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临床试验/NCT00895908
NCT00895908已完成不适用

Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills

Penn State University0 个研究点目标入组 171 人开始时间: 2009年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
171
主要终点
Attention deficit hyperactivity disorder (ADHD) symptomatology

研究概览

简要总结

This study will determine the effectiveness of an intervention for preventing at-risk kindergarten and pre-kindergarten children from developing attention deficit hyperactivity disorder.

详细描述

Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsiveness, and hyperactivity. ADHD is not commonly diagnosed until a child has entered formal schooling and shown academic and behavioral adjustment difficulties, but developmental research suggests that risk factors for developing ADHD are evident earlier. A significant number of children start school with high levels of disorganized and inattentive behaviors, which are symptoms of emerging ADHD. This study will test an intervention aimed at preventing the development of ADHD by identifying those at risk for developing ADHD in kindergarten and pre-kindergarten and teaching them self-regulation skills through socialization. These skills have been associated with school success, and they may reduce the likelihood of children developing ADHD.

Participation in this study will last for 4 months, with a follow-up assessment after 1 year. To enroll, child participants will undergo a screening process that will include assessments by their teachers and parents. Eligible child participants will also be assessed by researchers in a classroom setting. They will then be randomly assigned to receive either a play-based intervention, called the Friendship Group, or an individual pre-academic tutoring intervention. Both groups will meet at school. The Friendship Group, which will focus on strengthening attention and self-regulation through social skills, will involve 30 sessions twice a week for 15 weeks. The tutoring intervention, which will focus on strengthening academic skills, will involve one or two sessions a week for 4 months. Participants will be assessed at three time points: pre-intervention, post-intervention, and after 1 year. Assessments will include teacher ratings and direct testing of child attention, language, and pre-academic skills.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical or subclinical levels of ADHD symptomatology, based upon teacher and parent report

排除标准

  • Presence of sensorimotor disability, frank neurological disorder, or psychosis
  • Estimated Full Scale Intelligence Quotient (FSIQ) less than 70
  • Very low levels of English proficiency that preclude completion of the assessment battery
  • In a temporary custody situation with uncertain outcome

结局指标

主要结局

Attention deficit hyperactivity disorder (ADHD) symptomatology

时间窗: Measured pre- and post-treatment and at 12-month follow-up

次要结局

  • Social competence(Measured pre- and post-treatment and at 12-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Bierman

Professor

Penn State University

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