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.

Study Overview

• Status: Completed
• Conditions: ADHD; Neurodevelopmental Disorders; Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Organizational Skills Training; Behavioral: Waitlist

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuliya Yoncheva; Phone Number: 646-754-5147; Email: yuliya.yoncheva@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Waitlist	Behavioral: Waitlist; Will undergo two magnetic resonance imaging (MRI) sessions separated by a 12 week wait period. Will then undergo OST treatment
Experimental: OST Intervention	Behavioral: Organizational Skills Training; Will 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. T-scores can range between 40 and 90	Day 1

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Francisco Castellanos, MD, New York Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders
• Other Study ID Numbers: s17-00263; R61MH113663 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be provided to the NIMH Data Archive (NDA) for sharing to investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No