Brain Changes in Children and Adolescents With Behavioral Problems
NCT ID: NCT00104039
Last Updated: 2019-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
318 participants
OBSERVATIONAL
2005-02-17
2016-07-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Developing Brain, Impulsivity and Compulsivity
NCT04631042
Study of Cognition and Control in Youths
NCT03393390
Investigating the Specificity of Neural Correlates for Emotion Processing Deficits in Conduct Disorder and Autism Spectrum Disorders
NCT04324099
Psychological Mechanisms of Behavioral Dysregulation
NCT00352456
Female Experiences and Brain Activity
NCT01395160
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
STUDY POPULATION:
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.
DESIGN:
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.
OUTCOME MEASURES:
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Individuals with CD-CU: Male and female subjects aged 8 -18 who score less than 20 on the APSD/PCL-YV. Children with antisocial behavioral problems on medications with psychotopic effects will be considered if their target behaviors persist despite the use of medications. In these children, only simple stimulant medications will be held for 48 hours. These include methylphenidate, amphetamine and their derivatives including Ritalin, Ritalin SR, Ritalin LA, Methylin, Methlin ER, Metadate-CD, Concerta, Dexedrine, Dextrostat, Dexedrine Spansule, Adderall, Adderall XR, and Focalin Medications like Starattera (atomoxetine), bupropion (Wellbutrin), modafinil (Provigil), or valproic acid (Depakote), or other mood stabilizers are not safe to stop suddenly and children taking these medications will not be asked to stop them.
3. Individuals with ADHD: Male and female subjects aged 8-18 who currently meet DSM-IV criteria for ADHD. The diagnosis will be made on the basis of a K-SADS-PL interview with the parent and a t score \>65 on the hyperactivity-impulsivity subscale of the Connors Teacher Scale. Participants in this group will have APSD scores \<20.
4. Comparison individuals: Male and female subjects aged 8-18 who are free from any current or past psychopathology (all will score less than 20 on the APSD/PCL-YV).
3. Subjects with psychopathic tendencies who receive a diagnosis of an anxiety or mood disorder as determined by a clinical and K-SAD review conducted by a psychiatrist will be excluded. Additionally, children with active psychosis, pervasive developmental disorders or Tourette s syndrome will be excluded.
4. Children with CD-CU will be evaluated through the KSAD and clinical review by a psychiatrist. Explicit exclusions include active psychosis, Pervasive Developmental Disorders and Tourette s syndrome. Children with anxiety disorders will be included given the high comorbidity of CD-CU and anxiety disorders.
5. Individuals with ADHD will be evaluated through the KSAD and clinical review by a psychiatrist. Those children who receive diagnosis of mood disorders through this evaluation process will be excluded. Additional explicit exclusions include active psychosis, Pervasive Developmental Disorders and Tourette s syndrome. Children with anxiety disorders will be included given the high comorbidity of ADHD and anxiety disorders.
7. Neurologic disorder (including seizures).
8. Any metallic objects in the body. Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.
9. Claustrophobia: participants will be questioned about potential discomfort in being in an enclosed space, such as an MRI scanner.
Exclusion Criteria
8 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James J Blair, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Mental Health (NIMH)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ambrogi Lorenzini CG, Baldi E, Bucherelli C, Sacchetti B, Tassoni G. Neural topography and chronology of memory consolidation: a review of functional inactivation findings. Neurobiol Learn Mem. 1999 Jan;71(1):1-18. doi: 10.1006/nlme.1998.3865.
Aron AR, Fletcher PC, Bullmore ET, Sahakian BJ, Robbins TW. Stop-signal inhibition disrupted by damage to right inferior frontal gyrus in humans. Nat Neurosci. 2003 Feb;6(2):115-6. doi: 10.1038/nn1003. No abstract available.
Babinski LM, Hartsough CS, Lambert NM. Childhood conduct problems, hyperactivity-impulsivity, and inattention as predictors of adult criminal activity. J Child Psychol Psychiatry. 1999 Mar;40(3):347-55.
Hwang S, Meffert H, Parsley I, Tyler PM, Erway AK, Botkin ML, Pope K, Blair RJR. Segregating sustained attention from response inhibition in ADHD: An fMRI study. Neuroimage Clin. 2019;21:101677. doi: 10.1016/j.nicl.2019.101677. Epub 2019 Jan 15.
Tyler PM, White SF, Thompson RW, Blair RJR. Applying a Cognitive Neuroscience Perspective to Disruptive Behavior Disorders: Implications for Schools. Dev Neuropsychol. 2019 Jan-Feb;44(1):17-42. doi: 10.1080/87565641.2017.1334782. Epub 2018 Feb 12.
White SF, Thornton LC, Leshin J, Clanton R, Sinclair S, Coker-Appiah D, Meffert H, Hwang S, Blair JR. Looming Threats and Animacy: Reduced Responsiveness in Youth with Disrupted Behavior Disorders. J Abnorm Child Psychol. 2018 May;46(4):741-754. doi: 10.1007/s10802-017-0335-0.
White SF, VanTieghem M, Brislin SJ, Sypher I, Sinclair S, Pine DS, Hwang S, Blair RJ. Neural Correlates of the Propensity for Retaliatory Behavior in Youths With Disruptive Behavior Disorders. Am J Psychiatry. 2016 Mar 1;173(3):282-90. doi: 10.1176/appi.ajp.2015.15020250. Epub 2015 Oct 6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
05-M-0105
Identifier Type: -
Identifier Source: secondary_id
050105
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.