Completed

NCT Number: NCT04108273

Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

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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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
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)

Treatment and study plan

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Sep 30, 2019
Registry last updated: Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed