Adolescent Changes in Brain and Behavior in Boys and Girls With ADHD

The purpose of the study is to examine the developmental trajectory of response control in boys and girls with ADHD entering adolescence. The investigators also want to determine the developmental trajectory of brain anatomy and brain connectivity in boys and girls with ADHD entering adolescence.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Kennedy Krieger Insititute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Male and Female adolescents within the age range of 12-17 years old, with or without a diagnosis of Attention Deficit Hyperactivity Disorder

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Stewart Mostofsky, Ph.D, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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