Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

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 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.

Overall Status Recruiting
Start Date October 1, 2019
Completion Date December 2020
Primary Completion Date December 2020
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 144
Condition
Intervention

Intervention type: Behavioral

Intervention name: Organizational Skills Training

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

Intervention type: Behavioral

Intervention name: Waitlist

Description: Will undergo two magnetic resonance imaging (MRI) sessions separated by a 12 week wait period. Will then undergo OST treatment

Arm group label: Waitlist

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)

Gender: All

Minimum age: 8 Years

Maximum age: 12 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Francisco Castellanos, MD Principal Investigator New York Langone Health
Overall Contact

Last name: Yuliya Yoncheva

Phone: 646-754-5147

Email: [email protected]

Location
facility status contact investigator
NYU Langone Health Recruiting Yuliya Yoncheva 646-754-5147 [email protected] Francisco Castellanos, MD Principal Investigator
Location Countries

United States

Verification Date

December 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: OST Intervention

Arm group type: Experimental

Arm group label: Waitlist

Arm group type: Other

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov