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临床试验/NCT02457676
NCT02457676已完成不适用

Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention

The Hospital for Sick Children0 个研究点目标入组 65 人开始时间: 2009年10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
65
主要终点
Emotion regulation

研究概览

简要总结

This study on children with fetal alcohol spectrum disorder (FASD) aims to (i) characterize their self-regulation deficits, a process important for controlling emotions and behavior, (ii) describe brain structure and function underlying self-regulation, and (iii) determine whether training to improve self-regulation abilities changes brain and behavior. Individuals with FASD have a high risk of cognitive and social deficits, which reflect their difficulties in self-regulation and may lead to mental health concerns in adulthood. Importantly, early intervention improves long-term outcome. However the full extent of self-regulation problems in FASDs is unknown and the underlying neuroanatomy has not been fully described. Furthermore, information on how to best treat children with FASDs is lacking. Thus, the investigators propose three studies with a sample of 8-12 year old children, 40 with FASDs and 20 typically developing controls. In Study 1, the participants will be evaluated on cognitive and social self-regulation abilities using clinical and experimental tests. In Study 2, the participants will undergo a 1-hour MRI scanning session to obtain measures of their brain structure and function. In Study 3, FASDs will be randomly assigned to an immediate or delayed treatment group. The immediate group will undergo 12-weeks of therapy with the Alert Program for Self Regulation®. On conclusion of training, all will repeat Studies 1 and 2 and following this retest, the delayed treatment group will undergo training. The investigators will evaluate change in cognitive and social behavior and in brain structure and function by comparing performance and neuroimaging findings before and after the intervention. The investigators expect Alert training to significantly improve behavior and alter brain regions important for self-regulation. The findings will yield important information for improving self-regulation in FASDs and mitigating the development of mental health challenges.

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
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • FASD: diagnosis of FAS/pFAS or ARND OR
  • healthy child

排除标准

  • head injury or other neurological abnormality
  • debilitating or chronic medical condition affecting the nervous system
  • MRI contraindication, such as braces
  • inability to read
  • non-English speaking
  • IQ below 80 (typically developing controls only)

结局指标

主要结局

Emotion regulation

时间窗: 14 weeks after initial testing

Evaluated by parent questionnaires

次要结局

  • Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF(14 weeks after initial testing)
  • Social cognition: Saltzman's Social Cognitive Task; NEPSY(14 weeks after initial testing)
  • Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist(14 weeks after initial testing)
  • Brain structure: Voxel-based morphometry(14 weeks after initial testing)
  • Brain structure: Cortical thickness(14 weeks after initial testing)
  • Brain function: Functional MRI(14 weeks after initial testing)

研究者

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

Joanne Rovet

Senior Scientist

The Hospital for Sick Children

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