Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06309160 |
Other study ID # |
R324A230008 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 1, 2023 |
Est. completion date |
July 2027 |
Study information
Verified date |
March 2024 |
Source |
Ball State University |
Contact |
Lisa A Ruble, PhD |
Phone |
765-285-5702 |
Email |
lisa.ruble[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Purpose: The purpose of this project is to develop and test the COMPASS [Collaborative Model
for Competence and Success] Across Settings (CAST) intervention to enhance the goal setting
and attainment skills of autistic youth. Despite federal education law mandating transition
services as part of the Individualized Education Program (IEP) for ensuring good outcomes for
students with disabilities, current educational practices have been unable to demonstrate
that autistic students experience positive postsecondary outcomes. There are existing,
evidence-based interventions aimed at supporting positive outcomes for these students.
However, these interventions have not systematically provided coaching support to the
caregivers, students, and employment specialists. To address these issues, CAST will
integrate three evidence-based interventions for supporting student transitions while
providing this critical coaching support. By doing so, CAST aims to align the priorities and
goals of interventions across home, school, and community settings to better support positive
postsecondary outcomes for autistic students.
Description:
Project Activities: The research team will use an iterative approach for integrating the
three interventions into CAST, obtaining feedback from focus groups and stakeholder members
along the way, and running a field trial after development. The research team will then
conduct a randomized controlled trial (RCT) of CAST to examine postsecondary outcomes at both
3 months and 1 year after high school. Social network analysis will be used to understand the
integration of services and a cost analysis will be conducted.
Products: This project will result in a fully developed intervention, CAST, for improving IEP
and postsecondary outcomes of autistic students. The project will also result in
peer-reviewed publications, information on the costs of CAST implementation, an updated
intervention manual with fidelity checklists, and other dissemination products aimed at
stakeholders.
STRUCTURED ABSTRACT
Setting: This project will take place in public high schools in Indiana.
Sample: Approximately 38 administrators, special education teachers, caregivers,
pre-employment transition specialists, and autistic youth will participate in focus groups
and interviews in the first year. The field test in year 2 will include five autistic youth
and their parents, five classroom special education teachers, and five employment transition
specialists. Approximately 140 participants (40 autistic youth and young adults, 40
caregivers, 40 special education teachers, and 20 pre-employment specialists who serve
autistic youth) will participate in the pilot RCT in year 3.
Intervention: CAST will integrate three evidence-based interventions- COMPASS, C-HOPE, and
COMPASS-T. COMPASS is the original intervention designed for preschool and elementary age
students. COMPASS-T is the adaptation of COMPASS for transition-aged youth. Lastly, C-HOPE is
based on COMPASS and is a parent-mediated intervention designed to decrease child problem
behavior, increase parent competency, and decrease parent stress. CAST will begin with an
initial joint session with the student, caregiver, special education teacher, and
pre-employment transition specialist that allows for discussion on the student's
postsecondary goals, preferences, frustrations, challenges, and strengths related to social
skills, adaptive/self-management, communication, problem behaviors, learning skills, and
sensory sensitivities and preferences. This discussion will pinpoint critical social,
communication, and work behavior/learning goals related to postsecondary goals and inform the
intervention plans that are generated for each goal. Following this initial consultation,
there will be four additional 1-hour sessions that incorporate evidence-based coaching,
provided by the investigators, including performance feedback monitoring and instructional
support. Each session is standardized and allows for assessment of student progress and
intervention modification/self-reflection on the implementation of the intervention plans.
Research Design and Methods: For the year 1 development activities, the research team will
conduct focus groups with administrators, special education teachers, parents, students, and
pre-employment transition specialists about how to integrate plans and services across
settings. The research team will then conduct a field test of CAST in year 2, making further
revisions. In year 3, they will use a mixed methods design using a small RCT and network
analysis, oversampling African American students and students from rural areas, to evaluate
CAST for improved postsecondary outcomes in employment, training, and education. The
secondary aims of the project are to obtain (a) information on how well CAST improves
integration and alignment of services across settings and thus student IEP and postsecondary
outcomes; (b) information on feasibility, usability, and fidelity; and (c) estimates of
costs.
Control Condition: Students in the control condition will receive services as usual.
Key Measures: The primary outcome data will be student goal attainment (GAS) of IEP goals and
postsecondary goals. IEP goal attainment is assessed using psychometric equivalence goal
attainment scaling (PET-GAS). Postsecondary outcomes will be assessed by parent report of
attainment in goals (such as enrolling in a training or college program and living
independently). Additional measures completed by all CAST participants (caregivers, students,
special education teachers, and pre-employment specialists) include assessment of transition
plan quality, organizational connectedness, and fidelity assessments.
Data Analytic Strategy: Focus groups and interviews will be recorded, transcribed, checked
for accuracy, and analyzed using a consensual coding technique that will be used to provide a
multi-dimensional picture for refining CAST. For the field test, the research team will use a
dependent sample t-test to examine whether there is a significant improvement in GAS scores
at the end of the year and whether there is a change in students' postsecondary outcomes from
end of high school to 3 months out from high school. For the RCT, the research team will use
a multilevel model on GAS scores at the end of year and postsecondary outcomes at both
post-school time points. Pearson correlations will be used to examine associations in student
outcomes and intervention fidelity measures with the CAST participants. Social network
analysis will be used to understand integration of services.
Cost Analysis: For the cost analysis, individual ingredients associated with CAST will be
identified through a discussion with participants, administrators, and other stakeholders.
The costs of each ingredient will then be determined through a review of official records,
where possible. Using these various sources, the total cost of implementation will be
calculated.