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.