N/A
N=59
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
ADHD · Attention Deficit Hyperactivity Disorder · Neurodevelopmental Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04108273 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Default Mode Network Subdivision of the Anterior Ventral Striatum (aVS-DMN) — -0.07; 0.01 Fisher transformed z values
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Organizational Skills Training (Behavioral)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Default Mode Network Subdivision of the Anterior Ventral Striatum (aVS-DMN) |
-0.07; 0.01 | — |
| PRIMARY Change in Parent Children's Organizational Skills Scales (COSS-P) Total T-scores Following OST Intervention |
-14.8; -3.5 | — |
| PRIMARY Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Fronto Parietal Network Subdivision of the Anterior Ventral Striatum (aVS-FP) |
-0.13; -0.1 | — |
| PRIMARY Change in the Intrinsic Functional Connectivity (iFC) Between Dorsal Anterior Cingulate Cortex (dACC) and Limbic Network Subdivision of the Anterior Ventral Striatum (aVS-LIM) |
0.003; 0.0003 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04108273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.