Single and Combined Effects of Positive Behavior Support, Medication and Academic Accommodation for Children With ADHD
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- Behavioral frequency count of rule violations
研究概览
简要总结
This study is the first to systematically evaluate the efficacy of single and combined academic accommodation, behavioral treatment, and medication treatment in a large sample of children with ADHD. Using a scientifically rigorous, cross-over design the impact of these approaches on ecologically valid measures of outcome (on-task behavior, quiz scores, academic productivity) will be assessed to inform effective school intervention.
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADHD Diagnosis
- •IQ >= 70
排除标准
- •Prior adverse reaction to methylphenidate
- •Autism Spectrum disorder level 2/3
- •Child is home schooled
研究组 & 干预措施
General Classroom
General classroom procedures
干预措施: Methylphenidate Hydrochloride ER (Drug)
General Classroom
General classroom procedures
干预措施: Placebo (Drug)
Placebo
Placebo capsule administered in the morning
干预措施: Behavioral classroom (Behavioral)
Placebo
Placebo capsule administered in the morning
干预措施: General Classroom (Behavioral)
Placebo
Placebo capsule administered in the morning
干预措施: Academic Accommodations (Behavioral)
Methylphenidate ER (.3 mg/kg dose)
Methylphenidate ER (.3 mg/kg dose)administered in the morning
干预措施: Behavioral classroom (Behavioral)
Methylphenidate ER (.3 mg/kg dose)
Methylphenidate ER (.3 mg/kg dose)administered in the morning
干预措施: General Classroom (Behavioral)
Methylphenidate ER (.3 mg/kg dose)
Methylphenidate ER (.3 mg/kg dose)administered in the morning
干预措施: Academic Accommodations (Behavioral)
General Classroom
General classroom procedures
干预措施: Academic Accommodations (Behavioral)
Positive Behavior Support Classroom
Positive Behavior Support Classroom procedures
干预措施: Methylphenidate Hydrochloride ER (Drug)
Positive Behavior Support Classroom
Positive Behavior Support Classroom procedures
干预措施: Placebo (Drug)
Positive Behavior Support Classroom
Positive Behavior Support Classroom procedures
干预措施: Academic Accommodations (Behavioral)
Academic accommodations
Academic accommodations are used during seat work and quiz
干预措施: Methylphenidate Hydrochloride ER (Drug)
Academic accommodations
Academic accommodations are used during seat work and quiz
干预措施: Behavioral classroom (Behavioral)
Academic accommodations
Academic accommodations are used during seat work and quiz
干预措施: Placebo (Drug)
Academic accommodations
Academic accommodations are used during seat work and quiz
干预措施: General Classroom (Behavioral)
结局指标
主要结局
Behavioral frequency count of rule violations
时间窗: Through study completion, a maximum of eight weeks
Behavioral frequency count of rule violations. Lower scores are better.
Seatwork completion
时间窗: Through study completion, a maximum of eight weeks
Percentage of assigned seat work items completed correctly. Range of scores is from 0-100%. Higher scores are better.
Quiz Scores
时间窗: Through study completion, a maximum of eight weeks
Percentage correct out of 10 quiz questions. Range of scores is from 0-100%. Higher scores are better.
次要结局
未报告次要终点