Testing Design Thinking Methodology to Engage Hispanic and Latino Families of Autistic Children in Research.

NCT06111092 | Not Yet Recruiting

• 1 other identifier: 2022C2-28939
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Autism Spectrum Disorder; Patient Engagement

Keywords

Autism; Patient engagement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017)

  up to 14 weeks

Study Arms (2)

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.

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.

Other: Focus Groups

Interventions

Design Thinking OTHER

Participants attend the DT session through all the stages that include emphasize, define, ideate, prototype and test.

Design Thinking Group

Focus Groups OTHER

Participants attend the FG that includes the introduction. discussion, and reflection.

Focus Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Do not meet age for autistic individual or diagnostic criteria

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Patient-Centered Outcomes Research Institute: collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder; Patient Participation; Autistic Disorder

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Roseann C Schaaf

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roseann C Schaaf, PhD

CONTACT

6102912179; roseann.schaaf@jefferson.edu

Lady J Rios- Vega, OTD

CONTACT

8568894683; lady.rios-vega@jeferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * data analysts are blind to the study arm so that their interpretation and analysis of the data is unbiased. * in Aim 2, the two adapted intervention protocols will be created, each based on data from either the design thinking or focus group sessions. These protocols will then be rated for acceptability, feasibility and cultural appropriateness using standardized measures and stakeholder input. This rating will be performed by individuals who are blinded to study arm that was used for adaptation of each protocol.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available following completion of the study and publication of findings.
• Access Criteria: Upon written request (reviewed by the principal investigator) information will be shared.