Back to resultsBrain Plasticity Underlying Acquisition of New Organizational Skills in Children
Primary Purpose
ADHD, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Organizational Skills Training
Waitlist
Sponsored by
About this trial
This is an interventional treatment trial for ADHD
Eligibility 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)
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
OST Intervention
Waitlist
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04108273
First Posted
September 26, 2019
Last Updated
June 29, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04108273
Brief Title
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
Official Title
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OST Intervention
Arm Type
Experimental
Arm Title
Waitlist
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Organizational Skills Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist
Intervention Description
Will undergo two magnetic resonance imaging (MRI) sessions separated by a 12 week wait period. Will then undergo OST treatment
Primary Outcome Measure Information:
Title
Change in parent Children's Organizational Skills Scales (COSS-P) total T-scores following OST intervention
Description
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
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Castellanos, MD
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data will be provided to the NIMH Data Archive (NDA) for sharing to investigators
Learn more about this trial
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
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