ADHD Treatment: Comparative and Combined Dosage Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Social Behavior-Negative Verbalizations
研究概览
简要总结
The purpose of this study is to determine the effectiveness of behavioral treatment, drug treatment, and combined treatment for children with Attention Deficit Hyperactivity Disorder (ADHD). This study will also examine the interactions between different levels of behavioral and drug treatments.
详细描述
Participants attend a summer treatment program each Monday-Friday for 9 weeks. They participate in group recreational and classroom activities, with 12 children and 5 staff per group. Three behavioral conditions (no behavioral modification, low-intensity behavioral modification, and high-intensity behavioral modification) are delivered in random order, with each condition lasting 3 weeks. Along with the behavioral treatment conditions, children receive 1 of 4 medication doses (placebo, 0.15 mg/kg methylphenidate, 0.3 mg/kg methylphenidate, or 0.6 mg/kg methylphenidate) in random order, with each dose varied daily and repeated 3 or 4 times within each behavioral treatment condition.
Measures include frequency counts of positive and negative behaviors, academic productivity and accuracy in the classroom, and counselor, parent, and teacher ratings of benefits and side effects. Parents attend training sessions and implement behavioral programs at home.
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
- Triple (Participant, Care Provider, 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
- •Attention Deficit Hyperactivity Disorder
- •IQ >= 80
排除标准
- •History of seizures or other neurological problems
- •Medical history that would involve considerable risk in taking stimulant medication
- •History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder
研究组 & 干预措施
No Treatment
No Medication, No Behavior Modification (BMOD)
干预措施: Placebo (Drug)
Low Dose Medication Only
0.15 mg/kg methylphenidate (MPH), No BMOD
干预措施: Methylphenidate 0.15 mg/kg (Drug)
Medium Dose Medication Only
0.3 mg/kg MPH, No BMOD
干预措施: Methylphenidate 0.3 mg/kg (Drug)
High Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, High Intensity BMOD
干预措施: High Intensity BMOD (Behavioral)
Higher Dose Medication Only
0.6 mg/kg MPH, No BMOD
干预措施: Methylphenidate 0.6 mg/kg (Drug)
Low Intensity BMOD Only
Placebo, Low Intensity BMOD
干预措施: Low-Intensity BMOD (Behavioral)
Low Intensity BMOD Only
Placebo, Low Intensity BMOD
干预措施: Placebo (Drug)
Low Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, Low Intensity BMOD
干预措施: Methylphenidate 0.15 mg/kg (Drug)
Low Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, Low Intensity BMOD
干预措施: Low-Intensity BMOD (Behavioral)
Low Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, Low Intensity BMOD
干预措施: Low-Intensity BMOD (Behavioral)
Low Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, Low Intensity BMOD
干预措施: Methylphenidate 0.3 mg/kg (Drug)
Low Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, Low Intensity BMOD
干预措施: Low-Intensity BMOD (Behavioral)
Low Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, Low Intensity BMOD
干预措施: Methylphenidate 0.6 mg/kg (Drug)
High Intensity BMOD Only
Placebo, High Intensity BMOD
干预措施: High Intensity BMOD (Behavioral)
High Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, High Intensity BMOD
干预措施: Methylphenidate 0.15 mg/kg (Drug)
High Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, High Intensity BMOD
干预措施: High Intensity BMOD (Behavioral)
High Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, High Intensity BMOD
干预措施: Methylphenidate 0.3 mg/kg (Drug)
High Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, High Intensity BMOD
干预措施: Methylphenidate 0.6 mg/kg (Drug)
High Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, High Intensity BMOD
干预措施: High Intensity BMOD (Behavioral)
结局指标
主要结局
Social Behavior-Negative Verbalizations
时间窗: Daily for 45 days
Sum of daily frequency of Verbal Abuse toward staff members, Teasing toward peers, and Cursing/Swearing as defined by a behavioral point system that doubles as an objective measure of children's behavior. All instances of these behaviors were reported and noted as they occur throughout daily activities.
Classroom Behavior
时间窗: Daily for 45 days
Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.
次要结局
- Treatment Satisfaction(End of Treatment)