Trial Outcomes & Findings for Brain Plasticity Underlying Acquisition of New Organizational Skills in Children (NCT NCT04108273)
NCT ID: NCT04108273
Last Updated: 2024-08-01
Results Overview
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.
COMPLETED
NA
59 participants
baseline MRI, second MRI visit (treatment arm ~14 weeks, waitlist arm ~12 weeks)
2024-08-01
Participant Flow
Participant milestones
| Measure |
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.
|
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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|---|---|---|
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Overall Study
STARTED
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30
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29
|
|
Overall Study
COMPLETED
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29
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29
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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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|---|---|---|
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Overall Study
COVID Pandemic
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1
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0
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Baseline Characteristics
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
Baseline characteristics by cohort
| Measure |
No-Wait
n=29 Participants
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.
|
Waitlist
n=29 Participants
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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Total
n=58 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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9.5 years
STANDARD_DEVIATION 0.949 • n=5 Participants
|
9.4 years
STANDARD_DEVIATION 0.686 • n=7 Participants
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9.5 years
STANDARD_DEVIATION 0.821 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
No-Wait
n=25 Participants
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.
|
Waitlist
n=26 Participants
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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|---|---|---|
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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)
|
-0.07 Fisher transformed z values
Standard Deviation 0.214
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0.01 Fisher transformed z values
Standard Deviation 0.196
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
No-Wait
n=26 Participants
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.
|
Waitlist
n=26 Participants
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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Change in Parent Children's Organizational Skills Scales (COSS-P) Total T-scores Following OST Intervention
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-14.8 scores on a scale
Standard Deviation 7.61
|
-3.5 scores on a scale
Standard Deviation 5.87
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
No-Wait
n=25 Participants
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.
|
Waitlist
n=26 Participants
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.
|
|---|---|---|
|
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)
|
-0.13 Fisher transformed z values
Standard Deviation 0.213
|
-0.1 Fisher transformed z values
Standard Deviation 0.182
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
No-Wait
n=25 Participants
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.
|
Waitlist
n=26 Participants
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.
|
|---|---|---|
|
Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Limbic Network Subdivision of the Anterior Ventral Striatum (aVS-LIM)
|
0.003 Fisher transformed z values
Standard Deviation 0.176
|
0.0003 Fisher transformed z values
Standard Deviation 0.165
|
Adverse Events
No-Wait
Waitlist
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place