Viewing Study NCT06158581



Ignite Creation Date: 2024-05-06 @ 7:50 PM
Last Modification Date: 2024-10-26 @ 3:15 PM
Study NCT ID: NCT06158581
Status: RECRUITING
Last Update Posted: 2024-05-29
First Post: 2023-11-27

Brief Title: Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults
Sponsor: University of Pittsburgh
Organization: University of Pittsburgh

Study Overview

Official Title: The Emotion Awareness and Skills Enhancement EASE Program Versus the Unified Protocol UP
Status: RECRUITING
Status Verified Date: 2024-05
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: Too few clinicians are able and willing to help autistic patients A recent review identified challenges to mental health service delivery in autism including a lack of interventions designed for community implementation and limited workforce capacity It has been argued that improving impairment in emotion regulation has the potential to improve a range of mental health difficulties in autistic people In this clinical trial the investigators are comparing two evidence-based interventions for emotion regulation to determine if one created specifically for autistic people is clinically superior The interventions will be implemented in the community through partnering agencies
Detailed Description: This study will compare the effectiveness of two transdiagnostic interventions for autistic adolescents and young adults - an intervention in widespread use among non-autistic populations The Unified Protocol UP versus an autism-specific intervention The Emotion Awareness and Skills Enhancement Program EASE The UP and EASE are ideal comparators because they are structurally equivalent and transdiagnostic - both shown to improve mental health outcomes that stakeholders identify as important such as depression irritability and anxiety The investigators will partner with 10 different community clinics in Pennsylvania and Alabama to recruit participants and facilitate the interventions Each clinic will be randomized to use either UP or EASE The investigators will look at effectiveness of the treatments as well as the feasibility benefits and harms

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
Secondary IDs
Secondary ID Type Domain Link
IDD-2022C1-26418 OTHER_GRANT PCORI None