Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

Study Overview
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Brief Summary
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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.

Official Title
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Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

Conditions
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ADHD, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders

Intervention / Treatment
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* Behavioral: Organizational Skills Training
* Behavioral: Waitlist


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OST Intervention<br> | Behavioral: Organizational Skills Training<br>* 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.<br>|
| Other: Waitlist<br> | Behavioral: Waitlist<br>* Will undergo two magnetic resonance imaging (MRI) sessions separated by a 12 week wait period. Will then undergo OST treatment<br>|

What is the study measuring?
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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 | The Children's Organizational Skills Scale quantifies how children (ages 8-13) organize their time, materials, and actions to accomplish important tasks at home and school. The Parent report consists of 66 questions, each using a 4-point Likert-type scale. T-scores can range between 40 and 90 | Day 1 |