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Completed

NCT Number: NCT05927506

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kennedy Krieger Insititute

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Other

Behavioral

Observational study of behavior cognitive and motor control

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Other

Collaborators

  • Johns Hopkins University

Registry information

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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