ADHDNCT05927506
Adolescent Changes in Brain and Behavior in Boys and Girls With ADHD
An observational study of ADHD and Attention Deficit Hyperactivity Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Other
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 30 Jun 2023
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- Diagnosed with or without Attention Deficit Hyperactivity Disorder
- Must be able to attend a follow-up after 18 months after initial visit
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Insititute
Baltimore, Maryland, 21205
About this study
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.
Read the 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.
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder
- Being tested
- Other
- Keywords
- Cognitive Testing, Typically Developing, Motor Control, Gender Differences
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherBehavioural
Observational study of behavior cognitive and motor control
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with ADHD | Observational study of behavior cognitive and motor control Receives: Behavioral: Other | |
| Adolescents without ADHD | Observational study of behavior cognitive and motor control Receives: Behavioral: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Control and Frustration Tolerance
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.
Measured: Completed on Day 1 or Day 2 Visit
Developmental Trajectory of Brain Anatomy
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).
Measured: Completed on Day 1 or Day 2 Visit
Predictors of Adolescent Socio-Emotional Development
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.
Measured: Completed on Day 1 or Day 2 Visit
Developments of ADHD Symptoms
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.
Measured: Completed on Day 1 or Day 2 Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jul 2015
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Stewart Mostofsky, Ph.D, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927506
- Sponsor's protocol ID
- IRB00064633
- Other IDs
- IRB00064633
- Status last verified
- Aug 2025
- First submitted
- 21 Mar 2023
- Last updated
- 20 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Changes in Brain and Behavior in Boys and Girls With ADHD
- ClinicalTrials.gov ID
- NCT05927506
- Acronym / sponsor ID
- IRB00064633
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder
- Keywords
- Cognitive Testing, Typically Developing, Motor Control, Gender Differences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 Jul 2023 (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 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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents with ADHD | – | Behavioral: OtherObservational study of behavior cognitive and motor control |
| Adolescents without ADHD | – | Behavioral: OtherObservational study of behavior cognitive and motor control |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- Diagnosed with or without Attention Deficit Hyperactivity Disorder
- Must be able to attend a follow-up after 18 months after initial visit
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| OtherObservational study of behavior cognitive and motor control | Behavioural | Adolescents with ADHD, Adolescents without ADHD |
Primary outcome
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.
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).
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.
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.
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 20 Aug 2025.
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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.
Stewart Mostofsky, Ph.D principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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 ADHD and Attention Deficit Hyperactivity Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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 4 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 20 Aug 2025. 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?
Response Control and Frustration Tolerance (time frame: Completed on Day 1 or Day 2 Visit). The study lists 4 primary outcomes in all. 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 20 Aug 2025.