Study of Cognition and Control in Youths

NCT03393390 | Completed

• 2 other identifiers: HUM000881885R01MH107741
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder; Conduct Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Single fMRI session lasting no more than 2 hours

Study Arms (2)

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.

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.

Diagnostic Test: Clinical Assessment Visit; Other: fMRI scan

Interventions

Clinical Assessment Visit DIAGNOSTIC_TEST

Subjects will meet with a clinician who will determine if they meet diagnostic criteria for an externalizing disorder.

Externalizing; Healthy Controls

fMRI scan OTHER

Subjects will undergo an fMRI scan where images will be taken for observational purposes only, not as a means of diagnosis.

Externalizing; Healthy Controls

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample, clinic patients.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Oppositional Defiant Disorder; Conduct Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Chandra Sripada, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Philosophy

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 8, 2018
• Study Start: March 17, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

US (1)