Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651086
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Childrens Mental Health Services
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Childrens Mental Health Services
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target UOT adapted for community mental health settings Study aims are to test the clinical and implementation effectiveness of training mental health therapists in Unstuck and On Target an executive functioning intervention relative to Unified Protocol for Children a transdiagnostic intervention for emotional disorders This includes examining the implementation of Unstuck and associated outcomes eg effective delivery expanded use of Unstuck beyond autism the feasibility of Unstuck and impact on changes in child executive functioning and behaviors
Detailed Description:
Autism is a highly prevalent neurodevelopmental condition affecting 1 in 36 youth The annual cost in the US of autism was 223 billion in 2020 and is estimated to rise to 589 billion by 2030 Outcomes are poor and care disparities and high rates of unmet service needs are common Mental health services play a key role in caring for autistic youth There have been efforts to develop evidence-based interventions EBIs with the potential to lessen the public health burden of autism Yet research indicates limited community EBI penetration Several work gaps remain including a focus on EBIs designed for community implementation and those addressing multilevel barriers impeding EBI use There is an urgent need to focus on EBIs that improve mental health services for autism and optimize outcomes for this priority complex population Executive functioning EF is a potent mechanism underlying autism and commonly co-occurring mental health conditions EF impairments eg inflexibility poor goal setting poor planning contribute to negative outcomes spanning multiple areas eg academic vocational health Our work underscores the impact of EF deficits on mental health services including its transdiagnostic impact on the majority of children served in this setting and its role as a barrier to psychotherapy engagement and progress EF is responsive to treatment and mental health therapists cite a significant need and motivation for EF treatments making EF EBIs highly relevant for community mental health settings However EF EBIs have not been widely used and tested in such settings Autism EBIs or those developed or adapted for autistic youth have the potential to enhance mental health services in addition to improving service quality for the populations targeted eg autism This is due to the specific components and strategies incorporated into the EBI to enhance its impact and fit We propose a Hybrid Type 2 randomized trial examining the effectiveness and implementation of an autism EF EBI Unstuck and On Target in community mental health settings Unstuck and On Target is a cognitive-behavioral EF intervention effective for autism
With NIMH funding K23MH115100 Unstuck and On Target were systematically adapted for and tested in mental health settings with a pilot test suggesting its preliminary effectiveness high fidelity and use beyond autism Findings have the potential to transform implementation and service quality for the high-priority population of autistic youth as well as youth generally Aim 1 Evaluate the effectiveness and implementation of an autism EBI Unstuck and On Target relative to a non-autism transdiagnostic intervention Unified Protocol for Children for autistic youth Aim 2 Evaluate mediators of EBI training effects to confirm engaged change mechanisms of clinical and implementation outcomes Aim 3 Explore the generalized effects of EBI training on reach and improved psychotherapy quality with non-autistic youth
With NIMH funding K23MH115100 Unstuck and On Target were systematically adapted for and tested in mental health settings with a pilot test suggesting its preliminary effectiveness high fidelity and use beyond autism Findings have the potential to transform implementation and service quality for the high-priority population of autistic youth as well as youth generally Aim 1 Evaluate the effectiveness and implementation of an autism EBI Unstuck and On Target relative to a non-autism transdiagnostic intervention Unified Protocol for Children for autistic youth Aim 2 Evaluate mediators of EBI training effects to confirm engaged change mechanisms of clinical and implementation outcomes Aim 3 Explore the generalized effects of EBI training on reach and improved psychotherapy quality with non-autistic youth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None