The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD: A Randomised Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Mathematical performance
研究概览
简要总结
This study aims at investigating the direct effects of methylphenidate on school performance of primary school children. Although behavioral effects of this frequently prescribed drug are thoroughly studied (and confirmed), the effects of methylphenidate on school performance are less clear. Recent overviews indicate that effects are mainly quantitative and subject-specific. To gain more insight in this issue, the current double blind placebo controlled crossover study investigates not only the effects of methylphenidate on school performance but also it's effect on related variables such as short term memory, motivation and behavior. 60 children with ADHD are included and tested twice (with medication and with placebo) at their primary school.
详细描述
Rationale: ADHD (attention deficit hyperactivity disorder) is a common childhood developmental disorder. Besides the behavioural symptoms of ADHD, many children with ADHD experience problems with academic activities. More specifically, these children show problems with math, spelling and reading. The most common treatment for ADHD is medical treatment with methylphenidate (MPH). This treatment is effective in the reduction of ADHD symptoms. However, it is unclear whether treatment with MPH can also improve academic activity. If MPH improves academic activity, it is of great interest to understand which variables influence or mediate this effect. The results from this study can give more insight in the working mechanisms and effectiveness of MPH in reducing the academic problems commonly observed in children with ADHD.
Objectives: The main objective of this study is to assess the impact of MPH on academic activity and to estimate the role of three putative mediators in this relation.
Study design and population: This study is a randomised, double-blind, placebo-controlled cross-over design with a patient group and a control group. Main study parameters/endpoints: The main study parameters are changes in academic activity (ability, effort and engagement). In addition, changes in putative mediators are assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •ADHD diagnosis (DSM-IV)
- •primary school education
- •sufficient knowledge of Dutch language
排除标准
- •neurological or psychiatric disorder other than ODD, CD, learning disorder, dyslexia, anxiety disorder
- •Healthy volunteers are accepted for the control group
研究组 & 干预措施
Drug: Methylphenidate
Drug: Methylphenidate 7 days dosage as (prior to study) clinically titrated long acting Equasym (brand)
干预措施: Methylphenidate (Drug)
Drug: Placebo
Drug: Placebo 7 days Empty green-yellow capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Mathematical performance
时间窗: 3.5 years
A standardized task for mathematics is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.
Reading performance
时间窗: 3.5 years
A standardized task for technical reading ability is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.
Spelling performance
时间窗: 3.5 years
A standardized task for spelling is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.
次要结局
- Cognitive performance(3.5 years)
- Academic motivation(3.5 years)
- Classroom behavior(3.5 years)
研究者
Anne Fleur Kortekaas-Rijlaarsdam
A.F. Kortekaas-Rijlaarsdam
VU University of Amsterdam