ADHDNCT03148782
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
A study testing OST Intervention for participants with Organizational skill difficulties in people with ADHD and Attention Deficit Hyperactivity Disorder, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders
- What is being tested?
- OST Intervention for participants with Organizational skill difficulties
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2017to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
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.
- Being tested
- OST Intervention for participants with Organizational skill difficulties
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OST Intervention for participants with Organizational skill difficultiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| OST Intervention | Experimental | 12 weekly in-person sessions, each lasting approximately 1 hour, targeting 3 core organizational skills domains-Tracking Assignments, Managing Materials and Time Management Receives: Behavioral: OST Intervention for participants with Organizational skill difficulties |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start8 Sep 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Francisco X Castellanos, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148782
- Sponsor's protocol ID
- R61/17-00263
- Other IDs
- R61MH113663
- Status last verified
- Sep 2019
- First submitted
- 9 May 2017
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
- ClinicalTrials.gov ID
- NCT03148782
- Acronym / sponsor ID
- R61/17-00263
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OST Intervention | Experimental | Behavioral: OST Intervention for participants with Organizational skill difficulties12 weekly in-person sessions, each lasting approximately 1 hour, targeting 3 core organizational skills domains-Tracking Assignments, Managing Materials and Time Management |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OST Intervention for participants with Organizational skill difficultiesWill 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. | Behavioural | OST Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco X Castellanos, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OST Intervention for participants with Organizational skill difficulties in people with ADHD and Attention Deficit Hyperactivity Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parent Children's Organizational Skills Scales (COSS-P) total T-scores following OST intervention. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.