Clinical trial NCT03148782: Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
Official title: Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Attention Deficit Hyperactivity Disorder
Neurodevelopmental Disorders
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-05-11
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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 ≥ 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in parent Children's Organizational Skills Scales (COSS-P) total T-scores following OST intervention.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Francisco X Castellanos, MD
role: PRINCIPAL_INVESTIGATOR
References: