Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

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

Sponsors

Lead sponsor: NYU Langone Health

Collaborator: National Institute of Mental Health (NIMH)

Source NYU Langone Health
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.

Overall Status Completed
Start Date September 8, 2017
Completion Date May 1, 2019
Primary Completion Date May 1, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in parent Children's Organizational Skills Scales (COSS-P) total T-scores following OST intervention. Day 1
Enrollment 42
Condition
Intervention

Intervention type: Behavioral

Intervention name: OST Intervention for participants with Organizational skill difficulties

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.

Arm group label: OST Intervention

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)

Gender: All

Minimum age: 8 Years

Maximum age: 11 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Francisco X Castellanos, MD Principal Investigator NYU Langone Health
Location
facility
New York University School of Medicine
Location Countries

United States

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: OST Intervention

Arm group type: Experimental

Description: 12 weekly in-person sessions, each lasting approximately 1 hour, targeting 3 core organizational skills domains-Tracking Assignments, Managing Materials and Time Management

Patient Data Yes
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov