Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 672
- 试验地点
- 3
- 主要终点
- Changes in Child Mental Health Symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Observational Coders Direct Assessor
入排标准
- 年龄范围
- 6 Years 至 99 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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 therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder.
干预措施: Unstuck and On Target (Behavioral)
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 effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability).
干预措施: Unified Protocol for Children (Behavioral)
结局指标
主要结局
Changes in Child Mental Health Symptoms
时间窗: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
Changes in mental health symptoms will be measured by the Child Behavior Checklist (CBCL), a 113-item rating scale measuring a range of mental health symptoms.
Externalizing Behaviors
时间窗: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
Primary outcome measures include externalizing behaviors. The Eyberg Child Behavior Inventory (ECBI), a 36-item widely used rating scale, will measure these behaviors.
Evidence-based Intervention Fidelity
时间窗: During 6-month EBI implementation
A trained observer masked to evidence-based intervention (EBI) condition and time will assess EBI delivery during recorded sessions of participating therapist-client dyads. Unique fidelity forms with items corresponding to each EBI (Unstuck and On Target and Unified Protocol for Children) will be used. Items rate adherence (i.e., the degree to which key components are delivered as intended) and competence (responsiveness, engagement, skill). Items are rated on a 1-5 scale, with higher scores indicating better fidelity. Measures have internal consistencies and are shown to be sensitive to treatment effects.
Evidence-Based Intervention Training Engagement
时间窗: 6-months post-EBI implementation
Therapist evidence-based intervention (EBI) training engagement will be operationalized as adherence to training requirements, including participation in training/consultation (as rated by trainers) and training-related submissions (forms, materials).
次要结局
- Evidence-Based Intervention Reach(6-months post-EBI implementation, 12-month follow-up after EBI implementation, 18-month follow-up after EBI implementation)
- Psychotherapy Quality(6-months post-EBI implementation)
研究者
Kelsey Dickson
Associate Professor
San Diego State University
