Training Attentional Awareness and Control in Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Change From Baseline in Nelson-Denny Reading Test - Comprehension Score
研究概览
简要总结
The purpose of this study is to evaluate the effects of different types of cognitive training on attention in adults with Attention Deficit Hyperactivity Disorder (ADHD) using mobile software on personal mobile devices.
详细描述
Different types of software-based cognitive training are thought to impact attention via different mechanisms. This study examines the nature of the effects on sustained attention of two different types of mobile software based training. Because the nature of the training method is behavioral, the investigators can not divulge the differences in the training methods and their hypothesized differences in their impact on attention.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet established Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the Mini International Neuropsychiatric Interview, and corroborating information
- •Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
- •No lifetime history of DSM-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed with the Mini-International Neuropsychiatric Interview (MINI)
- •Able in the opinion of the investigator to complete all required study procedures.
排除标准
- •History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
- •History of any general medical condition likely to require chronic use of medication with identified Central Nervous System (CNS) effects suspected to alter cognitive performance
- •History of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
- •Serious oxygen deprivation
- •Current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
- •Current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
- •Current treatment with guanfacine.
研究组 & 干预措施
Active - SAC
Behavioral learning by using the Sustained Attention Control (SAC) Method's mobile software to increase sustained attention skills and self-awareness of attention control.
干预措施: Sustained Attention Control (SAC) Method (Behavioral)
Control - Scrabble
Behavioral learning using the mobile software game "Scrabble" to exercise word processing and executive control functions.
干预措施: Scrabble (Behavioral)
结局指标
主要结局
Change From Baseline in Nelson-Denny Reading Test - Comprehension Score
时间窗: Baseline and 10 weeks
Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The Nelson Denny Reading Comprehension test is a time-limited (20-minute) measure of an important daily life activity that is impaired in ADHD, and impacted by poor sustained attention. The score range is from 0-76 with larger values representing better performance. A larger positive difference value (Post- Pre) indicates an improvement in reading comprehension.
Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score
时间窗: Baseline and 10 weeks
Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. This is a computerized continuous performance task yielding a measure of reaction time (RT) variability over the duration of the task as an assessment of sustained attention control. Less variability in RT is a sign of better sustained attention control. The scaled scores are T Scores and the range is 0-100. Smaller values represent better performance (i.e. lower variability). Consequently, a negative difference value (Post-Pre) indicates improvement. This measure directly addresses the training target, inconsistent control of sustained attention (the variability in RT over time), and is highly correlated with ADHD.
次要结局
- Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale(Baseline and 10 weeks)
- Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale(Baseline and 10 weeks)
研究者
Gregory Simpson, Ph.D.
Founder and Chief Scientific Officer
Think Now Incorporated