Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05695885
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-01-13
Brief Title:
STEPS Implementation Trial
Sponsor:
University of Alabama Tuscaloosa
Organization:
University of Alabama Tuscaloosa
Study Overview
Official Title:
Stepped Transition in Education Program for Emerging Adults With Autism Pilot Effectiveness Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will inform understanding of how to support emerging adults with autism spectrum disorder ASD The investigators will use a theoretically informed and research-based transition support program developed for people with ASD and test how effective it is when delivered by community agencies Results will provide information on the effectiveness of the program as well as on mechanisms of change and contextual factors that promote or impede implementation
Detailed Description:
The long-term goal of this research is to improve adult outcomes for people with autism spectrum disorder ASD Autistic adolescents and young adults tend to have worse outcomes with respect to employment education and quality of life than neurotypical peers These outcomes include under-enrollment into college unemployment and limited functional independence Research-informed transition planning that addresses core impairments in skills related to adult autonomy including self-knowledge self-determination and self-regulation may improve outcomes for this growing population In prior research investigators developed a stakeholder involved transition program STEPS and found it to be feasible acceptable and efficacious Data from a small randomized controlled trial RCT focusing on feasibility indicated that it was acceptable to participants and suggested STEPS was effective in improving readiness for transition to adulthood The team will now test the effectiveness of STEPS and engagement of target mechanisms in partnership with four community agencies This study is designed as a Hybrid Type 1 which focuses primarily on intervention effectiveness with a secondary focus on factors related to implementation Immediate post-treatment and longer-term six month follow-up clinical outcomes of adult functional outcomes and vocational engagement will be assessed The degree to which STEPS leads to change in the theoretical mediating mechanisms ie adult autonomy skills will be examined as well as a formal test of mediation ie the degree to which change in adult autonomy skills leads to change in adult functional outcomes Providers will provide qualitative information on implementation such as thoughts on STEPS cultural sensitivity and quantitative data on the appropriateness feasibility and acceptability of STEPS Providers sustained use of STEPS with clients in the six months after study enrollment has ended will also be tracked This research will produce findings that have the potential to shift clinical practice related to transition to adulthood for people with ASD In light of the fact that approximately 70000 people with ASD age into adulthood every year and the economic burden associated with ASD the potential public health impact of this research is considerable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None