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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

Tracking Information
First Submitted Date  ICMJE September 26, 2019
First Posted Date  ICMJE September 30, 2019
Last Update Posted Date November 10, 2020
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
Official Title  ICMJE Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • ADHD
  • Attention Deficit Hyperactivity Disorder
  • Neurodevelopmental Disorders
Intervention  ICMJE
  • 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.
  • Behavioral: Waitlist
    Will undergo two magnetic resonance imaging (MRI) sessions separated by a 12 week wait period. Will then undergo OST treatment
Study Arms  ICMJE
  • Experimental: OST Intervention
    Intervention: Behavioral: Organizational Skills Training
  • Waitlist
    Intervention: Behavioral: Waitlist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2019)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yuliya Yoncheva 646-754-5147 yuliya.yoncheva@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04108273
Other Study ID Numbers  ICMJE s17-00263
R61MH113663 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Francisco Castellanos, MD New York Langone Health
PRS Account NYU Langone Health
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP