Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder; ADHD; Neurodevelopmental Disorders
• Interventions: Behavioral: Organizational Skills Training

• Registration Number: NCT04108273
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Study Start: 2019-10-01
• Primary Completion: 2023-06-20
• Study Completion: 2023-08-01
• Results First Submitted: 2024-06-06
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Results First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No-Wait	Organizational Skills Training	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.
Waitlist	Organizational Skills Training	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.

Primary Outcome Measures

Name	Time	Method
Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Limbic Network Subdivision of the Anterior Ventral Striatum (aVS-LIM)	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	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)	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 Default Mode Network Subdivision of the Anterior Ventral Striatum (aVS-DMN)	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States