Autism Spectrum DisorderATTAINNCT04293627
Access to Tailored Autism Integrated Care Pilot Study
An observational study of Autism Spectrum Disorder and Mental Health Issue, run by University of California, San Diego at 1 site in United States.
Trial summary
Children with autism spectrum disorder (ASD) represent a rapidly growing, high-priority clinical population highlighted by the NIMH and Interagency Autism Coordinating Committee due, in part, because they have multiple service needs including access to effective mental health treatment given high rates of psychiatric… Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Mental Health Issue
- What is being tested?
- ATTAIN
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 10 Mar 2022
- Phase
- Observational
- 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 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Providers and families will be recruited from pre-identified pediatric primary care clinics in Southern California serving children with autism spectrum disorder.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: ADAPTING AND IMPLEMENTING AN INTEGRATED CARE MODEL FOR YOUTH WITH AUTISM SPECTRUM DISORDER AND PSYCHIATRIC COMORBIDITY
Children with autism spectrum disorder (ASD) represent a rapidly growing, high-priority clinical population highlighted by the NIMH and Interagency Autism Coordinating Committee due, in part, because they have multiple service needs including access to effective mental health treatment given high rates of psychiatric comorbidities. Pediatric primary care is a critical and ongoing point of health care access for children with ASD and thus represents an ideal setting for identification of mental health service needs and appropriate linkage to care. The proposed study will use implementation science theory and methods and a research-community partnership approach to: 1) identify targets to improve mental health screening and linkage to mental health services in primary care for children with ASD, 2) adapt integrated care procedures into "Access To Tailored Autism INtegrated Care," ATTAIN, to facilitate identification of mental health problems and linkage to evidence-based care for youth with ASD, and 3) conduct an open trial feasibility pilot test of ATTAIN in pediatric primary care.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Mental Health Issue
- Being tested
- ATTAIN
- Keywords
- pediatric primary care, implementation science, co-occurring mental health conditions, community academic partnership
- 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.
ATTAINBehavioural
ATTAIN is an 8-step model to identify co-occurring mental health conditions and facilitate linkage to mental health services for youth with an existing autism spectrum disorder diagnosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of ATTAIN
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."
Measured: Post-pilot (4 months of ATTAIN delivery)
Acceptability of Intervention Measure
A 4-item measure to assess the extent to which providers/staff believe ATTAIN is acceptable.
Measured: Post-pilot (4 months of ATTAIN delivery)
Feasibility of Intervention Measure
A 4-item measure to assess the extent to which providers/staff believe ATTAIN is feasible.
Measured: Post-pilot (4 months of ATTAIN delivery)
ASD + Mental Health Comfort and Knowledge Questionnaire
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.
Measured: Post-pilot (4 months of ATTAIN delivery)
Measure of Innovation-Specific Implementation Intentions (MISII)
A 3-item measure assessing provider intentions to use a specific innovation (ATTAIN).
Measured: Post-pilot (4 months of ATTAIN delivery)
Secondary outcomes (1)
ATTAIN Uptake
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.
Measured: Post-pilot (4 months of ATTAIN delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start13 Nov 2019
- Primary completion31 Oct 2021
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, San Ysidro Health Center, Rady Children's Hospital, San Diego
- Responsible party
- Principal investigator, Nicole Stadnick, University of California, San Diego
- Investigators
- Nicole A Stadnick, PhD, MPH, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293627
- Sponsor's protocol ID
- UC San Diego
- Acronym
- ATTAIN
- Status last verified
- Mar 2022
- First submitted
- 27 Feb 2020
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers may contact the PI to request de-identified data in aggregate form, as appropriate.
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.
PubMed 30976456Broder-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.
PubMed 31311287Stadnick 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.
PubMed 32205263Stadnick 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.
PubMed 32686469
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAPTING AND IMPLEMENTING AN INTEGRATED CARE MODEL FOR YOUTH WITH AUTISM SPECTRUM DISORDER AND PSYCHIATRIC COMORBIDITY
- ClinicalTrials.gov ID
- NCT04293627
- Acronym / sponsor ID
- ATTAIN / UC San Diego
- Conditions
- Autism Spectrum Disorder, Mental Health Issue
- Keywords
- pediatric primary care, implementation science, co-occurring mental health conditions, community academic partnership
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Kaiser Permanente, San Ysidro Health Center, Rady Children's Hospital, San Diego
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 3 Mar 2020 (actual)
- 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.
Children with autism spectrum disorder (ASD) represent a rapidly growing, high-priority clinical population highlighted by the NIMH and Interagency Autism Coordinating Committee due, in part, because they have multiple service needs including access to effective mental health treatment given high rates of psychiatric comorbidities. Pediatric primary care is a critical and ongoing point of health care access for children with ASD and thus represents an ideal setting for identification of mental health service needs and appropriate linkage to care. The proposed study will use implementation science theory and methods and a research-community partnership approach to: 1) identify targets to improve mental health screening and linkage to mental health services in primary care for children with ASD, 2) adapt integrated care procedures into "Access To Tailored Autism INtegrated Care," ATTAIN, to facilitate identification of mental health problems and linkage to evidence-based care for youth with ASD, and 3) conduct an open trial feasibility pilot test of ATTAIN in pediatric primary care.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Providers and families will be recruited from pre-identified pediatric primary care clinics in Southern California serving children with autism spectrum disorder.
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 |
|---|---|---|
| ATTAINATTAIN is an 8-step model to identify co-occurring mental health conditions and facilitate linkage to mental health services for youth with an existing autism spectrum disorder diagnosis. | Behavioural | – |
Primary outcome
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."
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.
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.
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.
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).
1 secondary outcome
ATTAIN Uptake
Time frame: Post-pilot (4 months of ATTAIN delivery)
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 28 Mar 2022.
- Background: PubMed 30976456Stadnick 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.
- Background: PubMed 31311287Broder-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.
- Background: PubMed 32205263Stadnick 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.
- Background: PubMed 32686469Stadnick 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.
- Individual participant dataSharing planned: No. Researchers may contact the PI to request de-identified data in aggregate form, as appropriate.
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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.
Nicole A Stadnick, PhD, MPH principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Mental Health Issue, run by University of California, San Diego 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?
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 28 Mar 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?
Feasibility and acceptability of ATTAIN (time frame: Post-pilot (4 months of ATTAIN delivery)). The study lists 5 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 NCT04293627, which also lists 4 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 28 Mar 2022.