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| ID | Type | Description | Link |
|---|---|---|---|
| R61MH113663 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Organizational Skills Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Castellanos, MD | New York Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41446359 | Derived | 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. |
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De-identified individual participant data will be provided to the NIMH Data Archive (NDA) for sharing to investigators
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| ID | Title | Description |
|---|---|---|
| FG000 | No-Wait | 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. Organizational Skills Training: 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. |
| FG001 | Waitlist | 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. Organizational Skills Training: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | No-Wait | 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. Organizational Skills Training: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Fisher transformed z values | baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No-Wait | 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. Organizational Skills Training: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francisco Castellanos, MD | NYU Langone Health | 6467545194 | Francisco.Castellanos@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2023 | Jun 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D001523 | Mental Disorders |
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| 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. | baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks) |
| BG001 | Waitlist | 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. Organizational Skills Training: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| No-Wait |
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. Organizational Skills Training: 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. |
| OG001 | Waitlist | 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. Organizational Skills Training: 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. |
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| Primary | 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. | Posted | Mean | Standard Deviation | scores on a scale | baseline, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks) |
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| Primary | 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. | Posted | Mean | Standard Deviation | Fisher transformed z values | baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks) |
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| Primary | 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. | Posted | Mean | Standard Deviation | Fisher transformed z values | baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks) |
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| EG001 | Waitlist | 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. Organizational Skills Training: 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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