Brain Changes in Children and Adolescents With Behavioral Problems

November 2, 2019 updated by: National Institute of Mental Health (NIMH)

Investigating the Neuro-Cognitive Underpinnings of the Emotional Dysfunction Linked to Childhood Behavioral Disturbance

Purpose:

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.

Study Overview

Status

Completed

Conditions

Detailed Description

OBJECTIVE:

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).

Study Type

Observational

Enrollment (Actual)

318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

    1. Individuals with CD + CU: Male and female subjects aged 8-18 who score equal to or more than 20 on the APSD/PCL-YV. Children with antisocial behavioral problems on medications with psychotropic 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 Strattera (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.
    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).

EXCLUSION CRITERIA:

  1. I.Q.< 75.
  2. Ongoing medical illness other than those listed in the inclusion criteria for the respective groups that require use of any medication that may have psychotropic effects. For example, a patient with history of mild asthma that did not require medication may be included, however a patient with asthma requiring use of beta blockers, steroids, etc. would not be included. For children with ADHD or healthy volunteer children, a contraindication to discontinuing medication for 48 hours. Only simple stimulant medications will be held for 48 hours. These include methylphenidate, amphetamine and their derivative including Ritalin, Ritalin SR, Ritalin LA, Methylin, Methlin ER, Metadate CD, Concerta, Dexedrine, Dextrostat, Dexedrine Spansule, Adderall, Adderall XR, and Focalin. Medications like Strattera (atomoxetine), bupropion (Wellbutrin), or modafinil (Provigil) are not safe to stop suddenly and children with ADHD taking these medications will not be included.
  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.
  6. Any other psychiatric disorder that is sufficiently severe to require specific treatment, with the exception of those listed in the inclusion criteria for the respective groups.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 17, 2005

Primary Completion

December 7, 2022

Study Completion

July 21, 2016

Study Registration Dates

First Submitted

February 19, 2005

First Submitted That Met QC Criteria

February 19, 2005

First Posted (Estimate)

February 21, 2005

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 2, 2019

Last Verified

July 21, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 050105
  • 05-M-0105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Conduct Disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe