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

Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

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.

Study Overview

• Status: Completed
• Conditions: ADHD; Neurodevelopmental Disorders; Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: OST Intervention for participants with Organizational skill difficulties

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parent Children's Organizational Skills Scales (COSS-P) total T-scores following OST intervention.	Parents (COSS-P) and teachers (COSS-T) will serve as informants (only the child is a study subject) who will provide baseline and outcome ratings.	Day 1

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Francisco X Castellanos, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Attention Deficit and Disruptive Behavior Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders
• Other Study ID Numbers: R61/17-00263; R61MH113663 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data will be provided to the National Database for Clinical Trials Related to Mental Illness (NDCT) for sharing to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No