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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927506
• Other study ID #: IRB00064633
• Secondary ID: IRB00064633
• Status: Recruiting
• Start date: July 1, 2015
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: Alyssa DeRonda, M.S.
• Email: DeRonda[@]kennedykrieger.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Behavioral:
• Other
Observational study of behavior cognitive and motor control

Locations

Country	Name	City	State
United States	Kennedy Krieger Insititute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Completed on Day 1 or Day 2 Visit
Primary	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).	Completed on Day 1 or Day 2 Visit
Primary	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.	Completed on Day 1 or Day 2 Visit
Primary	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.	Completed on Day 1 or Day 2 Visit