- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02663986
Organizational Skill Training (OST) in Schools
February 3, 2020 updated by: NYU Langone Health
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 11 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Children with Mental Retardation will not participate in the study, due to the difficulty they would likely have understanding the content of the sessions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Organizational Skills Training (OST) Intervention
To improve children's organizational functioning, OST focuses on four key skills.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in scoring on Children's Organizational Skills Scale
Time Frame: 10 Weeks
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10 Weeks
|
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Change in score on Organizational Skills Scale-Parent (COSS-P)
Time Frame: 10 Weeks
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10 Weeks
|
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Change in score on Children's Organizational Skills Scale- (COSS-C)
Time Frame: 10 Weeks
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10 Weeks
|
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Change in score on Organizational Skills Scale-Teacher (COSS-T) Versions COSS-P, COSS-C, and COSS-T
Time Frame: 10 Weeks
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be used to assess OTMP functioning at home and at school
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10 Weeks
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Change in Homework Problem Checklist (HPCL) Score
Time Frame: 10 Weeks
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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
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10 Weeks
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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).
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10 Weeks
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Change in score on Consumer Satisfaction Questionnaire (CSQ)
Time Frame: 10 Weeks
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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.
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10 Weeks
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Measures of Feasibility
Time Frame: 10 Weeks
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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.
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10 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Howard B Abikoff, MD, New York University Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (ACTUAL)
June 28, 2016
Study Completion (ACTUAL)
June 28, 2016
Study Registration Dates
First Submitted
January 21, 2016
First Submitted That Met QC Criteria
January 21, 2016
First Posted (ESTIMATE)
January 26, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 3, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-02090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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