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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06111092
Other study ID # 2022C2-28939
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date November 30, 2026

Study information

Verified date October 2023
Source Thomas Jefferson University
Contact Roseann C Schaaf, PhD
Phone 6102912179
Email roseann.schaaf@jefferson.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to compare the level of engagement in the Hispanic and Latino parents of autistic children and culturally adapt the protocol of Ayres Sensory Integration 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 adaption using DT data yield higher scores of acceptability and implementation feasibility in comparison to 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 acceptability, feasibility, and cultural appropriateness of the protocol based on DT data higher than the protocol based on FG data.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 186
Est. completion date November 30, 2026
Est. primary completion date July 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. - Exclusion Criteria: - Do not meet age for autistic individual or diagnostic criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Design Thinking
Participants attend the DT session through all the stages that include emphasize, define, ideate, prototype and test.
Focus Groups
Participants attend the FG that includes the introduction. discussion, and reflection.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Thomas Jefferson University Patient-Centered Outcomes Research Institute

Outcome

Type Measure Description Time frame Safety issue
Primary Stakeholder-Centric Engagement Evaluation The instrument evaluates stakeholder engagement via the PCORI engagement principles. DT and FG participants use this instrument to rate engagement in throughout the research process using a Likert scale with 1= never and 5 = always. up to 14 weeks
Secondary Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017) These are outcome measures that evaluate implementation success via the extent to which stakeholders believe the intervention is acceptable, appropriate, and feasible. Each measure uses a Likert response scale where 1 = completely disagree and 5 = completely agree. up to 14 weeks
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