ADHDNCT04108273

Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

A study testing Organizational Skills Training in people with ADHD and Attention Deficit Hyperactivity Disorder, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 8 to 12 years
Conditions the study is for: ADHD, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders
What is being tested?: Organizational Skills Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2019to 1 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Child

Who may be able to join

Age at entry: age ≥ 8.0 and ≤ 11.9 years corresponding to grades 3-5
Written assent by child and consent by parent or legal guardian
IQ: Estimated full scale IQ ≥ 85 and language comprehension scores ≥ 8
Organizational skills deficits defined as elevated (≥ 1SD) pre-treatment Children's Organizational Skills Scales (COSS) Parent Total T-score and at least one COSS Parent Interference item rated as either a 3 or 4 (indicating an above-average level of impairment)
Must provide adequate MRI data at baseline

Who cannot join

Enrolled in a self-contained special education classroom or served by a 1:1 paraprofessional in their classroom
Absence of signed consent by parent or legal guardian
Children who dissent regardless of parental permission
Full scale IQ < 85
Children with a recent (past 6 months) or current history of neuroleptic treatment or current treatment with psychotropic medications other than stimulants
Per history (and medical records if needed) medical illness requiring chronic current treatment

Show all 11Show fewer

History of intrathecal chemotherapy or focal cranial irradiation
Premature birth (< 32 weeks estimated gestational age or birth weight < 1500g)
History of leukomalacia or static encephalopathy, intracerebral hemorrhage beyond grade 2, other specific or focal neurological or metabolic disorder including epilepsy (except for resolved febrile seizures)
History of traumatic brain injury
Contraindication for MRI scanning (metal implants, pacemakers, metal foreign bodies or pregnancy)

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Health
New York, New York, 10016

Other trials in United States

About this study

Organizational, time management and planning (OTMP) skills deficits are impairing features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD), which compromise school performance and family relations. The manualized Organizational Skills Training program (OST) was designed to target children's specific OTMP deficits. However, the brain mechanisms of treatment-induced changes remain unknown. The current study combines a training intervention (OST) with non-invasive MRI imaging in a pre-/post-design in a randomized two-arm (treatment vs. waitlist) trial to address this question.

Conditions: ADHD, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders
Being tested: Organizational Skills Training
Medical subject headings: Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Organizational Skills TrainingBehavioural
OST targets three core organizational skills domains - Tracking Assignments, Managing Materials and Time Management - in a program consisting of sessions over 12 weeks, each training lasting about 1 hour, and corresponding 30-60 minute weekly review sessions with the parent and the child, 2-3 days following each training session.

Study groups in NCT04108273
Study group	Role	What they receive
No-Wait	Experimental	Participants with organizational skill difficulties to undergo two magnetic resonance imaging (MRI) sessions: one within 2 weeks prior to OST treatment and one within 2 weeks of completion of the OST treatment. Receives: Behavioral: Organizational Skills Training
Waitlist	Active comparator	Participants with organizational skill difficulties to undergo two magnetic resonance imaging (MRI) sessions: one 12 weeks prior to OST treatment and one ~12 weeks after their first scan and before proceeding to OST. Receives: Behavioral: Organizational Skills Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Default Mode Network Subdivision of the Anterior Ventral Striatum (aVS-DMN)
The iFC between the two regions was measured at both baseline and follow-up by calculating the Fisher Z-transformed correlation between the average time-series of all voxels within each region of interest (positive values indicate increased iFC between the two regions, while negative values indicate decreased iFC). Then, to determine the change in iFC due to the intervention/waitlist period, the iFC between both regions at baseline was subtracted from the iFC between both regions at follow-up. Therefore, this provides a measure of the change in iFC due to the intervention or waitlist period, with positive values indicating an increase in iFC and negative values indicating a decrease in iFC due to the intervention/waitlist period.
Measured: baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks)
Change in Parent Children's Organizational Skills Scales (COSS-P) Total T-scores Following OST Intervention
The Children's Organizational Skills Scale quantifies how children (ages 8-13) organize their time, materials, and actions to accomplish important tasks at home and school. The Parent report consists of 66 questions, each using a 4-point Likert-type scale (where 1=Hardly ever or never and 4=just about all the time). Scores are normalized to a T-distribution, with a population mean of 50; scores of 60 or above are considered evidence of deficient organizational skills.
Measured: baseline, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks)
Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Fronto Parietal Network Subdivision of the Anterior Ventral Striatum (aVS-FP)
The iFC between the two regions was measured at both baseline and follow-up by calculating the Fisher Z-transformed correlation between the average time-series of all voxels within each region of interest (positive values indicate increased iFC between the two regions, while negative values indicate decreased iFC). Then, to determine the change in iFC due to the intervention/waitlist period, the iFC between both regions at baseline was subtracted from the iFC between both regions at follow-up. Therefore, this provides a measure of the change in iFC due to the intervention or waitlist period, with positive values indicating an increase in iFC and negative values indicating a decrease in iFC due to the intervention/waitlist period.
Measured: baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks)
Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Limbic Network Subdivision of the Anterior Ventral Striatum (aVS-LIM)
The iFC between the two regions was measured at both baseline and follow-up by calculating the Fisher Z-transformed correlation between the average time-series of all voxels within each region of interest (positive values indicate increased iFC between the two regions, while negative values indicate decreased iFC). Then, to determine the change in iFC due to the intervention/waitlist period, the iFC between both regions at baseline was subtracted from the iFC between both regions at follow-up. Therefore, this provides a measure of the change in iFC due to the intervention or waitlist period, with positive values indicating an increase in iFC and negative values indicating a decrease in iFC due to the intervention/waitlist period.
Measured: baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20191 Aug 2023

First posted30 Sep 2019
Study start1 Oct 2019
Primary completion20 Jun 2023
Study completion1 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ADHDStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04108273
Sponsor's protocol ID: s17-00263
Other IDs: R61MH113663
Status last verified: Jul 2024
First submitted: 26 Sep 2019
Last updated: 1 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data will be provided to the NIMH Data Archive (NDA) for sharing to investigators

Publications

Martinez Agulleiro L, Deng B, Gallagher R, Abikoff HB, Yoncheva Y, Robinson L, Conlon G, Haroon M, Yan CG, Di Martino A, Zhao Y, Castellanos FX. Brain plasticity underlying acquisition of new organizational skills in children: A Rashomon analysis. Front Neuroimaging. 2025 Dec 9;4:1671310. doi: 10.3389/fnimg.2025.1671310. eCollection 2025.
PubMed 41446359

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ADHD trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
ClinicalTrials.gov ID: NCT04108273
Acronym / sponsor ID: s17-00263
Conditions: ADHD, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Oct 2019 (actual)
Primary completion: 20 Jun 2023 (actual)
Study completion: 1 Aug 2023 (actual)
First posted: 30 Sep 2019 (actual)
Results: Posted 1 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
No-Wait	Experimental	Behavioral: Organizational Skills TrainingParticipants with organizational skill difficulties to undergo two magnetic resonance imaging (MRI) sessions: one within 2 weeks prior to OST treatment and one within 2 weeks of completion of the OST treatment.
Waitlist	Active comparator	Behavioral: Organizational Skills TrainingParticipants with organizational skill difficulties to undergo two magnetic resonance imaging (MRI) sessions: one 12 weeks prior to OST treatment and one ~12 weeks after their first scan and before proceeding to OST.

Who may qualify

Ages: 8 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Age at entry: age ≥ 8.0 and ≤ 11.9 years corresponding to grades 3-5
Written assent by child and consent by parent or legal guardian
IQ: Estimated full scale IQ ≥ 85 and language comprehension scores ≥ 8
Organizational skills deficits defined as elevated (≥ 1SD) pre-treatment Children's Organizational Skills Scales (COSS) Parent Total T-score and at least one COSS Parent Interference item rated as either a 3 or 4 (indicating an above-average level of impairment)
Must provide adequate MRI data at baseline

Key exclusion criteria (11 listed)

Enrolled in a self-contained special education classroom or served by a 1:1 paraprofessional in their classroom
Absence of signed consent by parent or legal guardian
Children who dissent regardless of parental permission
Full scale IQ < 85
Children with a recent (past 6 months) or current history of neuroleptic treatment or current treatment with psychotropic medications other than stimulants

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
Organizational Skills TrainingOST targets three core organizational skills domains - Tracking Assignments, Managing Materials and Time Management - in a program consisting of sessions over 12 weeks, each training lasting about 1 hour, and corresponding 30-60 minute weekly review sessions with the parent and the child, 2-3 days following each training session.	Behavioural	No-Wait, Waitlist

Primary outcome

Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Default Mode Network Subdivision of the Anterior Ventral Striatum (aVS-DMN)
Time frame: baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks)
The iFC between the two regions was measured at both baseline and follow-up by calculating the Fisher Z-transformed correlation between the average time-series of all voxels within each region of interest (positive values indicate increased iFC between the two regions, while negative values indicate decreased iFC). Then, to determine the change in iFC due to the intervention/waitlist period, the iFC between both regions at baseline was subtracted from the iFC between both regions at follow-up. Therefore, this provides a measure of the change in iFC due to the intervention or waitlist period, with positive values indicating an increase in iFC and negative values indicating a decrease in iFC due to the intervention/waitlist period.
Change in Parent Children's Organizational Skills Scales (COSS-P) Total T-scores Following OST Intervention
Time frame: baseline, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks)
The Children's Organizational Skills Scale quantifies how children (ages 8-13) organize their time, materials, and actions to accomplish important tasks at home and school. The Parent report consists of 66 questions, each using a 4-point Likert-type scale (where 1=Hardly ever or never and 4=just about all the time). Scores are normalized to a T-distribution, with a population mean of 50; scores of 60 or above are considered evidence of deficient organizational skills.
Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Fronto Parietal Network Subdivision of the Anterior Ventral Striatum (aVS-FP)
Time frame: baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks)
The iFC between the two regions was measured at both baseline and follow-up by calculating the Fisher Z-transformed correlation between the average time-series of all voxels within each region of interest (positive values indicate increased iFC between the two regions, while negative values indicate decreased iFC). Then, to determine the change in iFC due to the intervention/waitlist period, the iFC between both regions at baseline was subtracted from the iFC between both regions at follow-up. Therefore, this provides a measure of the change in iFC due to the intervention or waitlist period, with positive values indicating an increase in iFC and negative values indicating a decrease in iFC due to the intervention/waitlist period.
Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Limbic Network Subdivision of the Anterior Ventral Striatum (aVS-LIM)
Time frame: baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks)
The iFC between the two regions was measured at both baseline and follow-up by calculating the Fisher Z-transformed correlation between the average time-series of all voxels within each region of interest (positive values indicate increased iFC between the two regions, while negative values indicate decreased iFC). Then, to determine the change in iFC due to the intervention/waitlist period, the iFC between both regions at baseline was subtracted from the iFC between both regions at follow-up. Therefore, this provides a measure of the change in iFC due to the intervention or waitlist period, with positive values indicating an increase in iFC and negative values indicating a decrease in iFC due to the intervention/waitlist period.

Results and safety

Results posted to the registry on 1 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No-Wait	30	29
Waitlist	29	29

Primary outcome: Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Default Mode Network Subdivision of the Anterior Ventral Striatum (aVS-DMN)

Time frame: baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks). Mean (Standard Deviation). Unit: Fisher transformed z values

Measure	No-Wait n = 25	Waitlist n = 26
Value	-0.07 (0.214)	0.01 (0.196)

Primary outcome: Change in Parent Children's Organizational Skills Scales (COSS-P) Total T-scores Following OST Intervention

Time frame: baseline, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks). Mean (Standard Deviation). Unit: scores on a scale

Measure	No-Wait n = 26	Waitlist n = 26
Value	-14.8 (7.61)	-3.5 (5.87)

Primary outcome: Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Fronto Parietal Network Subdivision of the Anterior Ventral Striatum (aVS-FP)

Time frame: baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks). Mean (Standard Deviation). Unit: Fisher transformed z values

Measure	No-Wait n = 25	Waitlist n = 26
Value	-0.13 (0.213)	-0.1 (0.182)

Primary outcome: Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Limbic Network Subdivision of the Anterior Ventral Striatum (aVS-LIM)

Time frame: baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks). Mean (Standard Deviation). Unit: Fisher transformed z values

Measure	No-Wait n = 25	Waitlist n = 26
Value	0.003 (0.176)	0.0003 (0.165)

Adverse events

Time frame: Participants in the active arm were assessed during the period they received the intervention (i.e., since baseline until the last visit, up to 14 weeks). Participants in the waitlist arm were not assessed for adverse events.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No-Wait	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Waitlist	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41446359Martinez Agulleiro L, Deng B, Gallagher R, Abikoff HB, Yoncheva Y, Robinson L, Conlon G, Haroon M, Yan CG, Di Martino A, Zhao Y, Castellanos FX. Brain plasticity underlying acquisition of new organizational skills in children: A Rashomon analysis. Front Neuroimaging. 2025 Dec 9;4:1671310. doi: 10.3389/fnimg.2025.1671310. eCollection 2025.
Individual participant dataSharing planned: Yes. De-identified individual participant data will be provided to the NIMH Data Archive (NDA) for sharing to investigators

Related trials for ADHD

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
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Not yet recruitingPhase 2
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RecruitingObservational 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. This study is not recruiting at the moment.

Francisco Castellanos, MD principal investigator

New York Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Organizational Skills Training in people with ADHD and Attention Deficit Hyperactivity Disorder, run by NYU Langone Health at 1 site 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Default Mode Network Subdivision of the Anterior Ventral Striatum (aVS-DMN) (time frame: baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks)). The study lists 4 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 NCT04108273, which also lists 1 linked publication.

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 1 Aug 2024.