Clinical trial NCT06651086: Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services
Official title: Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Executive Functioning
Keywords: Autism spectrum disorder
executive functioning
emotion regulation
mental health symptoms
Unified Protcol for Children
Unstuck and On Target
evidence based intervention
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, San Diego
name: University of Colorado, Denver
First posted: 2024-10-21
Enrollment: 672
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participating mental health programs from California and Colorado will be randomized to one of two conditions: Unstuck and On Target training and Unified Protocol for Children training. Therapists will be recruited from each participating program and enrolled as a dyad with target children. Autistic children will be enrolled at the beginning of therapist participation and before intervention training. Non-autistic children will be enrolled after intervention training and implementation or approximately 6 months after therapist enrollment. Participating therapists and child clients served in those programs will receive the same condition as their enrolled program.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 (e.g., 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 U.S. 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 (e.g., inflexibility, poor goal setting, poor planning) contribute to negative outcomes spanning multiple areas (e.g., 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 (e.g., 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.

Eligibility criteria: Inclusion Criteria:

Mental Health Programs:

* Publicly-funded
* Providing outpatient or school-based psychotherapy services to children
* Have at least 8 mental health providers on staff

Therapists:

* Employed as staff or trainee at a participating program
* Employed at the program for at least the next 12 months
* Providing psychotherapy services to children
* Has an eligible child on current caseload (see below)

Autistic Child/Caregiver Participants (enrolled in a dyad with a participating therapist):

* Child age 6-12 years
* Receiving services from an enrolled therapist
* Documented or suspected\* autism diagnosis

  * In the event of suspected autism diagnosis, the presence of elevated autism symptoms on the Social Responsiveness Scale-2nd Edition or the Autism Diagnostic Observation Scale-2nd Edition

Non-Autistic Child/Caregiver Participants (enrolled in a dyad with a participating therapist):

* Child age 6-12 years
* Receiving services from an enrolled provider
* No history of documented or suspected autism diagnosis

Primary outcomes:
measure: Changes in Child Mental Health Symptoms
timeFrame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
measure: Externalizing Behaviors
timeFrame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
measure: Evidence-based Intervention Fidelity
timeFrame: During 6-month EBI implementation
measure: Evidence-Based Intervention Training Engagement
timeFrame: 6-months post-EBI implementation
Secondary outcomes:
measure: Evidence-Based Intervention Reach
timeFrame: 6-months post-EBI implementation, 12-month follow-up after EBI implementation, 18-month follow-up after EBI implementation
measure: Psychotherapy Quality
timeFrame: 6-months post-EBI implementation
Other outcomes:
measure: Clinical Mediator: Changes in Executive Functioning, BRIEF-II
timeFrame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
measure: Clinical Mediator: Changes in Executive Functioning, EFCT
timeFrame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
measure: Clinical Mediator: Changes in Executive Functioning, DCCS
timeFrame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
measure: Clinical Mediator: Changes in Emotion Regulation
timeFrame: Pre-EBI implementation, 6-months post-EBI training, 12-month follow-up after EBI implementation
measure: Implementation Mediator: Changes in Intervention Perceptions of Fit, PCIS
timeFrame: Pre-EBI implementation, 6-months post-EBI implementation
measure: Implementation Mediator: Changes in Intervention Perceptions of Fit, IAM
timeFrame: Pre-EBI implementation, 6-months post-EBI implementation
measure: Implementation Mediator: Changes in Autism Self-Efficacy and Knowledge, Confidence
timeFrame: Pre-EBI implementation, 6-months post-EBI implementation
measure: Implementation Mediator: Changes in Autism Self-Efficacy and Knowledge, Knowledge
timeFrame: Pre-EBI implementation, 6-months post-EBI implementation
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
city: Aurora
country: United States
facility: University of Colorado - Anschutz
state: Colorado
Study officials:
References:
citation: Dickson KS, Galligan M, Holt T, Kenworthy L, Anthony L, Roesch S, Brookman-Frazee L. Randomized Feasibility Pilot of an Executive Functioning Intervention Adapted for Children's Mental Health Settings. J Autism Dev Disord. 2024 Apr 28. doi: 10.1007/s10803-024-06365-8. Online ahead of print.
citation: Dickson KS, Aarons GA, Anthony LG, Kenworthy L, Crandal BR, Williams K, Brookman-Frazee L. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol. Pilot Feasibility Stud. 2020 Apr 27;6:55. doi: 10.1186/s40814-020-00593-2. eCollection 2020.