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

Primary Purpose

ADHD, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OST Intervention for participants with Organizational skill difficulties
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OST Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2017
Last Updated
September 27, 2019
Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03148782
Brief Title
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
Official Title
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 8, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OST Intervention
Arm Type
Experimental
Arm Description
12 weekly in-person sessions, each lasting approximately 1 hour, targeting 3 core organizational skills domains-Tracking Assignments, Managing Materials and Time Management
Intervention Type
Behavioral
Intervention Name(s)
OST Intervention for participants with Organizational skill difficulties
Intervention 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.
Primary Outcome Measure Information:
Title
Change in parent Children's Organizational Skills Scales (COSS-P) total T-scores following OST intervention.
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco X Castellanos, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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