跳至主要内容
临床试验/NCT01542528
NCT01542528已完成不适用

Integrated Brain, Body and Social Intervention (IBBS) for Attention Deficit Hyperactivity Disorder (ADHD)

Yale University8 个研究点 分布在 2 个国家目标入组 117 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
117
试验地点
8
主要终点
Improvement in ADHD Severity From Baseline to End of Intervention

研究概览

简要总结

The investigators are conducting this randomized trial to determine if IBBS (Integrated Brain, Body, and Social)intervention is an effective treatment for ADHD (attention Deficit Hyperactivity Disorder) in two culturally distinct settings; Hamden and New Haven, Connecticut and Beijing, China. A subgroup of the children in the US will also participate in an EEG study before and after IBBS and will be compared to a group of typically developing children.

IBBS combines computer-presented brain exercises with a physical education curriculum, all of which is designed to be fun, as well as to enhance sustained attention, inhibitory control and other executive capacities.

IBBS is a school-based program in which groups children (composed of children with ADHD, children at risk for ADHD, and typically developing children) alternate between a classroom setting and the gymnasium four days a week for 15 weeks. These mixed age groups will be composed of children with ADHD, children at-risk for ADHD, and typically developing children. Although IBBS takes place in a group setting, the computer game component individualizes instruction to maximize benefit for each child.

During the last year of the grant, we will be introducing a pilot study of an organizational skills training (OST) that will provide individualized parent and child training for improved executive functioning in children randomized to the OST plus home-based program.

详细描述

Purpose Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by a failure to develop age-appropriate executive functions. Children with ADHD struggle to sustain and direct attention, to inhibit response to task-irrelevant stimuli and to contain and down regulate impulsive behavior. ADHD can interfere with healthy emotional and cognitive development. It often has a negative impact not only on a child's academic performance but also on peer and family relationships.

Medications are now widely used to treat ADHD in the US. However, we are evaluating another approach. Based on nearly 30-years of research by scientists at Yale and in China, our Integrated Brain, Body, and Social (IBBS) Intervention for ADHD combines computer-presented brain exercises with a physical education curriculum, all of which is designed to be fun, as well as to enhance sustained attention, inhibitory control and other executive capacities. Work by other investigators has also shown that computer exercises designed specifically to address aspects of neurocognitive dysfunction in ADHD can lead to improvements in working memory and sustained attention; however IBBS is the first intervention to combine advanced computer games with sports activities.

IBBS is a school-based program in which groups of 10 children (Kindergarten, First, and Second graders) alternate between a classroom setting (45 mins) and the gymnasium (45 mins) four days a week for 15 weeks. These mixed age groups will be composed of children with ADHD, children at-risk for ADHD, and typically developing children. Although IBBS takes place in a group setting, the computer game component individualizes instruction to maximize benefit for each child.

Since the social context has a clear impact on the expression of ADHD, we have also incorporated the "Good Behavior Game" (GBG) into these group activities. The GBG is intended to facilitate group participation and to enhance co-operative interactions both in the classroom and the gymnasium. The use of the GBG is another innovative feature of IBBS. Thus far, our preliminary results have shown that IBBS leads to a fundamental increase in cognitive abilities and focused attention.

We are conducting this randomized trial to determine if IBBS is an effective treatment for ADHD in two culturally distinct settings; Hamden, Connecticut and Beijing, China. A subgroup of the children in Hamden and New Haven will also participate in an EEG study before and after IBBS. Typically Developing Children will also be recruited from the community for the optional EEG study in order to ensure that the comparison group is well-matched with regard to age, gender, and intelligence quotient (IQ) to those children with ADHD who have already participated in the EEG study.

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
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Boys and girls between 5 and 10 years of age, inclusive.
  • Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Diagnosis of ADHD (definite, probable, possible) based on a best estimate diagnosis using all available information.
  • IQ of greater or equal to 80 on the Abbreviated IQ Test
  • Currently not receiving any psychotropic medication or on a stable dose of medication prescribed for ADHD (psychostimulants, alpha agonists, atomoxetine, modafinil) for > 4 weeks.

排除标准

  • English is a secondary language
  • Current DSM-IV diagnosis requiring alternative treatment, e.g., Major Depression, Bipolar Disorder, Autism Spectrum Disorder, or a psychotic disorder.
  • Presence of serious behavioral problems (tantrums, aggression, self-injury) for which another treatment is warranted or which could be too disruptive of the group treatment settings.
  • Significant medical condition or injury identified by school personnel (that would normally identify these issues such as the school nurse, physical education teacher, or child's primary pediatrician) that would prohibit or limit the child's ability to perform the physical activity component of the IBBS (e.g. uncontrolled asthma or a musculoskeletal injury or condition.)
  • Any restrictions that have been previously identified by the child's pediatrician to school personnel will, of course, be followed.
  • Children with conditions normally prohibiting exercise will be excluded.

结局指标

主要结局

Improvement in ADHD Severity From Baseline to End of Intervention

时间窗: End of intervention is at a maximum of 15 weeks from baseline.

ADHD severity was measured by the Swanson, Nolan, and Pelham Rating Scale (SNAP)-IV-ADHD consists of 18 items that closely parallel in wording the diagnostic symptoms for ADHD as they appear in the DSM-IV. The range of scores are from 0 to 54. Higher scores indicate greater ADHD severity . The blinded assessors (Clinicians) used clinical judgement to provide an overall rating, based on all available information from the parents, teachers, and the assessors' own direct interactions with the child on the day of the assessment.

次要结局

  • Overall Improvement(15 weeks for a total of 60 IBBS sessions vs. treatment as usual (TAU))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

Loading locations...

相似试验