NCT05927506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

8 years

First QC Date

March 21, 2023

Last Update Submit

August 15, 2025

Conditions

Keywords

Cognitive TestingTypically DevelopingMotor ControlGender Differences

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Adolescents with ADHD

Observational study of behavior cognitive and motor control

Behavioral: Other

Adolescents without ADHD

Observational study of behavior cognitive and motor control

Behavioral: Other

Interventions

OtherBEHAVIORAL

Observational study of behavior cognitive and motor control

Adolescents with ADHDAdolescents without ADHD

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • Diagnosed with or without Attention Deficit Hyperactivity Disorder
  • Must be able to attend a follow-up after 18 months after initial visit

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Insititute

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Stewart Mostofsky, Ph.D

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2023

First Posted

July 3, 2023

Study Start

July 1, 2015

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 20, 2025

Record last verified: 2025-08

Locations