Status:
COMPLETED
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
ADHD
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
8-12 years
Phase:
NA
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 pe...
Eligibility Criteria
Inclusion
- 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 Children's Organizational Skills Scales (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
- 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)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04108273
Start Date
October 1 2019
End Date
August 1 2023
Last Update
August 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Langone Health
New York, New York, United States, 10016