with participation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
La Jolla, California, United States, 92093
- University of California, San Diego
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Providers: A total of 45 pediatric care providers and staff will be recruited for enrollment from primary care practices in the region. This targeted sample size was chosen based on sample sizes used within completed pilot studies focused on service interventions in pediatric care. Each provider and healthcare staff member will be asked to use or support use of ATTAIN with up to 5 eligible patients over four months.
Families: Eligible pediatric patients must be: 1) English and/or Spanish-speaking, 2) between 4-16 years of age and 3) have a documented ASD diagnosis in the electronic health record. After four months of ATTAIN use by their child's primary care provider, caregivers will be contacted by the research team to be invited to complete an online survey about their child's healthcare experiences over the past four months.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and acceptability of ATTAIN
Time Frame: Post-pilot (4 months of ATTAIN delivery)
|
The Perceived Characteristics of Intervention Scale (PCIS) will be used to examine providers' and staff's perspectives regarding feasibility and acceptability of ATTAIN.
The PCIS is a 20-item scale that assesses attitudes towards a specific intervention including relative advantage, compatibility, and complexity.
Participants are asked to rate the extent to which they agree with each item on a 5-point Likert scale.
Example items include, "The ATTAIN model is clear and understandable" and "Using the ATTAIN model fits well with the way I like to work."
|
Post-pilot (4 months of ATTAIN delivery)
|
Acceptability of Intervention Measure
Time Frame: Post-pilot (4 months of ATTAIN delivery)
|
A 4-item measure to assess the extent to which providers/staff believe ATTAIN is acceptable.
|
Post-pilot (4 months of ATTAIN delivery)
|
Feasibility of Intervention Measure
Time Frame: Post-pilot (4 months of ATTAIN delivery)
|
A 4-item measure to assess the extent to which providers/staff believe ATTAIN is feasible.
|
Post-pilot (4 months of ATTAIN delivery)
|
ASD + Mental Health Comfort and Knowledge Questionnaire
Time Frame: Post-pilot (4 months of ATTAIN delivery)
|
A questionnaire adapted from autism implementation studies (Brookman-Frazee et al., 2019; Stadnick et al., 2020) assessing provider perceptions of comfort and knowledge about serving children with ASD.
|
Post-pilot (4 months of ATTAIN delivery)
|
Measure of Innovation-Specific Implementation Intentions (MISII)
Time Frame: Post-pilot (4 months of ATTAIN delivery)
|
A 3-item measure assessing provider intentions to use a specific innovation (ATTAIN).
|
Post-pilot (4 months of ATTAIN delivery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ATTAIN Uptake
Time Frame: Post-pilot (4 months of ATTAIN delivery)
|
ATTAIN uptake will be measured using extracted data from the electronic health record system or provider-reported data about the number of patients with whom they used ATTAIN.
Specifically, uptake will be defined as the proportion of ATTAIN-eligible patients (i.e., children with a documented ASD diagnosis) to the number children with whom providers used ATTAIN.
|
Post-pilot (4 months of ATTAIN delivery)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nicole A Stadnick, PhD, MPH, Assistant Professor
Publications and helpful links
General Publications
- Stadnick NA, Brookman-Frazee L, Mandell DS, Kuelbs CL, Coleman KJ, Sahms T, Aarons GA. A mixed methods study to adapt and implement integrated mental healthcare for children with autism spectrum disorder. Pilot Feasibility Stud. 2019 Mar 28;5:51. doi: 10.1186/s40814-019-0434-5. eCollection 2019.
- Broder-Fingert S, Stadnick NA, Hickey E, Goupil J, Diaz Lindhart Y, Feinberg E. Defining the core components of Family Navigation for autism spectrum disorder. Autism. 2020 Feb;24(2):526-530. doi: 10.1177/1362361319864079. Epub 2019 Jul 16.
- Stadnick NA, Martinez K, Aarons GA, Lee DA, Van Cleave J, Brookman-Frazee L. Pediatric Primary Care Perspectives on Integrated Mental Health Care for Autism. Acad Pediatr. 2020 Nov - Dec;20(8):1140-1147. doi: 10.1016/j.acap.2020.03.006. Epub 2020 Mar 20.
- Stadnick NA, Lau AS, Dickson KS, Pesanti K, Innes-Gomberg D, Brookman-Frazee L. Service use by youth with autism within a system-driven implementation of evidence-based practices in children's mental health services. Autism. 2020 Nov;24(8):2094-2103. doi: 10.1177/1362361320934230. Epub 2020 Jul 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UC San Diego
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Autism Spectrum Disorder
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hoffmann-La RocheActive, not recruitingAutism Spectrum Disorder (ASD)United States, Canada, Italy, Spain
-
Axial Therapeutics, Inc.Active, not recruitingAutism Spectrum Disorder (ASD)United States, Australia, New Zealand
-
Technion, Israel Institute of TechnologyCompleted
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism | Autism Spectrum Disorder (ASD)United States
-
Corporacion Parc TauliUnknown
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyTerminatedAutism Spectrum Disorder (ASD)Spain, United States, Hungary, Poland, Australia, United Kingdom, Brazil, Czechia, France, Italy, Portugal, Slovakia
-
Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
National Taiwan University HospitalCompletedAutism Spectrum Disorder High-FunctioningTaiwan
Clinical Trials on ATTAIN
-
Medtronic Cardiac Rhythm and Heart FailureCompletedHeart FailureUnited States, France, Poland, Taiwan, Malaysia, Romania, China, Puerto Rico, Thailand, India, Canada, Pakistan, Hong Kong, Germany, Malta, Singapore
-
University of California, San DiegoNational Institute of Mental Health (NIMH); Kaiser PermanenteEnrolling by invitationAutism Spectrum Disorder | Mental Health | Implementation Science | Behavioral HealthUnited States
-
University of Sao PauloDuke UniversityUnknownCardiovascular Disease | Ventricular Dysfunction | Atrioventricular Block | Arrhythmias | BradyarrhythmiasBrazil
-
Medtronic Cardiac Rhythm and Heart FailureCompletedHeart FailureUnited States, Hong Kong, Netherlands, Germany, Sweden, Canada, Italy, Malaysia, Norway, Spain
-
Medtronic Cardiac Rhythm and Heart FailureCompletedHeart FailureUnited States, Canada, France, Italy, United Kingdom, Belgium, Spain, Germany, Malaysia, Serbia, South Africa, Saudi Arabia, Finland, Greece, Australia, Netherlands, Chile, Hungary, Austria, Romania, Switzerland, Slovakia, Norway, Israel and more