Cognitive Restructuring in ADHD: Functional Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Response inhibition
研究概览
简要总结
The objective of the Cognitive Restructuring in ADHD: Functional Training (CRAFT) study is to develop a non-pharmacological intervention program for children with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a childhood onset clinical disorder of inattention, hyperactivity, and impulsivity. The present study will investigate the validity, feasibility and efficacy of this novel intervention.
详细描述
This study will consist of a pre-post design and will include three phases. Participants will be tested individually at SickKids at baseline and post-training, the training phase will take place at the participants' respective homes. Each participant's parent will complete a demographic/medical questionnaire. The cognitive and behavioural outcome measures of interest in this study will be the following:
Planning and Organization: Tower Test from the Delis-Kaplan Executive Function System (D-KEFS; Delis et al, 2001) is a test of planning and problem solving abilities. Participants are asked to construct towers of discs on a set of pegs corresponding to a model. Raw scores reflect the participant's ability to use the fewest possible moves to achieve the tower depicted in the model.
Response Inhibition: Inhibitory control will be measured using the Stop Signal Task (SST). The SST measures the ability to cancel an already initiated motor response. The primary outcome measure will be the participants' mean stop signal reaction time (SSRT).
Inattentive and Hyperactivity Behaviour: Items associated with inattentiveness and hyperactivity from the Swanson, Nolan and Pelham Teacher and Parent Rating Scale version 4 (SNAP IV) will be used to estimate behavioural symptoms associated with ADHD.
Academic Performance: Academic efficiency and accuracy will be assessed using the fluency measures from the Woodcock Johnson III (WJ III) test of achievement.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 6-12 years old
- •Subject has a diagnosis of Attention Deficit Hyperactive Disorder
- •Subject is a previous POND baseline study (Attention Deficit Hyperactive Disorder Cognitive deficit and syndrome definition) participant.
- •Parent/legal guardian and subject are willing to consent/assent to participate in this study
排除标准
- •IQ below 80 on both verbal and performance scales of the Wechsler Intelligence Scale for children (WISC)-IV/V or Wechsler Abbreviated scale of intelligence (WASI II)
- •History of psychosis, schizophrenia or other major mental health diagnosis that will prevent participation/completion of the protocol
- •Subject's current medical problems that would preclude his/her participation in the study
- •Child younger than 6 years old or older than 12
- •Parent/legal guardian and/or subject not willing to consent/assent to participate in this study
研究组 & 干预措施
Treatment group
Subjects randomly assigned to this arm will train on the Mega Team video game.
干预措施: Mega Team-videogame (Other)
Control-waitlist group
Subjects randomly assigned to this arm will be the wait-list group. They are allowed to play the video games that they usually play.
结局指标
主要结局
Change in Response inhibition
时间窗: Baseline and post-training study visits (4-5 weeks apart)
Inhibitory control will be measured using the Stop Signal Task.
Change in Working memory
时间窗: Baseline and post-training study visits (4-5 weeks apart)
Target accuracy as measured by the N-Back Tasks
次要结局
- Change in Planning and Organization(Baseline and post-training study visits (4-5 weeks apart))
- Change in Inattentive and Hyperactivity Behaviour(Baseline, week1, week 2, week 3, week 4, and at post-training study visit (week 4-5))
- Change in Academic performance(Baseline and post-training study visits (4-5 weeks apart))
- Change in Spatial Span(Baseline and post-training study visits (4-5 weeks apart))
研究者
Jennifer Crosbie
Psychologist
The Hospital for Sick Children