- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05927506
Adolescent Changes in Brain and Behavior in Boys and Girls With ADHD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children with Attention Deficit Hyperactivity Disorder (ADHD) are at risk for a host of deleterious outcomes including impaired social relations, academic difficulties, criminality, and comorbid psychopathology (substance use, depression, anxiety). Many of these difficulties emerge and exacerbate during adolescence; therefore, it is crucial to understand the developmental trajectory of ADHD-associated changes in brain and behavior during this sensitive period. Further, there is increasing recognition that sex may be an important moderator of the clinical manifestations of ADHD, with adolescent boys showing more impulsive risk-taking while girls show more emotional dysregulation.
Identification of patterns of brain and behavioral development associated with risk for poor outcome in both boys and girls with ADHD shows the profound public health significance of our research. Furthermore, the investigators are proposing to examine the dimensional construct of response control in children with ADHD from multiple levels of analysis including neural structure and connectivity, behavioral expression, and relation to functional outcomes, with the ultimate goal of identifying bio-behavioral markers of impairment and adjustment in children with ADHD.
Our objectives:
Aim 1: To examine the developmental trajectory of response control in boys and girls with ADHD entering adolescence.
Aim 2: To examine how baseline abnormalities in response control and brain structure and function, as well as development trajectories for these measures, differentially predict functional outcomes in adolescent boys and girls with ADHD.
Aim 3: To examine how intrinsic functional connectivity relates to brain structure, structural connectivity, and response control in adolescent boys and girls with ADHD.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Kennedy Krieger Insititute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosed with or without Attention Deficit Hyperactivity Disorder
- Must be able to attend a follow-up after 18 months after initial visit
Exclusion Criteria:
- Diagnosed with Autism Spectrum Disorder (ASD)
- Diagnosed with Schizophrenia, Conduct Disorder, and/or Bipolar Disorder
- Diagnosed with a genetic disorder
- Premature birth (less than 36 weeks)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adolescents with ADHD
Observational study of behavior cognitive and motor control
|
Observational study of behavior cognitive and motor control
|
|
Adolescents without ADHD
Observational study of behavior cognitive and motor control
|
Observational study of behavior cognitive and motor control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response Control and Frustration Tolerance
Time Frame: Completed on Day 1 or Day 2 Visit
|
Go/No-Go (GNG) reaction time task related to working memory and motivation.
Each task will take place in a single block of 207 trials (80% green), with no rest phases (total duration = 8min, 19 sec).
For the motivational GNG task, stimulus presentation will be followed by a blank screen (1000ms), the presentation of visual feedback (1700ms), and another blank screen (500ms).
Reward feedback will be presented for correct "go" responses and response cost feedback will be presented for commission errors.
|
Completed on Day 1 or Day 2 Visit
|
|
Developmental Trajectory of Brain Anatomy
Time Frame: Completed on Day 1 or Day 2 Visit
|
The Primary outcome variables will be morphometry of cortical regions (thickness, surface area, folding index, volume) and subcortical regions (basal ganglia, amygdala, and hippocampus volume and shape).
|
Completed on Day 1 or Day 2 Visit
|
|
Predictors of Adolescent Socio-Emotional Development
Time Frame: Completed on Day 1 or Day 2 Visit
|
Behavior Assessment System for Children (BASC-3) is a questionnaire used to assess behavioral and emotional functioning in children.
The parent-report, teacher-report, and self-report versions will be administered to collect behavioral and emotional values.
|
Completed on Day 1 or Day 2 Visit
|
|
Developments of ADHD Symptoms
Time Frame: Completed on Day 1 or Day 2 Visit
|
Conners-4 is a questionnaire to values on conduct and learning problems, impulsivity-hyperactivity, anxiety, and social competence.
Parent-report and teacher-report will be administered collect values to determine ADHD symptom severity.
|
Completed on Day 1 or Day 2 Visit
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stewart Mostofsky, Ph.D, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00064633 (Other Identifier: Johns Hopkins Hospital)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 ADHD
-
St. Antonius HospitalNot yet recruitingADHD | Attention Deficit Disorder with Hyperactivity | Attention Deficit Disorder | ADD | ADHD Predominantly Inattentive Type | ADHD, Predominantly Hyperactive - Impulsive | Attention Deficit Disorder (ADD) | Hyperactivity | Inattention | ADHD Predominantly Hyperactivity Type | ADHD-not Other Specified | Hyperactivity... and other conditions
-
Wuhan Sports UniversityTerminatedADHD | ADHD - Combined Type | ADHD - Inattentive Type | ADHD - Attention Deficit Disorder With Hyperactivity | ADHD Specifically With Executive Function ImpairmentChina
-
The Hong Kong Polytechnic UniversityRecruiting
-
Loewenstein HospitalWingate InstituteRecruiting
-
Region Örebro CountyActive, not recruiting
-
University of TorontoCompleted
-
Massachusetts General HospitalCenter for Survey Research, University of Massachusetts, BostonCompleted
-
Akili Interactive Labs, Inc.Active, not recruiting
-
L'hôpital Nord-Ouest - Villefranche Villefranche...Completed
-
Johns Hopkins UniversityWithdrawn
Clinical Trials on Other
-
University of MinnesotaCompleted
-
University of SalamancaNot yet recruitingExercise | First Episode Psychosis (FEP) | Telomere Length
-
University Hospital Center of MartiniqueDepartment for Research, Studies, Evaluation and Statistics, French Health... and other collaboratorsRecruitingMental Disorders | Suicide | Prognostic FactorsMartinique
-
Yuehui YinEnrolling by invitationAtrial FibrillationChina
-
University of Texas Southwestern Medical CenterNational Institute of Mental Health (NIMH)Active, not recruitingSchizophrenia | Cognitive Dysfunction | Aging | Neuroimaging | Biomarker | Disease CourseUnited States
-
Ohio State University Comprehensive Cancer CenterNational Heart, Lung, and Blood Institute (NHLBI); Food and Drug Administration...Completed
-
Xinqiao Hospital of ChongqingCompleted
-
Xinqiao Hospital of ChongqingCompleted
-
China Medical University HospitalChina Medical University, TaiwanUnknownKidney Disease | Autoimmune Rheumatologic Disease | Endocrine, Metabolic or Nutritional Diseases or ConditionsTaiwan