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临床试验/NCT05927506
NCT05927506已完成不适用

Adolescent Changes in Brain and Behavior in Boys and Girls With ADHD

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.1 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2015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
312
试验地点
1
主要终点
Response Control and Frustration Tolerance

研究概览

简要总结

The purpose of the study is to examine the developmental trajectory of response control in boys and girls with ADHD entering adolescence. The investigators also want to determine the developmental trajectory of brain anatomy and brain connectivity in boys and girls with ADHD entering adolescence.

详细描述

Children with Attention Deficit Hyperactivity Disorder (ADHD) are at risk for a host of deleterious outcomes including impaired social relations, academic difficulties, criminality, and comorbid psychopathology (substance use, depression, anxiety). Many of these difficulties emerge and exacerbate during adolescence; therefore, it is crucial to understand the developmental trajectory of ADHD-associated changes in brain and behavior during this sensitive period. Further, there is increasing recognition that sex may be an important moderator of the clinical manifestations of ADHD, with adolescent boys showing more impulsive risk-taking while girls show more emotional dysregulation.

Identification of patterns of brain and behavioral development associated with risk for poor outcome in both boys and girls with ADHD shows the profound public health significance of our research. Furthermore, the investigators are proposing to examine the dimensional construct of response control in children with ADHD from multiple levels of analysis including neural structure and connectivity, behavioral expression, and relation to functional outcomes, with the ultimate goal of identifying bio-behavioral markers of impairment and adjustment in children with ADHD.

Our objectives:

Aim 1: To examine the developmental trajectory of response control in boys and girls with ADHD entering adolescence.

Aim 2: To examine how baseline abnormalities in response control and brain structure and function, as well as development trajectories for these measures, differentially predict functional outcomes in adolescent boys and girls with ADHD.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Diagnosed with or without Attention Deficit Hyperactivity Disorder
  • •Must be able to attend a follow-up after 18 months after initial visit

排除标准

  • •Diagnosed with Autism Spectrum Disorder (ASD)
  • •Diagnosed with Schizophrenia, Conduct Disorder, and/or Bipolar Disorder
  • •Diagnosed with a genetic disorder
  • •Premature birth (less than 36 weeks)

结局指标

主要结局

Response Control and Frustration Tolerance

时间窗: Completed on Day 1 or Day 2 Visit

Go/No-Go (GNG) reaction time task related to working memory and motivation. Each task will take place in a single block of 207 trials (80% green), with no rest phases (total duration = 8min, 19 sec). For the motivational GNG task, stimulus presentation will be followed by a blank screen (1000ms), the presentation of visual feedback (1700ms), and another blank screen (500ms). Reward feedback will be presented for correct "go" responses and response cost feedback will be presented for commission errors.

Developmental Trajectory of Brain Anatomy

时间窗: Completed on Day 1 or Day 2 Visit

The Primary outcome variables will be morphometry of cortical regions (thickness, surface area, folding index, volume) and subcortical regions (basal ganglia, amygdala, and hippocampus volume and shape).

Predictors of Adolescent Socio-Emotional Development

时间窗: Completed on Day 1 or Day 2 Visit

Behavior Assessment System for Children (BASC-3) is a questionnaire used to assess behavioral and emotional functioning in children. The parent-report, teacher-report, and self-report versions will be administered to collect behavioral and emotional values.

Developments of ADHD Symptoms

时间窗: Completed on Day 1 or Day 2 Visit

Conners-4 is a questionnaire to values on conduct and learning problems, impulsivity-hyperactivity, anxiety, and social competence. Parent-report and teacher-report will be administered collect values to determine ADHD symptom severity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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