Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase

Completed · Not applicable

Conditions studied: ADHD, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders

In brief

Organizational, time management and planning (OTMP) skills deficits are seriously impairing features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD) and autism, 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 with non-invasive MRI imaging in a pre-/post-design to address this question.

Key facts

Study ID: NCT03148782
Run by: NYU Langone Health
People needed: 42
Starts: 2017-09-08
Expected to finish: 2019-05-01
Last updated by the study team: 2019-10-01

Who can join

Age: 8 and older, up to 11. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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 ≥ 80 is required as in past studies to assure that children are able to comply with specific skills training and to minimize neurobiological heterogeneity
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)
Handedness: given the greater prevalence of non-right-handedness in neurodevelopmental disorders, we will track handedness but not exclude left-handed individuals
Medication: To minimize variability due to medication effects, we will preferentially recruit currently unmedicated individuals (no psychoactive medications in the previous 3 months). For stimulants, we will require that dosage be stable for >1 month before study entry and parents will be asked to consult their physician regarding discontinuation for 48 hours before evaluation, mock scanning and scanning sessions.
Must provide adequate MRI data at baseline

You may not qualify if…

Enrolled in a self-contained special education classroom or served by a 1:1 paraprofessional in their classroom
A learning disability on Individualized Education Plan
Absence of signed consent by parent or legal guardian
Children who dissent regardless of parental permission
Full scale IQ < 85
Participants for whom stimulant discontinuation for 48 hours prior to evaluation, mock scan and scanning sessions is deemed medically impermissible
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)

Where it is running

New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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