Randomized Controlled Trial With Use of Cognitive Training in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in ADHD symptomatology
研究概览
简要总结
Purpose: This project assess the effectiveness of a cognitive training as an add-on intervention to drug treatment in children and adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) compared to a placebo training. The cognitive training consists of 6 computerized games that are based on principles of neuroplastic change.
ADHD: current treatment - International clinical guidelines indicate that pharmacological interventions in particular stimulants are the first-line treatment for ADHD. However, about 30% of children affected by the disorder do not respond to medication alone, exhibit partial response or can not tolerate the adverse effects. In addition there is a group of parents who do not accept the use of medication for the treatment of ADHD in their children. In recent years cognitive training has received considerable attention as a treatment to ADHD. The evidence base for cognitive training programs are still forming with few randomized placebo-controlled studies. However, this approach seems to be effective either as a treatment for ADHD - and others cognitive disorders in childhood - or as a tool to enhance cognitive ability and school performance in children and adults. No previous study has evaluated this cognitive intervention in a clinical trial with placebo-controlled intervention and as an adjunctive treatment to medication. Additionally, the investigators will assess brain changes associated with this intervention using neuroimaging (fMRI).
详细描述
Material and Methods Trial design Randomized clinical trial with placebo control. This study will compare the cognitive training program versus the placebo condition to assess the reduction on residual symptoms, the improvement in the neurocognitive function and brain activation changes in children and adolescents with ADHD receiving stimulants. Sixty subjects, six to thirteen years-old with ADHD confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) will be randomly assigned to 12 weeks of cognitive or placebo training.
Participants To be included in the study children and adolescent need to meet the following criteria (a) age between 6-13 years, (b) a diagnosis of ADHD classified according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (5th edition), (c) medicated and stabilized with psychostimulants but partially restored - inattention SNAP score (mean scores of parents and teachers > or = 1), (d) a full scale intelligence quotient (IQ) of at least 80, (e) access to a computer with windows vista 7 and speakers, and access to internet. Participants will be excluded in case (a) another comorbid psychiatry diagnosis clinically significant and requiring treatment at the time of enter in the study protocol.
Sample Size Calculation There was no previous study that used the design proposed in this investigation. Considering a reduction 20% higher of the SNAP-IV scores in the active group intervention (stimulants + cognitive training), sample size in both groups of 27 participants and standard-deviation in the magnitude of half of the medium score in each group (moderate variability), the study will be able to detect a moderate effect size (ES = 0,4). Calculating a sample loss of 10% each group, we define a sample size per group of 30 individuals.
Cognitive intervention protocol:
A portuguese version of the new Cognitive Computerized Training was created with the partnership of Yale University research team.
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 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 6 to 13 years, ADHD diagnosis (DSM-V)
- •Medicated and stabilized individuals with psychostimulant with residual symptoms of inattention - mean scores of parents and teachers > or = 1)
排除标准
- •Presence of other comorbid mental disorder that is clinically significant and requiring treatment at the time of entry in the protocol.
- •intelligence quotient (IQ) < 80
结局指标
主要结局
Change in ADHD symptomatology
时间窗: Baseline; 12 weeks.
Measured by the SNAP scale filled by parents and teachers.
次要结局
- Change in neuropsychological function.(Baseline; 12 weeks.)
- Change in activation of front-striatal and parietal brain areas in functional magnetic resonance imaging (fMRI) during a neuropsychological test.(Baseline; 12 weeks.)
- Change in the hours and characteristic of internet use(Baseline; 12 weeks)