Training Executive, Attention, and Motor Skills (TEAMS): Preliminary Studies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment
研究概览
简要总结
This study is designed to evaluate two potential treatments for children with Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication. Our goal is to develop new interventions for preschoolers with ADHD that will result in enduring reductions of ADHD symptoms and associated impairments in children, and thus prevent long-term difficulties characteristic of many children with ADHD.
Both interventions involve weekly playgroups (of roughly five children) in which children engage in designated activities while parents engage in groups focusing on parent education, support, and their children's activities. It is hypothesized that both interventions will be helpful, but that only one will have lasting effects well beyond the end of active treatment.
详细描述
Children eligible for this study are:
- 4 and 5 years-old (between the ages of 48 - 72 months)
- shows signs and symptoms of hyperactivity, impulsiveness and/or inattention. To enter the study, following our evaluation, they will need to meet diagnostic criteria for ADHD
- enrolled in a preschool or daycare setting
Children are ineligible to participate in this study if they:
- are currently being treated with psychotropic medication
- have a diagnosed neurological disorder
- have an autism spectrum pr pervasive developmental disorder
- are intellectually impaired
- are highly physically aggressive
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 48 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is hyperactive
- •Child meets criteria for ADHD
- •Child attends preschool or kindergarten
- •Family speaks English at home
排除标准
- •Family does not speak English at home
- •Child does not attend preschool/kindergarten
- •Child is diagnosed with or suspected of having PDD
- •Child has IQ of less than 80
- •Child is being treated with psychotropic medication
- •Child has a diagnosed neurological disorder
- •Child is aggressive
- •Child is only inattentive and does not exhibit signs of hyperactivity
- •Parent has attended parent management classes
- •Child is not physically able to participate in group play sessions
结局指标
主要结局
Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment
时间窗: Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset)
This is a clinical rating based on data derived from parent and teacher ratings as well as a semi-structured clinical interview with the child's caretaker.
次要结局
- Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment(Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset))
研究者
Jeffrey Halperin
Distinguished Professor of Psychology
Queens College, The City University of New York