Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 4
- 主要终点
- The Clinical Global Impression Scale- Improvement (CGI-I)
研究概览
简要总结
This project will address impaired emotion regulation in adolescents with ASD (autism spectrum disorder). There are no evidence-based interventions to improve emotion regulation (ER) in this population, yet poor emotion regulation often leads to maladaptive behavior and substantially impedes capacity to learn and function across all life settings, and reduce their quality of life and that of their families. The primary objective of this study is to formally evaluate efficacy of EASE via a sufficiently powered, two-site randomized-controlled trial (RCT).
详细描述
The current study is to test a new intervention called Emotional Awareness and Skills Enhancement (EASE). This program was designed to address ASD-specific obstacles to effective emotion regulation, such as reduced awareness concerning others' intentions, a limited repertoire of behavioral responses, and inadequate language for understanding emotional experiences. This new program is based on an acceptance-based approach in which awareness of emotion is developed, emotions (whether negative or positive) are accepted, and behavior is regulated in the face of intense emotion. The goal is not to learn to avoid negative emotions, but rather to develop a collection of abilities which allow the individual to manage stress and act in ways that are more adaptive. The investigators expect to find that participants' emotion dysregulation will decrease and their adaptive function will increase following completion of the EASE program.
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)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 12-21 years, inclusive
- •A diagnosis of ASD (autism spectrum disorder), as defined by exceeding the ASD cutoff on the ADOS-2 (Autism Diagnostic Observation Scale) or ADI-R (Autism Diagnostic Interview-Revised) In. If the participant has completed the ADOS in a previous study within 3 years and signs a release of information to obtain it, they will not be required to complete another ADOS.
- •Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 [WASI-2] FSIQ >=75).
- •Fluent in the English language
- •Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments.
排除标准
- •Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview.
- •Previous or current diagnosis of a psychotic disorder.
- •Receiving concurrent psychotherapy treatment for emotional issues (i.e., depression, anxiety, anger) that overlaps with the current study. This will be assessed using current treatment items on the demographic forms.
结局指标
主要结局
The Clinical Global Impression Scale- Improvement (CGI-I)
时间窗: The CGI-I will be completed at 16 weeks (post-treatment)
The CGI-I will be used as a measure of overall improvement. The CGI-I (Improvement) scale was designed to measure overall symptomatic change at a specific time as compared to baseline that is completed by a rater who is blind to treatment assignment. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). It is only a single item, and lower scores indicate more improvement.
Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF)
时间窗: The EDI-SF will be completed at 16 weeks (post-treatment).
The EDI SF is a measure of emotional reactivity and regulation. The EDI SF is based on theta scores, with a mean of 0 and SD of 1 and possible range from -1.99 to 2.105. Higher scores suggest greater dysregulation, so improvement would be measured by a decrease in scores.
次要结局
- Brief Psychiatric Rating Scale (BPRS)(The CGI-I will be completed at 16 weeks (post-treatment))
研究者
Carla Mazefsky
Professor
University of Pittsburgh