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Completed

NCT Number: NCT03148782

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

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.

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Key information

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

OST Intervention for participants with Organizational skill difficulties

Behavioral

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 outcomes

  1. Change in parent Children's Organizational Skills Scales (COSS-P) total T-scores following OST intervention.

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 11, 2017
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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