Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Unstuck and On Target
  Unstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the t
• Поведенческое Unified Protocol for Children
  Unified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiven

Первичные конечные точки

• Changes in Child Mental Health Symptoms [Срок оценки: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation]
• Externalizing Behaviors [Срок оценки: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation]
• Evidence-based Intervention Fidelity [Срок оценки: During 6-month EBI implementation]
• Evidence-Based Intervention Training Engagement [Срок оценки: 6-months post-EBI implementation]

Вторичные конечные точки (2)

• Evidence-Based Intervention Reach [Срок оценки: 6-months post-EBI implementation, 12-month follow-up after EBI implementation, 18-month follow-up after EBI implementation]
• Psychotherapy Quality [Срок оценки: 6-months post-EBI implementation]

Критерии участия

Критерии включения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• San Diego State University — San Diego
• University of Colorado - Anschutz — Aurora

Публикации

• 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. 2025 Jul;55(7):2407-2421. doi: 10.1007/s10803-024-06365-8. Epub 2024 Apr 28. PMID 38678517
• 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. PMID 32699642
• Dickson KS, Kennedy SM, Safer J, Brookman-Frazee L, Roesch S, Anthony LG. Study protocol for a hybrid type 2 effectiveness-implementation trial of two interventions for autistic and non-autistic youth in children's mental health settings: one tailored for neurodivergence and one universal. Implement Sci Commun. 2025 Nov 26;6(1):131. doi: 10.1186/s43058-025-00799-6. PMID 41299783

Идентификаторы

NCT: NCT06651086 · HS-2024-0105 · R01MH137179

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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