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

NCT ID: NCT05927506

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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

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ADHD Attention Deficit Hyperactivity Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Adolescents with ADHD

Observational study of behavior cognitive and motor control

Other

Intervention Type BEHAVIORAL

Observational study of behavior cognitive and motor control

Adolescents without ADHD

Observational study of behavior cognitive and motor control

Other

Intervention Type BEHAVIORAL

Observational study of behavior cognitive and motor control

Interventions

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Other

Observational study of behavior cognitive and motor control

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stewart Mostofsky, Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Kennedy Krieger Insititute

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00064633

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00064633

Identifier Type: -

Identifier Source: org_study_id

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