Study of Cognition and Control in Youths

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Brief Title

Study of Cognition and Control in Youths

Official Title

Study of Cognition and Control in Youths

Brief Summary

      The purpose of this study is to learn more about the functioning of particular types of
      regions of the brain, specifically, those related to externalizing disorders such as
      Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiance Disorder (ODD), and
      Conduct Disorder (CD). Brain function of children and adolescents with externalizing
      disorders such as ADHD, ODD, and CD will be compared to the brain function of those without.
      Functional Magnetic Resonance Imaging (fMRI) will be used to monitor brain activity at work
      and at resting states.
    

Detailed Description

      The goal of this research proposes to take a developmental neuroimaging approach to
      elucidating brain mechanisms that lead to distinct forms of impulsivity in youth with
      externalizing disorders, including attention-deficit/hyperactivity disorder (ADHD),
      oppositional defiant disorder (ODD), and conduct disorder (CD). Roughly 12-15% of youth
      suffer from at least one of these disorders (many of them have more than one) and they go on
      to experience serious adverse outcomes over the course of their lifetimes including increased
      rates of substance abuse, violence and criminality, maladjustment, and suicide. The absence
      of a biological, and in particular a neurodevelopmental, understanding of the pathophysiology
      of distinct kinds of impulsivity has been a major barrier to improving clinical care for
      impulsive youth; it has hindered efforts at building better nosology, earlier and more
      reliable diagnosis, and more effective treatments.

      The NIMH Research Domain Criteria (RDoC) Initiative encourages clinical scientists to no
      longer think in terms of single categorical diagnoses (whose boundaries may in fact be drawn
      incorrectly), but rather to identify disorder-spanning constructs. Inspired by the RDoC
      Initiative, our research aims to delineate the neural mechanisms of distinct forms of
      impulsivity in youth from a transdiagnostic perspective that spans the three main
      externalizing disorders, ADHD, CD, and ODD, as well as across subtypes of these disorders
      (e.g., ADHD inattentive, hyperactive/impulsive, and combined types). More specifically, the
      study aims to develop a new class of imaging-based biomarkers for specific forms of
      impulsivity-markers that are rooted in aberrant brain maturation patterns.

      Developing neuroimaging markers of impulsivity could have a number of important clinical
      impacts. For example, these markers could provide a basis for more objective diagnosis,
      facilitate earlier diagnosis, catalyze the development of new treatments, and help to guide
      the selection of treatments.

      For this study, 270 youth subjects will be recruited, 135 with at least one externalizing
      disorder and 135 matched controls, between the ages of 6-18 . All participants will receive
      the following: 1) a comprehensive clinical/neurological assessment to quantify impulsivity
      symptoms; and 2) an fMRI session (structural, diffusion tensor imaging, resting, and task).
      Three cohorts are recruited: childhood (6-9 years; n=90), early adolescence (10-13 years;
      n=90), and middle adolescence (14-18; n=90).

      The main aim of the study is to use imaging results to generate normative maturational curves
      for each component in the brain's regulatory control architecture using a multi-level linear
      mixed effects model. Multivariate models that predict types of impulsivity based on component
      expression will then be constructed.
    


Study Type

Observational


Primary Outcome

Maturation Curves for regulatory control structures in brain


Condition

Attention Deficit Hyperactivity Disorder

Intervention

Clinical Assessment Visit

Study Arms / Comparison Groups

 Healthy Controls
Description:  Subjects in this group will be defined as healthy controls after meeting with a clinician and determining that they do not meet the diagnostic criteria for any externalizing disorders or other psychiatric disorders.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

270

Start Date

March 17, 2016

Completion Date

March 2022

Primary Completion Date

March 2022

Eligibility Criteria

        Inclusion Criteria:

          -  The healthy control group will be made up of approximately 135 subjects between the
             ages of 6-18 at the start of the study who meet no diagnostic criteria for any
             externalizing disorders.

          -  The externalizing group will be made up of approximately 135 subjects between the ages
             of 6-18 at the start of the study who meet the diagnostic criteria for at least one
             externalizing disorder (ADHD, ODD, CD, etc)

        Exclusion Criteria:

          -  IQ below 80

          -  History of significant head injury (e.g. loss of consciousness greater than 5 minutes,
             report of skull fracture or cerebral hemorrhage, or hospitalization)

          -  Presence of any significant medical or neurological condition that might impact
             activity in the neural circuits of interest or that might increase risk of
             participation for the subject (e.g. seizure disorder or mass lesions)

          -  Contraindications to MRI (e.g. metal objects in body, claustrophobia)

          -  Abnormal vision after correction
      

Gender

All

Ages

6 Years - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Chandra Sripada, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03393390

Organization ID

HUM00088188


Responsible Party

Principal Investigator

Study Sponsor

University of Michigan


Study Sponsor

Chandra Sripada, PhD, Principal Investigator, University of Michigan


Verification Date

April 2021