Recruiting

Observational Study

Sponsor:

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

Code:

NCT06810180

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Sleep

Physical Activity

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

Interventions

Go/No-Go Task

Delay discounting task

Mirror Tracing Persistence Task

Spatial Span

Stop Signal Task

Study Details

Brief summary:

Attention deficit/hyperactivity disorder (ADHD) can present differently in individuals, with some individuals having difficulty with attentional control, hyperactivity, impulsivity, emotion dysregulation, and/or neurobehavioral functioning. The factors contributing to these different presentations remain unclear, but altered patterns of physical activity, sleep, and circadian rest/activity rhythms may play a key role.

The goal of this study is to leverage wearable technology (i.e., a wristband) to investigate the relationships between physical activity during the day, sleep patterns and disturbances, and 24-hour circadian rest/activity rhythms with differences in ADHD symptoms, emotion dysregulation, and related brain and behavioral features of attention-deficit/hyperactivity disorder (ADHD). The investigators hope this study will help improve assessment and intervention for individuals with ADHD by understanding how these factors relate to ADHD symptom expression and associated brain differences in ADHD.

Participants taking stimulant medication must withhold stimulant medication 24 hours before their research appointment and the morning of their research appointment. Stimulant medication may be restarted after the appointment is complete.

Participation in this study will require children to complete an initial 2-hour research appointment, two (2) weeks of activity and sleep monitoring at home using a wearable wristband and answering questions sent to a smartphone, and a second 4-hour research appointment after the 2-week period.

During the first research appointment, children will complete a cognitive assessment and a practice magnetic resonance imaging (MRI) scan. Parents/legal guardians will participate in the 30-45-minute sleep device training session with one of the research staff.

During the two weeks of activity/sleep monitoring at home, parents and children will answer questions about their sleep routine, ADHD symptoms, and emotional responding each morning and evening. Parents will be asked to install a questionnaire application on their smartphone. A prompt will be sent to their smartphone multiple times per day reminding parents to complete the brief assessment.

After the 2-week period, children will complete a 4-hour research appointment. During this research appointment, children will complete a 60-minute MRI scan and computer-based activities that assess cognitive skills, reward-based decision-making, and frustration tolerance. At the end of the research appointment, children will return the device to our research team. Parents may delete the questionnaire application from their phone at the end of the research appointment.

Participation will also require parents/legal guardians to complete questionnaires about their child. Questionnaires will be provided to the primary caregiver by email or at the beginning of their child's first research appointment. Parents agree to complete and return the questionnaires within one month of their child's research appointment.

Parents may be provided with additional questionnaires to give to their child's primary schoolteacher. This information is collected to better understand children's abilities, behavior, strengths, and weaknesses.

There are minimal risks associated with this study. Risks include fatigue, boredom, and mild discomfort.

There is no cost to participating in this study.

There is no direct benefit to participants for participating in this study.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Sleep

Physical Activity

Study ID

NCT06810180

Start date

Jun 17, 2025

Status verified date

Mar, 2026

Completion date

Mar 31, 2031

Anticipated

Primary completion date

Apr 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

ADHD Clinical Group. Meet criteria for attention deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria.

Exclusion Criteria:

Prematurity Prenatal exposure to alcohol or other substances Traumatic brain injury Co-occurring neurodevelopmental disorders (e.g., autism spectrum disorder, intellectual disability) Anxiety/mood disorders Active psychosis Bipolar disorder Conduct disorder Currently taking longer acting psychotropic medications that cannot be discontinued the day before research appointments

Control Group. Does not meet criteria for psychological or neuropsychological disorders Does not meet criteria for intellectual disability Does not meet criteria for a learning disorder

Exclusion Criteria:

Prematurity Prenatal exposure to alcohol or other substances Traumatic brain injury Currently taking medications that cannot be discontinued the day before research appointments

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Group

Interventions

Go/No-Go Task

A computerized test in which participants are presented with red and green spaceship stimuli. They are told to press the spacebar in response to green spaceships (80% of trials) and withhold their response to red spaceships (20% of trials).

Delay discounting task

Participants make decisions between smaller, immediate rewards and larger, delayed rewards. The amount of the immediate reward and delay time are manipulated to identify individual delay discounting curves, or how the reward value decreases as a function of delay.

Mirror Tracing Persistence Task

A computerized test in which participants trace a star line drawing with a computer cursor using a trackpad with reversed directional controls. There are increasing levels of difficulty with participants being told they could quit the task during the very hard third star that they try to trace.

Spatial Span

Participants are instructed to attend to a computer screen to keep track of the order in which a happy face stimuli appears in a sequence of boxes positioned on the screen. They are presented with 2 trials at each level of difficulty, increasing from 2 stimuli by 1 additional stimuli per trial until they respond incorrectly for both trials within a level. There are two task conditions, forward and backward span, with the participant responding in the reverse order that the stimuli were presented for backward span.

Stop Signal Task

A computerized test in which participants are presented with a right or left facing arrow and are instructed to press a response button indicating the direction of the arrow. On 25% of the trials, an auditory beep is presented (i.e., stop signal) following the onset of the arrow (i.e., go signal) and participants are instructed to withhold their response when they hear the stop signal.

Flanker task

A computerized test in which a group of arrows are presented on the screen with the central arrow (target) pointing in the same/opposite direction as the 4 surrounding arrows (flankers). Participants are instructed to respond as quickly and accurately as possible to the central target arrow.

Primary outcome measure

  • Total Activity Counts (TAC) [ Time Frame: Two-week, real-time period of at-home activity monitoring ]
  • Children's Sleep Health Questionnaire (CSHQ) Total Score [ Time Frame: Within six months prior to the first research appointment. ]
  • ADHD-related Symptoms [ Time Frame: Within six months prior to the first research appointment. ]
  • Mean Fractional Anisotropy (FA) [ Time Frame: Completed during the MRI scan on Day 15 ]
  • Stop Signal Reaction Time [ Time Frame: Task will be completed on Day 15 ]
  • Congruency Effect on Reaction Time [ Time Frame: Task will be completed on Day 15 ]
  • Commission Errors [ Time Frame: Task will be completed on Day 15 ]
  • Backward Span Accuracy [ Time Frame: Task will be completed on Day 15 ]
  • Delay Discounting Area Over the Curve (AOC) [ Time Frame: Task will be completed on Day 15 ]
  • Mirror Tracing Persistance Task Latency to Quit [ Time Frame: Task will be completed on Day 15 ]
  • Total Sleep Time (TST) [ Time Frame: Two-week, real-time period of at-home activity monitoring ]
  • Wake After Sleep Onset (WASO) [ Time Frame: Two-week, real-time period of at-home activity monitoring ]
  • Sleep Efficiency [ Time Frame: Two-week, real-time period of at-home activity monitoring ]
  • Sleep Onset Latency (SOL) [ Time Frame: Two-week, real-time period of at-home activity monitoring ]
  • Intra-daily Variability [ Time Frame: Two-week, real-time period of at-home activity monitoring ]
  • Midline Estimating Statistic of Rhythm (MESOR) [ Time Frame: Two-week, real-time period of at-home activity monitoring ]
  • Functional connectivity Z-scores [ Time Frame: Completed during an MRI scan on Day 15 ]

Central Contacts and Locations

Central contacts

Keri S Rosch, PhD in Clinical Psychology

443-923-9465Rosch@KennedyKrieger.org

Alyssa C DeRonda, MS in Experimental Psychology

443-923-9258deronda@kennedykrieger.org

Locations

Hugo W. Moser Research Institute at Kennedy Krieger

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Christine Collins

667-205-4226KKI.researchadmin@kennedykrieger.org

Principal Investigator:

Keri S Rosch, PhD in Clinical Psychology

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Research Coordinator

443-923-9258CNIR@kennedykrieger.org

More Information

Sponsor

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

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • ADHD
  • Circadian Rhythms
  • Ecological Momentary Assessment (EMA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. on 2026-03-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.