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Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

NCT04108273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-08-01

Study results available
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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.

Conditions

  • ADHD
  • Attention Deficit Hyperactivity Disorder
  • Neurodevelopmental Disorders

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Francisco Castellanos, MD · New York Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2023-06-20
Completion
2023-08-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04108273 on ClinicalTrials.gov