TEAMS (Training Executive, Attention, and Motor Skills): - Intervention Program for Preschoolers With ADHD (Attention Deficit Hyperactivity Disorder). A Rct. Proof-of-Concept Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in ADHD (Attention Deficit Hyperactivity Disorder) core symptoms: measured by ADHD-RS IV: 'Attention Deficit Hyperactivity Disorder- symptom rating scale (teacher and parent rated.)
研究概览
简要总结
Background:
TEAMS (Training Executive Attention and Motor Skills) is a non-pharmacological, neurocognitive intervention program targeted preschool children with ADHD developed by Professor Jeffrey Halperin, and his team from New York University. The uniqueness of this program lies in the concept, based on stimulating neurocognitive growth through focused physical activity and play (Halperin et al.; 2011, 2012, in press).
Teams hypotheses:
TEAMS is based on the notions that:
- The behavioural manifestations of ADHD are the result of deficient neural networks that affect a wide array of neurocognitive and behavioural processes which are not necessarily identical in all children with the disorder.
- Neurodevelopment is sensitive to and can be positively affected by appropriate environmental influences.
- Effective environmental stimulation will be best achieved within a social context.
- The engagement of the child in the core activities of the treatment must be intrinsically rewarding (i.e., fun) in order to facilitate compliance of the intervention.
The initial research by Halperin et al. (2012)indicated significant improvement in ADHD severity from pre- to post-treatment, which also persisted 3 months later.
Objective: The aim of this study is, through a randomized controlled trial (RCT), to validate the TEAMS treatment program in a clinical setting in Denmark.
Method: Pre-school children age 3-6, from Region Zealand in Denmark, diagnosed with ADHD as primary diagnosis are offered participation in the RCT study of the TEAMS program. The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand. The intervention groups participate in eight weekly group sessions consisting of separate parent- and children's groups.
In the child group the children are introduced to games that are designed to enhance inhibitory control, working memory, attention, visuospatial abilities, planning, and motor skills. The parent group consists of psychoeducation and instructions in how to encourage playing these games with their children and how to support the child's development.
详细描述
Based on a calculation of strength:
Concurring to a statistically significant outcome the estimated cohort should be minimum 87 children. Based on Region Zealand's visitation history records the cohort is expected to be approximately 100-160 children.
Group size:
The number of participants in each treatment group depends in part on how many children have been recruited. Given the constraints of our setting, treatment groups generally consist of at least two, and up to five participants.
Staffing: Two group leaders and one student-assistant are present for every five participants in the playgroup.
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
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 3-6, diagnosed with ADHD as primary diagnosis
排除标准
- •Children of parents, who are not capable of cooperating in order to implement the program.
- •Children living at residential institution or in an unstable environment outside the home.
- •Children or parents, who do not speak/understand Danish Children, who are in medical treatment for ADHD.
- •Children with significant disabilities due to comorbidity, such as autism, attachment disorder or mental retardation.
结局指标
主要结局
Change in ADHD (Attention Deficit Hyperactivity Disorder) core symptoms: measured by ADHD-RS IV: 'Attention Deficit Hyperactivity Disorder- symptom rating scale (teacher and parent rated.)
时间窗: 1 month, 3 months, 6 months
次要结局
- Compliance with TEAMS program (TCA: Treatment Compliance Assessment)(parent rated)(paticipants will be followed for the duration of the 8 week intervention)
研究者
Helle Annette Vibholm, MSc, Nurse Specialist
Msc, Nurse Specialist.
Holbaek Sygehus