The Emotion Awareness and Skills Enhancement (EASE) Program Versus the Unified Protocol (UP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 470
- 试验地点
- 3
- 主要终点
- Provider Self-Efficacy Scale
研究概览
简要总结
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.
详细描述
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 12 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A rater blind to condition assignment will assign CGI ratings.
入排标准
- 年龄范围
- 10 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •professional diagnosis of ASD
- •a score in the clinical range on the EDI-Reactivity or EDI-Dysphoria scale based on caregiver report or self-report
- •The study is open to people with a range of communication abilities. Participants must be able to consent to the study themselves and answer questions about themselves.
- •Participants need to have a support person that could answer questions about them too. This could be a parent, caregiver, family member, partner or friend. Independent adults can opt out of this portion.
- •Participants must live in Alabama or Pennsylvania.
排除标准
- •- Higher level of care is needed (Imminent Suicide / Homicide Threat, acute psychosis, mania)
研究组 & 干预措施
The Emotion Awareness and Skills Enhancement
EASE is a 16-session mindfulness-based intervention (MBI). It emphasizes a small set of core concepts (i.e., mindfulness practices, distress tolerance, encouraging helpful thoughts, self-compassion) that are repeated with consistent language throughout. Emphasis is placed on increasing awareness of gradients of emotional arousal.
干预措施: The Emotion Awareness and Skills Enhancement Program (Behavioral)
The Unified Protocol
UP is a 12-21 session cognitive behavioral therapy (CBT) based treatment. In this study, there will be 16 sessions. UP is focused on identifying emotions and building new coping strategies. It is customizable to meet the needs of the individual.
干预措施: The Unified Protocol (Behavioral)
结局指标
主要结局
Provider Self-Efficacy Scale
时间窗: Baseline and Post trial (4 years)
It assesses both knowledge (of protocol) and confidence (in one's ability to implement as intended). It is a 0-10 scale, where 0 is not at all confident and 10 is extremely confident. Higher scores indicate higher confidence.
Emotion Dysregulation Inventory
时间窗: Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
The EDI does not have a single overall score. It is comprised of two scales: Reactivity and Dysphoria. Items are on a 0 to 4 scale, where 0 is Never happens and 4 is Almost always happens or causes a serious problem. There are clinical cutoffs for both scales.
Weiner's Acceptability, Appropriateness, & Feasibility of Intervention Scales
时间窗: Baseline and Post treatment of first client (after all 16 sessions, average 16-20 weeks)
Weiner's is a widely used 12-item battery of three scales assessing intervention acceptability, appropriateness, and feasibility with strong psychometric properties. There is a 1 to 5 scale, where 1 is Completely disagree and 5 is Completely agree. Higher scores indicate greater acceptability, appropriateness, and feasibility.
次要结局
- PROMIS Depression(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment)
- Child & Adolescent Mindfulness Measure(Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks))
- WHO Quality of Life-BREF-ID(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment)
- Buss-Perry Aggression Questionnaire(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment)
- Satisfaction with Life Scale(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks))
- Credibility and Expectancy Questionnaire(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks))
- Inventory of Statements about Self-Injury(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment)
- Working Alliance Inventory(Midpoint (after completing 8 sessions, average 8 weeks), After completing 15 sessions (average 15-19 weeks))
- Clinical Global Impressions(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks))
- PROMIS Anxiety(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment)
- Emotion Regulation Questionnaire for Children and Adolescents(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment)
- Self-Compassion Scale-Youth Version(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment)
- AASPIRE Patient Health Questionnaire-9(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment)
- AASPIRE Flourishing Scale(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment)
- AASPIRE Burnout Scale Short Form(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment)
- Relationships, Employment, Autonomy, and Life Satisfaction(Baseline, Post treatment (after all 16 sessions, average 16-20 weeks))
- Vanderbilt Therapeutic Alliance Scales Revised, Short Form(2 randomized timepoints over up to 20 Weeks)
- Child Involvement Rating Scale(2 randomized timepoints over up to 20 Weeks)
研究者
Carla Mazefsky
Professor of Psychiatry, Psychology, and Clinical and Translational Science
University of Pittsburgh