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

NCT ID: NCT03148782

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-08
• Study Completion Date: 2019-05-01

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.

Conditions

ADHD; Attention Deficit Hyperactivity Disorder; Neurodevelopmental Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OST Intervention

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

Group Type: EXPERIMENTAL

OST Intervention for participants with Organizational skill difficulties

Intervention Type: BEHAVIORAL

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.

Interventions

OST Intervention for participants with Organizational skill difficulties

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco X Castellanos, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

R61MH113663

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R61/17-00263

Identifier Type: -

Identifier Source: org_study_id