An observational study in Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder and Conduct Disorder, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by University of Michigan · Observational
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.
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.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's enrollment of 256 is above the median of 127 across 329 observational studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
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Community sample, clinic patients.
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Exclusion Criteria:
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Clinical Assessment Visit · Other: fMRI scan
Subjects in this group will be defined as externalizing if the clinician determines that they meet the diagnostic criteria for one or more externalizing disorders, such as ADHD, ODD, or CD.
Diagnostic Test: Clinical Assessment Visit · Other: fMRI scan
Subjects will meet with a clinician who will determine if they meet diagnostic criteria for an externalizing disorder.
Subjects will undergo an fMRI scan where images will be taken for observational purposes only, not as a means of diagnosis.
Maturation Curves for regulatory control structures in brain
Resting state fMRI functional connectivity maps will be used to generate normative growth curves for each component in the brain's regulatory control architecture using a multi-level linear mixed effects model. Each individual's deviation from their expected growth (based on the normative growth chart) is calculated and is utilized to predict clinical outcome variables.
Time frame: Single fMRI session lasting no more than 2 hours
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2016 to primary completion in Sep 2019, 42 months.
Of 85 non-industry observational studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 69. This study's 42 months is above that.
Counting every sponsor, half of 95 studies reached it within 35 months; a quarter within 20 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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