Brain Changes in Children and Adolescents With Behavioral Problems
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|ClinicalTrials.gov Identifier: NCT00104039|
Recruitment Status : Completed
First Posted : February 21, 2005
Last Update Posted : September 20, 2018
|First Submitted Date||February 19, 2005|
|First Posted Date||February 21, 2005|
|Last Update Posted Date||September 20, 2018|
|Study Start Date||February 17, 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00104039 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Brain Changes in Children and Adolescents With Behavioral Problems|
|Official Title||Investigating the Neuro-Cognitive Underpinnings of the Emotional Dysfunction Linked to Childhood Behavioral Disturbance|
This study will examine brain activity in children age 10-18 with disruptive behavior problems, including conduct disorder (CD), oppositional defiant disorder (ODD), and attention deficit hyperactivity disorder (ADHD), compared with children without behavioral problems. Our goal is to examine differences in how emotions, social situations, and problem-solving situations are processed in the brain across these groups of children.
The goal of this protocol is to investigate the neuro-cognitive underpinnings of the emotional dysfunction linked to childhood behavioral disturbance; in particular, Conduct Disorder with elevated callous-unemotional (CU) traits (CD+CU), Conduct Disorder with non elevated CU traits (CD-CU), but also ADHD. The functional hypotheses that we are testing with both neuro-cognitive and neuro-imaging paradigms are that: (1) CD+CU, but not ADHD, is associated with dysfunction in the formation and operational use of stimulus-punishment and, to a lesser extent, stimulus-reward association information; (2) CD-CU is associated with heightened threat sensitivity and impairment in executive systems involved in emotional regulation; and (3) that ADHD and CD-CU, is associated with impairment in executive systems related to the representation and execution of task demands.
160 children with Conduct Disorder (CD) and high CU traits (the CD+CU group); 160 children with CD and low CU traits (the CD-CU group); 160 children with ADHD; and 160 healthy volunteer children. All children will be between the ages of 10 and 17. Both males and females will be enrolled.
The current study will have two phases: i) neuropsychological assessment and training in an MRI simulator (up to 4 hours); ii) The MRI scanning session (up to 2 hours, no more than 90 minutes in scanner). Participants, if they are willing, may be invited to participate in more than one scanning session (up to a maximum of 3 120 minute sessions) or neuro-cognitive testing session.
Behaviorally, we predict that children with CD+CU and children with CD-CU will present with impairment on tasks that involve either the formation or operational use of particular stimulus-punishment associations (e.g., the subjective value learning task and emotional interrupt task). However, the nature of this impairment with be qualitatively different. For example, we predict that youth with CD+CU will show reduced interference by emotional distracters on the emotional interrupt task but that youth with CD-CU will show decreased interference. In contrast, we predict that children with ADHD, but no CD, will show no behavioral impairment on such tasks. However, we predict that children with ADHD and children with CD-CU will present with impairments on executive function tasks (e.g., the Number Stroop paradigm). In contrast, we predict that children with CD+CU will show no impairment on these tasks. At the anatomical level, we anticipate reduced activation of emotional related systems in children with CD+CU, but increased activation in children with CD-CU, during emotional impact tasks (in particular, reduced activation of the amygdala, regions of orbitofrontal cortex and anterior cingulate). We anticipate that the neural response of children with ADHD during these tasks will be less anomalous. We anticipate that the neural response of children with ADHD and children with CD-CU during the performance of response control tasks to be anomalous (with considerable greater recruitment of anterior and posterior compensatory systems).
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||July 21, 2016|
|Primary Completion Date||Not Provided|
|Ages||8 Years to 18 Years (Child, Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||050105
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )|
|Study Sponsor||National Institute of Mental Health (NIMH)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 21, 2016|