Central Executive Training for ADHD: Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 2
- 主要终点
- ADHD symptoms
研究概览
简要总结
The goal of the current project is to assess the efficacy of Central Executive Training (CET) for youth with ADHD. CET is a new, computerized training intervention that targets specific components of the working memory system. Two versions of CET were developed as part of our R34, each targeting a different combinations of executive functions. The final CET protocol reflects the contributions and feedback of a diverse group of caregivers, children with ADHD, and recognized experts in human cognition, ADHD treatment research, randomized control trial (RCT) intervention design methods, serious game theory and task design, cognitive training, and the role of executive dysfunction in ADHD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 8-12 with principal ADHD diagnoses (via Kiddie Schedule for Affective Disorders semi-structured clinical interviewing (K-SADS)
- •Parent AND teacher ratings in clinical/borderline range based on age and gender on ADHD-RS-5 or BASC-3 Attention Problems/Hyperactivity subscales
- •Below average or lower working memory on at least one pre-treatment WM test. All ADHD presentations will be eligible.
排除标准
- •gross neurological, sensory, or motor impairment
- •history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (substance use, disruptive mood dysregulation, intermittent explosive, reactive attachment)
- •intellectual disability or Wechsler Intelligence Scale for Children (WISC-V) short-form intelligence quotient (FSIQ) < 78 (1.5 standard deviations (SD) below mean)
- •conditions requiring acute intervention, e.g., active suicidality
- •non-English speaking child or parent.
结局指标
主要结局
ADHD symptoms
时间窗: Immediate post-treatment (within 2 weeks of final treatment session)
Average of T-scores on parent-report ADHD symptoms questionnaires (Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-5) Inattention and Hyperactivity subscales, Behavioral Assessment System for Children (BASC-3) Inattention and Hyperactivity subscales)
次要结局
- Actigraph-measured hyperactivity during working memory testing(Immediate post-treatment (within 2 weeks of final treatment session))
- Working Memory(Immediate post-treatment (within 2 weeks of final treatment session))
- Inhibitory control(Immediate post-treatment (within 2 weeks of final treatment session))
- Actigraph-measured hyperactivity during baseline(Immediate post-treatment (within 2 weeks of final treatment session))
研究者
Michael J. Kofler
Associate Professor
Florida State University