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Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

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ClinicalTrials.gov Identifier: NCT04108273
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
ADHD Attention Deficit Hyperactivity Disorder Neurodevelopmental Disorders Behavioral: Organizational Skills Training Behavioral: Waitlist Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/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.

Waitlist Behavioral: Waitlist
Will undergo two magnetic resonance imaging (MRI) sessions separated by a 12 week wait period. Will then undergo OST treatment




Primary Outcome Measures :
  1. Change in parent Children's Organizational Skills Scales (COSS-P) total T-scores following OST intervention [ Time Frame: Day 1 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108273


Contacts
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Contact: Yuliya Yoncheva 646-754-5147 yuliya.yoncheva@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Yuliya Yoncheva    646-754-5147    yuliya.yoncheva@nyulangone.org   
Principal Investigator: Francisco Castellanos, MD         
Sponsors and Collaborators
NYU Langone Health
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Francisco Castellanos, MD New York Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04108273    
Other Study ID Numbers: s17-00263
R61MH113663 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data will be provided to the NIMH Data Archive (NDA) for sharing to investigators
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Neurodevelopmental Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders