Attention Deficit Hyperactivity Disorder (ADHD)NCT02663986
Organizational Skill Training (OST) in Schools
A study testing Organizational Skills Training (OST) Intervention in people with Attention Deficit Hyperactivity Disorder (ADHD), run by NYU Langone Health at 1 site in United States.
Trial summary
The primary aim of this project is to address the need for an effective school-based intervention for elementary school-aged students with Organization, Time Management, and Planning (OTMP) deficits by adapting an evidence-supported clinic-based intervention so that it can be implemented in school settings. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Organizational Skills Training (OST) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 28 Jun 2016
- 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
- No healthy volunteers
- Child
Who may be able to join
- Children will be recruited based on their parents' interest level in having them participate in a program to improve their organizational skills.
- Investigators will consider feedback from their 3rd to 5th grade general education or inclusion classroom teacher based on OTMP problems difficulties that interfere with functioning (difficulty in morning routine or end-of-day packing up routine, a high percentage of incomplete or missing assignments, messy desk or Seat Sack).
- Investigators will not use specific cutoffs on normed measures for determining eligibility based on these difficulties, as the intention is to develop a program that can be easily disseminated.
- Availability to attend twice-weekly sessions with the OTMP trainer either during the school day (during a time when they would not be pulled from academic content) or during after-school hours.
Who cannot join
- Children with Mental Retardation will not participate in the study, due to the difficulty they would likely have understanding the content of the sessions.
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: A School-Based Program to Improve Children's Organizational Skills
The primary aim of this project is to address the need for an effective school-based intervention for elementary school-aged students with Organization, Time Management, and Planning (OTMP) deficits by adapting an evidence-supported clinic-based intervention so that it can be implemented in school settings. Investigators are learning to adapt an individual, clinic based program (OST-C) for children diagnosed with Attention Deficit Hyperactive Disorder (ADHD) to children with OTMP problems. Investigators will be collecting data . To this end, investigators will be collecting data on implementation (such as feasibility and acceptability), program development (what changes to the individual OST-C program were made based on findings during this study) and limited outcome data (repeated measures collection and pre- and post-treatment collection on a small sample, no control group).
- Being tested
- Organizational Skills Training (OST) Intervention
- Keywords
- Organization, Time Management, and Planning (OTMP)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organizational Skills Training (OST) InterventionBehavioural
Also called Organization, Time Management, and Planning (OTMP)
| Study group | Role | What they receive |
|---|---|---|
| Organizational Skills Training (OST) Intervention | Experimental | To improve children's organizational functioning, OST focuses on four key skills.
* Tracking Assignments
* Managing Materials
* Time Management
* Task Planning Receives: Behavioral: Organizational Skills Training (OST) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scoring on Children's Organizational Skills Scale
Measured: 10 Weeks
Change in score on Organizational Skills Scale-Parent (COSS-P)
Measured: 10 Weeks
Change in score on Children's Organizational Skills Scale- (COSS-C)
Measured: 10 Weeks
Change in score on Organizational Skills Scale-Teacher (COSS-T) Versions COSS-P, COSS-C, and COSS-T
be used to assess OTMP functioning at home and at school
Measured: 10 Weeks
Change in Homework Problem Checklist (HPCL) Score
The HPCL (Anesko, Schoiock, Ramirez, \& Levine, 1987) was designed to assess various aspects of homework performance. Parents are requested to rate each of 20 homework problems on a scale from 0 = never a problem to 3 = very often a problem
Measured: 10 Weeks
Change in score on Academic Progress Report (APR)
The APR (Abikoff et al, 2013) assesses proficiency in six academic subjects relative to standard expectations (1=Well below standard expected at this time of year; 3=At standard; 5=Well above standard). The sum of ratings across the six academic subjects is the unit of analysis. Reliability is acceptable (coefficient alpha = .84), and this measure is sensitive to OST treatment effects (Abikoff et al., 2013).
Measured: 10 Weeks
Change in score on Consumer Satisfaction Questionnaire (CSQ)
To assess satisfaction with treatment, and to serve as an index of treatment credibility, a consumer satisfaction questionnaire adapted from McMahon and Forehand (2003), will be completed by parents and teachers at post-treatment. Items (rated 1-7) tap overall satisfaction with treatment, perceived improvement of the child on the problems of concern to parent or teacher respectively, and evaluation of treatment providers.
Measured: 10 Weeks
Measures of Feasibility
Investigators will gather feasibility data based on completed activities during the study. They will record information about treatment training, number of groups run, number of students per group, scheduling challenges, number of meetings/contacts OST-S trainers had with teachers and parents, materials support, or any other items related to implementing the program will be recorded for the duration of the study.
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start1 Feb 2015
- Primary completion28 Jun 2016
- Study completion28 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard B Abikoff, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663986
- Sponsor's protocol ID
- 14-02090
- Status last verified
- Feb 2020
- First submitted
- 21 Jan 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School-Based Program to Improve Children's Organizational Skills
- ClinicalTrials.gov ID
- NCT02663986
- Acronym / sponsor ID
- 14-02090
- Keywords
- Organization, Time Management, and Planning (OTMP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Feb 2015
- Primary completion
- 28 Jun 2016 (actual)
- Study completion
- 28 Jun 2016 (actual)
- First posted
- 26 Jan 2016 (estimated)
- 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.
The primary aim of this project is to address the need for an effective school-based intervention for elementary school-aged students with Organization, Time Management, and Planning (OTMP) deficits by adapting an evidence-supported clinic-based intervention so that it can be implemented in school settings. Investigators are learning to adapt an individual, clinic based program (OST-C) for children diagnosed with Attention Deficit Hyperactive Disorder (ADHD) to children with OTMP problems. Investigators will be collecting data . To this end, investigators will be collecting data on implementation (such as feasibility and acceptability), program development (what changes to the individual OST-C program were made based on findings during this study) and limited outcome data (repeated measures collection and pre- and post-treatment collection on a small sample, no control group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Organizational Skills Training (OST) Intervention | Experimental | Behavioral: Organizational Skills Training (OST) InterventionTo improve children's organizational functioning, OST focuses on four key skills. * Tracking Assignments * Managing Materials * Time Management * Task Planning |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children will be recruited based on their parents' interest level in having them participate in a program to improve their organizational skills.
- Investigators will consider feedback from their 3rd to 5th grade general education or inclusion classroom teacher based on OTMP problems difficulties that interfere with functioning (difficulty in morning routine or end-of-day packing up routine, a high percentage of incomplete or missing assignments, messy desk or Seat Sack).
- Investigators will not use specific cutoffs on normed measures for determining eligibility based on these difficulties, as the intention is to develop a program that can be easily disseminated.
- Availability to attend twice-weekly sessions with the OTMP trainer either during the school day (during a time when they would not be pulled from academic content) or during after-school hours.
Key exclusion criteria (1 listed)
- Children with Mental Retardation will not participate in the study, due to the difficulty they would likely have understanding the content of the sessions.
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 |
|---|---|---|
| Organizational Skills Training (OST) InterventionAlso: Organization, Time Management, and Planning (OTMP) | Behavioural | Organizational Skills Training (OST) Intervention |
Primary outcome
Change in scoring on Children's Organizational Skills Scale
Time frame: 10 Weeks
Change in score on Organizational Skills Scale-Parent (COSS-P)
Time frame: 10 Weeks
Change in score on Children's Organizational Skills Scale- (COSS-C)
Time frame: 10 Weeks
Change in score on Organizational Skills Scale-Teacher (COSS-T) Versions COSS-P, COSS-C, and COSS-T
Time frame: 10 Weeks
be used to assess OTMP functioning at home and at school
Change in Homework Problem Checklist (HPCL) Score
Time frame: 10 Weeks
The HPCL (Anesko, Schoiock, Ramirez, \& Levine, 1987) was designed to assess various aspects of homework performance. Parents are requested to rate each of 20 homework problems on a scale from 0 = never a problem to 3 = very often a problem
Change in score on Academic Progress Report (APR)
Time frame: 10 Weeks
The APR (Abikoff et al, 2013) assesses proficiency in six academic subjects relative to standard expectations (1=Well below standard expected at this time of year; 3=At standard; 5=Well above standard). The sum of ratings across the six academic subjects is the unit of analysis. Reliability is acceptable (coefficient alpha = .84), and this measure is sensitive to OST treatment effects (Abikoff et al., 2013).
Change in score on Consumer Satisfaction Questionnaire (CSQ)
Time frame: 10 Weeks
To assess satisfaction with treatment, and to serve as an index of treatment credibility, a consumer satisfaction questionnaire adapted from McMahon and Forehand (2003), will be completed by parents and teachers at post-treatment. Items (rated 1-7) tap overall satisfaction with treatment, perceived improvement of the child on the problems of concern to parent or teacher respectively, and evaluation of treatment providers.
Measures of Feasibility
Time frame: 10 Weeks
Investigators will gather feasibility data based on completed activities during the study. They will record information about treatment training, number of groups run, number of students per group, scheduling challenges, number of meetings/contacts OST-S trainers had with teachers and parents, materials support, or any other items related to implementing the program will be recorded for the duration of the study.
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Howard B Abikoff, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organizational Skills Training (OST) Intervention in people with Attention Deficit Hyperactivity Disorder (ADHD), 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 4 inclusion and 1 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 5 Feb 2020. 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 scoring on Children's Organizational Skills Scale (time frame: 10 Weeks). The study lists 8 primary outcomes in all. 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 5 Feb 2020.