Attention Deficit Hyperactivity Disorder (ADHD)NCT06810180
Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Heterogeneity in ADHD
A study testing Go/No-Go Task, Delay discounting task and Mirror Tracing Persistence Task in people with Attention Deficit Hyperactivity Disorder (ADHD) and Sleep, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD), Sleep, Physical Activity
- What is being tested?
- Go/No-Go Task, Delay discounting task and Mirror Tracing Persistence Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2025to 31 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- 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
- Prematurity Prenatal exposure to alcohol or other substances Traumatic brain injury Currently taking medications that cannot be discontinued the day before research appointments
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hugo W. Moser Research Institute at Kennedy Krieger
Baltimore, Maryland, 21205
Christine Collins, 667-205-4226, KKI.researchadmin@kennedykrieger.org
Keri S Rosch, PhD in Clinical Psychology
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Research Coordinator, 443-923-9258, CNIR@kennedykrieger.org
About this study
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.
Read more
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.
- Being tested
- Go/No-Go Task, Delay discounting task, Mirror Tracing Persistence Task, Spatial Span, Stop Signal Task
- Keywords
- ADHD, Circadian Rhythms, Ecological Momentary Assessment (EMA)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go/No-Go TaskBehavioural
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 taskBehavioural
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 TaskBehavioural
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 SpanBehavioural
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 TaskBehavioural
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 taskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group | Experimental | Not described Receives: Behavioral: Go/No-Go Task; Behavioral: Delay discounting task; Behavioral: Mirror Tracing Persistence Task; Behavioral: Spatial Span; Behavioral: Stop Signal Task; Behavioral: Flanker task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Activity Counts (TAC)
Using an actigraph, this study will collect daily physical activity levels of children. The actigraphic measure, total activity counts (TAC), will capture the number of times a child engages in periods of physical activity during the day and night.
Measured: Two-week, real-time period of at-home activity monitoring
Children's Sleep Health Questionnaire (CSHQ) Total Score
Sleep quality will be measured using the total score from the parent reported questionnaire asking about sleep duration, sleep disturbances, and sleep quality.
Measured: Within six months prior to the first research appointment.
ADHD-related Symptoms
Parents will complete a diagnostic interview and rating scales reporting on ADHD symptoms, cognitive disengagement syndrome, irritability and emotion dysregulation.
Measured: Within six months prior to the first research appointment.
Mean Fractional Anisotropy (FA)
Mean fractional anisotropy (FA) is a structural connectivity diffusion weighted imaging outcomes. It is a value that represents the overall degree of directional diffusion within that area, with higher values indicating more organized/connectivity, aligned white matter fibers, and lower values suggesting less organized fibers.
Mean fractional anisotropy (FA) will be assessed in six fronto-subcortical tracts of interest including (1) OFC-limbic striatum, (2) dlPFC-executive striatum, (3) ACC-limbic striatum, (4) ACC-executive striatum, (5) OFC- and (6) ACC-amygdala in each hemisphere.
Measured: Completed during the MRI scan on Day 15
Stop Signal Reaction Time
Measure of inhibitory control from the stop signal task based on the mean stop signal delay and mean go reaction time.
Measured: Task will be completed on Day 15
Congruency Effect on Reaction Time
Difference in reaction time on correct response trials from the flanker task with congruent versus incongruent flanking stimuli.
Measured: Task will be completed on Day 15
Commission Errors
Percentage of incorrect responses on no-go trials during the go/no-go task.
Measured: Task will be completed on Day 15
Backward Span Accuracy
Total number of correct trials for the digit and spatial span tasks (separately), backwards span condition
Measured: Task will be completed on Day 15
Delay Discounting Area Over the Curve (AOC)
Area over the curve (AOC) is a measure of the extent to which an individual discounts a reward as a function of delay. We will assess this measure during delay discounting tasks with different types of rewards (money and game time).
Measured: Task will be completed on Day 15
Mirror Tracing Persistance Task Latency to Quit
During the very hard star condition of the MTPT, participants may choose to quit the task. This is the amount of time that passes until they quit the task.
Measured: Task will be completed on Day 15
Total Sleep Time (TST)
Total sleep time (TST) will be collected using a wearable actigraph wristband. This variable is reported in minutes.
Measured: Two-week, real-time period of at-home activity monitoring
Wake After Sleep Onset (WASO)
This variable is collected using a wearable actigraph wristband. This variable is reported in minutes.
Measured: Two-week, real-time period of at-home activity monitoring
Sleep Efficiency
This variable is collected using a wearable actigraph wristband. This variable is the proportion of time-in-bed spent asleep compared to the total time spent in bed.
Measured: Two-week, real-time period of at-home activity monitoring
Sleep Onset Latency (SOL)
This variable is collected using a wearable actigraph wristband. This variable captures how long it takes for a child to fall asleep once they are in bed.
Measured: Two-week, real-time period of at-home activity monitoring
Intra-daily Variability
This variable is collected using a wearable actigraph wristband. Intra-daily variability is a measure of how fragmented a person's rest-activity rhythm (RAR) is over the course of a 24-hour period. quantifies the amount of switching between high and low activity levels within a day. Higher IV values indicate greater fragmentation, which can be a sign of frequent napping or inefficient sleep.
Measured: Two-week, real-time period of at-home activity monitoring
Midline Estimating Statistic of Rhythm (MESOR)
This variable is collected using a wearable actigraph wristband. Mesor is a rhythm-adjusted mean that describes the value around which a fitted wave oscillates. The wave is dictated by the intensity of physical activity over a 24-hour period.
Measured: Two-week, real-time period of at-home activity monitoring
Functional connectivity Z-scores
Functional connectivity will be examined among the same 6 fronto-subcortical tracts of interest including (1) OFC-limbic striatum, (2) dlPFC-executive striatum, (3) ACC-limbic striatum, (4) ACC-executive striatum, (5) OFC- and (6) ACC-amygdala in each hemisphere, as well as within- and between-network connectivity of the default mode network with the frontoparietal, salience, and affective networks. The primary measure of functional connectivity will be derived by correlating the average time series across ROIs and converting the correlations to z scores using Fisher's transform.
Measured: Completed during an MRI scan on Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start17 Jun 2025
- Primary completion30 Apr 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Keri Rosch, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810180
- Sponsor's protocol ID
- IRB00478295
- Status last verified
- Mar 2026
- First submitted
- 9 Dec 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data collected through questionnaires, computer-tasks, and neuroimaging will be shared with the NIH National Data Archive in compliance with the current data sharing policies. De-identified participant-level data may include the summary metrics produced or extracted from the instruments used in this study.
Publications
Sibley MH, Arnold LE, Swanson JM, Hechtman LT, Kennedy TM, Owens E, Molina BSG, Jensen PS, Hinshaw SP, Roy A, Chronis-Tuscano A, Newcorn JH, Rohde LA; MTA Cooperative Group. Variable Patterns of Remission From ADHD in the Multimodal Treatment Study of ADHD. Am J Psychiatry. 2022 Feb;179(2):142-151. doi: 10.1176/appi.ajp.2021.21010032. Epub 2021 Aug 13.
PubMed 34384227Mordre M, Groholt B, Kjelsberg E, Sandstad B, Myhre AM. The impact of ADHD and conduct disorder in childhood on adult delinquency: a 30 years follow-up study using official crime records. BMC Psychiatry. 2011 Apr 11;11:57. doi: 10.1186/1471-244X-11-57.
PubMed 21481227Fredriksen M, Dahl AA, Martinsen EW, Klungsoyr O, Faraone SV, Peleikis DE. Childhood and persistent ADHD symptoms associated with educational failure and long-term occupational disability in adult ADHD. Atten Defic Hyperact Disord. 2014 Jun;6(2):87-99. doi: 10.1007/s12402-014-0126-1. Epub 2014 Feb 5.
PubMed 24497125Faraone SV, Banaschewski T, Coghill D, Zheng Y, Biederman J, Bellgrove MA, Newcorn JH, Gignac M, Al Saud NM, Manor I, Rohde LA, Yang L, Cortese S, Almagor D, Stein MA, Albatti TH, Aljoudi HF, Alqahtani MMJ, Asherson P, Atwoli L, Bolte S, Buitelaar JK, Crunelle CL, Daley D, Dalsgaard S, Dopfner M, Espinet S, Fitzgerald M, Franke B, Gerlach M, Haavik J, Hartman CA, Hartung CM, Hinshaw SP, Hoekstra PJ, Hollis C, Kollins SH, Sandra Kooij JJ, Kuntsi J, Larsson H, Li T, Liu J, Merzon E, Mattingly G, Mattos P, McCarthy S, Mikami AY, Molina BSG, Nigg JT, Purper-Ouakil D, Omigbodun OO, Polanczyk GV, Pollak Y, Poulton AS, Rajkumar RP, Reding A, Reif A, Rubia K, Rucklidge J, Romanos M, Ramos-Quiroga JA, Schellekens A, Scheres A, Schoeman R, Schweitzer JB, Shah H, Solanto MV, Sonuga-Barke E, Soutullo C, Steinhausen HC, Swanson JM, Thapar A, Tripp G, van de Glind G, van den Brink W, Van der Oord S, Venter A, Vitiello B, Walitza S, Wang Y. The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder. Neurosci Biobehav Rev. 2021 Sep;128:789-818. doi: 10.1016/j.neubiorev.2021.01.022. Epub 2021 Feb 4.
PubMed 33549739Hvolby A. Associations of sleep disturbance with ADHD: implications for treatment. Atten Defic Hyperact Disord. 2015 Mar;7(1):1-18. doi: 10.1007/s12402-014-0151-0. Epub 2014 Aug 17.
PubMed 25127644Buitelaar J, Bolte S, Brandeis D, Caye A, Christmann N, Cortese S, Coghill D, Faraone SV, Franke B, Gleitz M, Greven CU, Kooij S, Leffa DT, Rommelse N, Newcorn JH, Polanczyk GV, Rohde LA, Simonoff E, Stein M, Vitiello B, Yazgan Y, Roesler M, Doepfner M, Banaschewski T. Toward Precision Medicine in ADHD. Front Behav Neurosci. 2022 Jul 6;16:900981. doi: 10.3389/fnbeh.2022.900981. eCollection 2022.
PubMed 35874653
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Heterogeneity in ADHD
- ClinicalTrials.gov ID
- NCT06810180
- Acronym / sponsor ID
- IRB00478295
- Keywords
- ADHD, Circadian Rhythms, Ecological Momentary Assessment (EMA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | Experimental | Behavioral: Go/No-Go Task, Behavioral: Delay discounting task, Behavioral: Mirror Tracing Persistence Task, Behavioral: Spatial Span, Behavioral: Stop Signal Task, Behavioral: Flanker task |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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
- Prematurity Prenatal exposure to alcohol or other substances Traumatic brain injury Currently taking medications that cannot be discontinued the day before research appointments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Go/No-Go TaskA 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). | Behavioural | Group |
| Delay discounting taskParticipants 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. | Behavioural | Group |
| Mirror Tracing Persistence TaskA 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. | Behavioural | Group |
| Spatial SpanParticipants 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. | Behavioural | Group |
| Stop Signal TaskA 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. | Behavioural | Group |
| Flanker taskA 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. | Behavioural | Group |
Primary outcome
Total Activity Counts (TAC)
Time frame: Two-week, real-time period of at-home activity monitoring
Using an actigraph, this study will collect daily physical activity levels of children. The actigraphic measure, total activity counts (TAC), will capture the number of times a child engages in periods of physical activity during the day and night.
Children's Sleep Health Questionnaire (CSHQ) Total Score
Time frame: Within six months prior to the first research appointment.
Sleep quality will be measured using the total score from the parent reported questionnaire asking about sleep duration, sleep disturbances, and sleep quality.
ADHD-related Symptoms
Time frame: Within six months prior to the first research appointment.
Parents will complete a diagnostic interview and rating scales reporting on ADHD symptoms, cognitive disengagement syndrome, irritability and emotion dysregulation.
Mean Fractional Anisotropy (FA)
Time frame: Completed during the MRI scan on Day 15
Mean fractional anisotropy (FA) is a structural connectivity diffusion weighted imaging outcomes. It is a value that represents the overall degree of directional diffusion within that area, with higher values indicating more organized/connectivity, aligned white matter fibers, and lower values suggesting less organized fibers. Mean fractional anisotropy (FA) will be assessed in six fronto-subcortical tracts of interest including (1) OFC-limbic striatum, (2) dlPFC-executive striatum, (3) ACC-limbic striatum, (4) ACC-executive striatum, (5) OFC- and (6) ACC-amygdala in each hemisphere.
Stop Signal Reaction Time
Time frame: Task will be completed on Day 15
Measure of inhibitory control from the stop signal task based on the mean stop signal delay and mean go reaction time.
Congruency Effect on Reaction Time
Time frame: Task will be completed on Day 15
Difference in reaction time on correct response trials from the flanker task with congruent versus incongruent flanking stimuli.
Commission Errors
Time frame: Task will be completed on Day 15
Percentage of incorrect responses on no-go trials during the go/no-go task.
Backward Span Accuracy
Time frame: Task will be completed on Day 15
Total number of correct trials for the digit and spatial span tasks (separately), backwards span condition
Delay Discounting Area Over the Curve (AOC)
Time frame: Task will be completed on Day 15
Area over the curve (AOC) is a measure of the extent to which an individual discounts a reward as a function of delay. We will assess this measure during delay discounting tasks with different types of rewards (money and game time).
Mirror Tracing Persistance Task Latency to Quit
Time frame: Task will be completed on Day 15
During the very hard star condition of the MTPT, participants may choose to quit the task. This is the amount of time that passes until they quit the task.
Total Sleep Time (TST)
Time frame: Two-week, real-time period of at-home activity monitoring
Total sleep time (TST) will be collected using a wearable actigraph wristband. This variable is reported in minutes.
Wake After Sleep Onset (WASO)
Time frame: Two-week, real-time period of at-home activity monitoring
This variable is collected using a wearable actigraph wristband. This variable is reported in minutes.
Sleep Efficiency
Time frame: Two-week, real-time period of at-home activity monitoring
This variable is collected using a wearable actigraph wristband. This variable is the proportion of time-in-bed spent asleep compared to the total time spent in bed.
Sleep Onset Latency (SOL)
Time frame: Two-week, real-time period of at-home activity monitoring
This variable is collected using a wearable actigraph wristband. This variable captures how long it takes for a child to fall asleep once they are in bed.
Intra-daily Variability
Time frame: Two-week, real-time period of at-home activity monitoring
This variable is collected using a wearable actigraph wristband. Intra-daily variability is a measure of how fragmented a person's rest-activity rhythm (RAR) is over the course of a 24-hour period. quantifies the amount of switching between high and low activity levels within a day. Higher IV values indicate greater fragmentation, which can be a sign of frequent napping or inefficient sleep.
Midline Estimating Statistic of Rhythm (MESOR)
Time frame: Two-week, real-time period of at-home activity monitoring
This variable is collected using a wearable actigraph wristband. Mesor is a rhythm-adjusted mean that describes the value around which a fitted wave oscillates. The wave is dictated by the intensity of physical activity over a 24-hour period.
Functional connectivity Z-scores
Time frame: Completed during an MRI scan on Day 15
Functional connectivity will be examined among the same 6 fronto-subcortical tracts of interest including (1) OFC-limbic striatum, (2) dlPFC-executive striatum, (3) ACC-limbic striatum, (4) ACC-executive striatum, (5) OFC- and (6) ACC-amygdala in each hemisphere, as well as within- and between-network connectivity of the default mode network with the frontoparietal, salience, and affective networks. The primary measure of functional connectivity will be derived by correlating the average time series across ROIs and converting the correlations to z scores using Fisher's transform.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 34384227Sibley MH, Arnold LE, Swanson JM, Hechtman LT, Kennedy TM, Owens E, Molina BSG, Jensen PS, Hinshaw SP, Roy A, Chronis-Tuscano A, Newcorn JH, Rohde LA; MTA Cooperative Group. Variable Patterns of Remission From ADHD in the Multimodal Treatment Study of ADHD. Am J Psychiatry. 2022 Feb;179(2):142-151. doi: 10.1176/appi.ajp.2021.21010032. Epub 2021 Aug 13.
- Background: PubMed 21481227Mordre M, Groholt B, Kjelsberg E, Sandstad B, Myhre AM. The impact of ADHD and conduct disorder in childhood on adult delinquency: a 30 years follow-up study using official crime records. BMC Psychiatry. 2011 Apr 11;11:57. doi: 10.1186/1471-244X-11-57.
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- Individual participant dataSharing planned: Yes. De-identified participant-level data collected through questionnaires, computer-tasks, and neuroimaging will be shared with the NIH National Data Archive in compliance with the current data sharing policies. De-identified participant-level data may include the summary metrics produced or extracted from the instruments used in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go/No-Go Task, Delay discounting task and Mirror Tracing Persistence Task in people with Attention Deficit Hyperactivity Disorder (ADHD) and Sleep, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keri S Rosch, PhD in Clinical Psychology (443-923-9465, Rosch@KennedyKrieger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Activity Counts (TAC) (time frame: Two-week, real-time period of at-home activity monitoring). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06810180, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.