Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

NCT ID: NCT04108273

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2023-08-01

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.

Conditions

ADHD; Attention Deficit Hyperactivity Disorder; Neurodevelopmental Disorders

Study Design

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

Study Groups

No-Wait

Participants with organizational skill difficulties to 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.

Group Type: EXPERIMENTAL

Organizational Skills Training

Intervention Type: BEHAVIORAL

OST targets three core organizational skills domains - Tracking Assignments, Managing Materials and Time Management - in a program consisting of sessions over 12 weeks, each training lasting about 1 hour, and corresponding 30-60 minute weekly review sessions with the parent and the child, 2-3 days following each training session.

Waitlist

Participants with organizational skill difficulties to undergo two magnetic resonance imaging (MRI) sessions: one 12 weeks prior to OST treatment and one \~12 weeks after their first scan and before proceeding to OST.

Group Type: ACTIVE_COMPARATOR

Organizational Skills Training

Intervention Type: BEHAVIORAL

OST targets three core organizational skills domains - Tracking Assignments, Managing Materials and Time Management - in a program consisting of sessions over 12 weeks, each training lasting about 1 hour, and corresponding 30-60 minute weekly review sessions with the parent and the child, 2-3 days following each training session.

Interventions

Organizational Skills Training

OST targets three core organizational skills domains - Tracking Assignments, Managing Materials and Time Management - in a program consisting of sessions over 12 weeks, each training lasting about 1 hour, and corresponding 30-60 minute weekly review sessions with the parent and the child, 2-3 days following each training session.

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 ≥ 8
• Organizational skills deficits defined as elevated (≥ 1SD) pre-treatment Children's Organizational Skills Scales (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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

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 Castellanos, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R61MH113663

Identifier Type: NIH

Identifier Source: secondary_id

View Link

s17-00263

Identifier Type: -

Identifier Source: org_study_id