Attention Deficit Hyperactivity DisorderNCT03393390
Study of Cognition and Control in Youths
An observational study of Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Conduct Disorder
- What is being tested?
- Clinical Assessment Visit and fMRI scan
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2016to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Community sample, clinic patients.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Clinical Assessment Visit, fMRI scan
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Oppositional Defiant Disorder, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Assessment VisitDiagnostic test
Subjects will meet with a clinician who will determine if they meet diagnostic criteria for an externalizing disorder.
fMRI scanOther
Subjects will undergo an fMRI scan where images will be taken for observational purposes only, not as a means of diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | 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. Receives: Diagnostic Test: Clinical Assessment Visit; Other: fMRI scan | |
| Externalizing | 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. Receives: Diagnostic Test: Clinical Assessment Visit; Other: fMRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single fMRI session lasting no more than 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start17 Mar 2016
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Chandra Sekhar Sripada, University of Michigan
- Investigators
- Chandra Sripada, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393390
- Sponsor's protocol ID
- HUM00088188
- Other IDs
- 5R01MH107741
- Status last verified
- Apr 2022
- First submitted
- 20 Dec 2017
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cognition and Control in Youths
- ClinicalTrials.gov ID
- NCT03393390
- Acronym / sponsor ID
- HUM00088188
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Diagnostic Test: Clinical Assessment Visit, Other: fMRI scanSubjects 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. |
| Externalizing | – | Diagnostic Test: Clinical Assessment Visit, Other: fMRI scanSubjects 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Community sample, clinic patients.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Assessment VisitSubjects will meet with a clinician who will determine if they meet diagnostic criteria for an externalizing disorder. | Diagnostic test | Externalizing, Healthy Controls |
| fMRI scanSubjects will undergo an fMRI scan where images will be taken for observational purposes only, not as a means of diagnosis. | Other | Externalizing, Healthy Controls |
Primary outcome
Maturation Curves for regulatory control structures in brain
Time frame: Single fMRI session lasting no more than 2 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandra Sripada, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maturation Curves for regulatory control structures in brain (time frame: Single fMRI session lasting no more than 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.