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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148782
• Other study ID #: R61/17-00263
• Secondary ID: R61MH113663
• Status: Completed
• Phase: N/A
• Start date: September 8, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: September 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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)

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Neurodevelopmental Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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