Autism Spectrum DisorderNCT06111092
Testing Design Thinking Methodology to Engage Hispanic and Latino Families of Autistic Children in Research.
A study testing Design Thinking and Focus Groups in people with Autism Spectrum Disorder and Patient Engagement, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The goal of this study is to compare two methods of engagement in research that include autistic individuals, Hispanic and Latino parents of autistic children, occupational therapy clinicians, teachers, and to use the information collected in the sessions to culturally adapt the occupational therapy Ayres Sensory… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Patient Engagement
- What is being tested?
- Design Thinking and Focus Groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Autistic person:
- confirmed diagnosis of autism spectrum disorder
- Hispanic/Latino
- received therapeutic services as a child; and
- willing and able (with i.e., language and cognitive skills) to participate in the design thinking or focus group session designed to learn about the facilitator and barriers to receipt of therapeutic services.
- Parent/caregiver:
- Hispanic/Latino caregiver of an autistic child who receives or received therapeutic services such as occupational, physical, speech and language therapy
- willing to participate in the design thinking or focus group session designed to learn about the facilitator and barriers to receipt of therapeutic services.
Who cannot join
- Do not meet age for autistic individual or diagnostic criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-5084
About this study
The goal of this study is to compare two methods of engagement in research that include autistic individuals, Hispanic and Latino parents of autistic children, occupational therapy clinicians, teachers, and to use the information collected in the sessions to culturally adapt the occupational therapy Ayres Sensory Integration intervention to improve participation and health outcomes.
The main questions it aims to answer are:
Read more
Does the Design Thinking process result in higher stakeholder engagement and satisfaction in the research process in comparison to Focus Groups? Secondary question: Do cultural adaptations using DT data yield higher acceptability and implementation feasibility scores than FG methods?
Participants will:
- Be randomized into two groups of engagement (focus groups and design thinking)
- Be blinded (clinicians, selected caregivers, autistic persons, and cultural experts) and will rate the culturally adapted manualized protocol and evaluate the acceptability, feasibility, and cultural appropriateness of each protocol based on DT data, higher than the protocol based on FG data.
Read the detailed description
Racial and ethnic minorities with autistic children experience delays in access to therapy services that can result in poorer outcomes, decreased quality of life, and increased parental and financial stress. Many autism interventions were developed and tested with only White participants, assuming they could be transferable to minority populations. However, research has found that this is not the case and that interventions that are not adapted to an individual's culture and ethnicity do not work as well and are not used as frequently. In this project, we compare two methods of stakeholder engagement, Design Thinking (DT) and Focus Groups (FG), to determine which is better at getting input on the facilitators and barriers to access therapy for autistic children. We focus on Hispanics and Latinos as this is the largest minority group in the US, with one of the fastest-growing groups of autistic children. Our long-term objective is to improve the functional skills and health of Hispanic/Latino autistic children and their families by improving access to an occupational therapy intervention designed to improve daily living skills, socialization, and quality of life. Occupational therapy using Ayres Sensory Integration (OT/ASI) is the only evidence-based intervention that addresses the sensory symptoms in autism. We will use input from these engagement sessions to adapt two versions of the OT/ASI manual: one using DT data and the other using FG data. Outcomes are evaluated following each step. Following the completion of this project, the planned outputs of the study are data on the most effective minority stakeholder engagement method and a culturally adapted OT/ASI manual for Hispanic and Latino autistic children for clinicians and researchers. This information can support future researchers who are engaging Hispanic/Latino individuals or other minority groups in research.
Methods: A randomized mixed methods design is used to evaluate stakeholder engagement methods. Phase one will compare two stakeholder engagement methods (Design Thinking -DT, and Focus Group - FG) and evaluate stakeholder engagement based on the PCORI areas of stakeholder engagement which are operationalized in the Stakeholder-Centric Engagement Evaluation and qualitative data. Phase two utilizes data from phase one to culturally adapt the intervention (two separate intervention protocols will be adapted - one based on FG data and another based on DT data as described below), and obtain stakeholder input on acceptability and feasibility for the Hispanic/Latino autistic population. This provides a second way to measure the effectiveness of each stakeholder engagement method as we will have data to indicate which method (DT or FG) resulted in the highest-rated protocol. The data provided by this study will be used as a basis for a later comparative effectiveness study that will study the culturally adapted protocol's outcomes.
All sessions will be held in Spanish and/or English based on the groups' preferences. Since our intent is to hear the voices of Hispanic/Latino stakeholders, it seems valuable to hold focus groups in Spanish when the participants are Spanish as first language speakers (hereafter referred to as Spanish-first) with audio recordings and later transcription into English for analysis. To accommodate those who prefer English, we will make every effort to group these participants together. When, and if, the Spanish-first groups include participants who prefer English, we will have a Spanish to English translator available. In other words, we will be respectful of each participant's language to optimize their comfort in the engagement sessions.
This project addresses an urgent need to engage stakeholders as part of the research process from conceptualization to dissemination and the need for culturally sensitive evidence-based interventions for Hispanic/Latino autistic children. This project is being developed by a skilled and experienced team of investigators.
- Conditions
- Autism Spectrum Disorder, Patient Engagement
- Being tested
- Design Thinking, Focus Groups
- Keywords
- Autism, Patient engagement
- Medical subject headings
- Autism Spectrum Disorder, Patient Participation, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Design ThinkingOther
Participants attend the DT session through all the stages that include emphasize, define, ideate, prototype and test.
Focus GroupsOther
Participants attend the FG that includes the introduction. discussion, and reflection.
| Study group | Role | What they receive |
|---|---|---|
| Design Thinking Group | Other | A group of randomized participants (autistic adults, parents/caregivers, OT practitioners, teachers, and cultural experts) will participate in the Design Thinking (DT) process. Receives: Other: Design Thinking |
| Focus Group | Other | A group of randomized participants (autistic adults, parents/caregivers, OT practitioners, teachers, and cultural experts) will participate in the Focus Group (FG) process. Receives: Other: Focus Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stakeholder-Centric Engagement Evaluation (S-CEE) (Martinez et al., 2021)
The Stakeholder-Centric Engagement Evaluation (S-CEE) is a measure used to assess the frequency and perceived quality of stakeholder engagement across 10 engagement domains, including: collaboration, communication, inclusion, transparency, learning, organizational structure, dissemination, and responsiveness to input. The measure evaluates two dimensions of engagement: frequency ("How Often") and quality ("How Well"). Each item is rated using a 5-point Likert scale. For "How Often," response options range from 1 ("Never") to 5 ("Always"). For "How Well," response options range from 1 ("Poor") to 5 ("Excellent"). Higher scores indicate greater frequency and higher perceived quality of stakeholder engagement. The S-CEE was administered to all participants immediately following the one-time engagement session to capture their perceptions of engagement.
Measured: Immediately following the one time engagement session
Secondary outcomes (1)
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017)
The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) are validated implementation outcome measures used to assess acceptability, appropriateness, and feasibility of the culturally adapted intervention based on the discussions in the focus groups and design thinking engagement sessions to improve access, use of therapy services, and strategies to adapt an evidence-based therapy intervention. AIM includes 5 items assessing the perceived acceptability of the intervention, IAM includes 4 items assessing the perceived appropriateness or fit of the intervention, and FIM includes 4 items assessing the perceived feasibility of implementing the intervention. Each item is rated using a 5-point Likert scale ranging from 1 ("Completely disagree") to 5 ("Completely agree"). Higher scores indicate greater perceived acceptability, appropriateness, and feasibility of the culturally adapted intervention.
Measured: Immediately following the cultural adaptation reviews.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Feb 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 Thomas Jefferson UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of this study is to improve the health and well-being of Hispanic/Latino autistic children by improving the utilization of the evidence-based autism intervention Ayres Sensory Integration and to improve stakeholder engagement in the research process for effective outcomes. Specific aims of this project are: 1. Compare DT and FG on measures of stakeholder engagement 2. Compare the acceptability and feasibility of the adapted intervention manuals (one based on FG and another on DT data). Design: A randomized mixed methods design is used to evaluate stakeholder engagement. Phase one will compare two stakeholder engagement methods (Design Thinking -DT, and Focus Group - FG) and evaluate stakeholder engagement. Phase two uses data from phase one to culturally adapt the intervention (two separate intervention protocols will be adapted, one from FG data and another from DT data) and obtain stakeholder input on acceptability and feasibility for the Hispanic/Latino population
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Roseann C Schaaf, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111092
- Sponsor's protocol ID
- 2022C2-28939
- Status last verified
- Aug 2026
- First submitted
- 26 Oct 2023
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publications in high-impact autism and occupational therapy journals and presentations at national and international autism research meetings.
Publications
Rios-Vega L, Rising K, Fields M, Freedman B, Toole N, Ramos J, Schaaf R. Engaging Diverse Stakeholders to Improve Therapy Access for Hispanic and Latino Autistic Individuals and Families. Am J Occup Ther. 2025 Mar 1;79(2):7902180150. doi: 10.5014/ajot.2025.050942.
PubMed 39970258
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Design Thinking Methodology to Engage Hispanic and Latino Families of Autistic Children in Research.
- ClinicalTrials.gov ID
- NCT06111092
- Acronym / sponsor ID
- 2022C2-28939
- Conditions
- Autism Spectrum Disorder, Patient Engagement
- Keywords
- Autism, Patient engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Posted 5 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare two methods of engagement in research that include autistic individuals, Hispanic and Latino parents of autistic children, occupational therapy clinicians, teachers, and to use the information collected in the sessions to culturally adapt the occupational therapy Ayres Sensory Integration intervention to improve participation and health outcomes.
The main questions it aims to answer are:
Does the Design Thinking process result in higher stakeholder engagement and satisfaction in the research process in comparison to Focus Groups? Secondary question: Do cultural adaptations using DT data yield higher acceptability and implementation feasibility scores than FG methods?
Participants will:
- Be randomized into two groups of engagement (focus groups and design thinking)
- Be blinded (clinicians, selected caregivers, autistic persons, and cultural experts) and will rate the culturally adapted manualized protocol and evaluate the acceptability, feasibility, and cultural appropriateness of each protocol based on DT data, higher than the protocol based on FG data.
Detailed description
Racial and ethnic minorities with autistic children experience delays in access to therapy services that can result in poorer outcomes, decreased quality of life, and increased parental and financial stress. Many autism interventions were developed and tested with only White participants, assuming they could be transferable to minority populations. However, research has found that this is not the case and that interventions that are not adapted to an individual's culture and ethnicity do not work as well and are not used as frequently. In this project, we compare two methods of stakeholder engagement, Design Thinking (DT) and Focus Groups (FG), to determine which is better at getting input on the facilitators and barriers to access therapy for autistic children. We focus on Hispanics and Latinos as this is the largest minority group in the US, with one of the fastest-growing groups of autistic children. Our long-term objective is to improve the functional skills and health of Hispanic/Latino autistic children and their families by improving access to an occupational therapy intervention designed to improve daily living skills, socialization, and quality of life. Occupational therapy using Ayres Sensory Integration (OT/ASI) is the only evidence-based intervention that addresses the sensory symptoms in autism. We will use input from these engagement sessions to adapt two versions of the OT/ASI manual: one using DT data and the other using FG data. Outcomes are evaluated following each step. Following the completion of this project, the planned outputs of the study are data on the most effective minority stakeholder engagement method and a culturally adapted OT/ASI manual for Hispanic and Latino autistic children for clinicians and researchers. This information can support future researchers who are engaging Hispanic/Latino individuals or other minority groups in research.
Methods: A randomized mixed methods design is used to evaluate stakeholder engagement methods. Phase one will compare two stakeholder engagement methods (Design Thinking -DT, and Focus Group - FG) and evaluate stakeholder engagement based on the PCORI areas of stakeholder engagement which are operationalized in the Stakeholder-Centric Engagement Evaluation and qualitative data. Phase two utilizes data from phase one to culturally adapt the intervention (two separate intervention protocols will be adapted - one based on FG data and another based on DT data as described below), and obtain stakeholder input on acceptability and feasibility for the Hispanic/Latino autistic population. This provides a second way to measure the effectiveness of each stakeholder engagement method as we will have data to indicate which method (DT or FG) resulted in the highest-rated protocol. The data provided by this study will be used as a basis for a later comparative effectiveness study that will study the culturally adapted protocol's outcomes.
All sessions will be held in Spanish and/or English based on the groups' preferences. Since our intent is to hear the voices of Hispanic/Latino stakeholders, it seems valuable to hold focus groups in Spanish when the participants are Spanish as first language speakers (hereafter referred to as Spanish-first) with audio recordings and later transcription into English for analysis. To accommodate those who prefer English, we will make every effort to group these participants together. When, and if, the Spanish-first groups include participants who prefer English, we will have a Spanish to English translator available. In other words, we will be respectful of each participant's language to optimize their comfort in the engagement sessions.
This project addresses an urgent need to engage stakeholders as part of the research process from conceptualization to dissemination and the need for culturally sensitive evidence-based interventions for Hispanic/Latino autistic children. This project is being developed by a skilled and experienced team of investigators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The aim of this study is to improve the health and well-being of Hispanic/Latino autistic children by improving the utilization of the evidence-based autism intervention Ayres Sensory Integration and to improve stakeholder engagement in the research process for effective outcomes. Specific aims of this project are: 1. Compare DT and FG on measures of stakeholder engagement 2. Compare the acceptability and feasibility of the adapted intervention manuals (one based on FG and another on DT data). Design: A randomized mixed methods design is used to evaluate stakeholder engagement. Phase one will compare two stakeholder engagement methods (Design Thinking -DT, and Focus Group - FG) and evaluate stakeholder engagement. Phase two uses data from phase one to culturally adapt the intervention (two separate intervention protocols will be adapted, one from FG data and another from DT data) and obtain stakeholder input on acceptability and feasibility for the Hispanic/Latino population
| Arm | Type | Receives |
|---|---|---|
| Design Thinking Group | Other | Other: Design ThinkingA group of randomized participants (autistic adults, parents/caregivers, OT practitioners, teachers, and cultural experts) will participate in the Design Thinking (DT) process. |
| Focus Group | Other | Other: Focus GroupsA group of randomized participants (autistic adults, parents/caregivers, OT practitioners, teachers, and cultural experts) will participate in the Focus Group (FG) process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Autistic person:
- Parent/caregiver:
Key exclusion criteria (1 listed)
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 |
|---|---|---|
| Design ThinkingParticipants attend the DT session through all the stages that include emphasize, define, ideate, prototype and test. | Other | Design Thinking Group |
| Focus GroupsParticipants attend the FG that includes the introduction. discussion, and reflection. | Other | Focus Group |
Primary outcome
Stakeholder-Centric Engagement Evaluation (S-CEE) (Martinez et al., 2021)
Time frame: Immediately following the one time engagement session
The Stakeholder-Centric Engagement Evaluation (S-CEE) is a measure used to assess the frequency and perceived quality of stakeholder engagement across 10 engagement domains, including: collaboration, communication, inclusion, transparency, learning, organizational structure, dissemination, and responsiveness to input. The measure evaluates two dimensions of engagement: frequency ("How Often") and quality ("How Well"). Each item is rated using a 5-point Likert scale. For "How Often," response options range from 1 ("Never") to 5 ("Always"). For "How Well," response options range from 1 ("Poor") to 5 ("Excellent"). Higher scores indicate greater frequency and higher perceived quality of stakeholder engagement. The S-CEE was administered to all participants immediately following the one-time engagement session to capture their perceptions of engagement.
1 secondary outcome
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017)
Time frame: Immediately following the cultural adaptation reviews.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39970258Rios-Vega L, Rising K, Fields M, Freedman B, Toole N, Ramos J, Schaaf R. Engaging Diverse Stakeholders to Improve Therapy Access for Hispanic and Latino Autistic Individuals and Families. Am J Occup Ther. 2025 Mar 1;79(2):7902180150. doi: 10.5014/ajot.2025.050942.
- Individual participant dataSharing planned: Yes. Publications in high-impact autism and occupational therapy journals and presentations at national and international autism research meetings.
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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.
Roseann C Schaaf principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Design Thinking and Focus Groups in people with Autism Spectrum Disorder and Patient Engagement, run by Thomas Jefferson University 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 8 inclusion and 1 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 5 Nov 2026. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stakeholder-Centric Engagement Evaluation (S-CEE) (Martinez et al., 2021) (time frame: Immediately following the one time engagement session). 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 NCT06111092, which also lists 1 linked publication.
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 5 Nov 2026.