Clinical trial NCT05927506: Adolescent Changes in Brain and Behavior in Boys and Girls With ADHD
Official title: Adolescent Changes in Brain and Behavior in Boys and Girls With ADHD
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: ADHD
Attention Deficit Hyperactivity Disorder
Keywords: Cognitive Testing
Typically Developing
Motor Control
Gender Differences
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2023-07-03
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Response Control and Frustration Tolerance
timeFrame: Completed on Day 1 or Day 2 Visit
measure: Developmental Trajectory of Brain Anatomy
timeFrame: Completed on Day 1 or Day 2 Visit
measure: Predictors of Adolescent Socio-Emotional Development
timeFrame: Completed on Day 1 or Day 2 Visit
measure: Developments of ADHD Symptoms
timeFrame: Completed on Day 1 or Day 2 Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Insititute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Stewart Mostofsky, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: