Back to resultsOrganizational Skill Training (OST) in Schools
Primary Purpose
Attention Deficit Hyperactivity Disorder (ADHD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Organizational Skills Training (OST) Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring Organization, Time Management, and Planning (OTMP)
Eligibility Criteria
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Organizational Skills Training (OST) Intervention
Arm Description
To improve children's organizational functioning, OST focuses on four key skills. Tracking Assignments Managing Materials Time Management Task Planning
Outcomes
Primary Outcome Measures
Change in scoring on Children's Organizational Skills Scale
Change in score on Organizational Skills Scale-Parent (COSS-P)
Change in score on Children's Organizational Skills Scale- (COSS-C)
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
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
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).
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02663986
Brief Title
Organizational Skill Training (OST) in Schools
Official Title
A School-Based Program to Improve Children's Organizational Skills
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (undefined)
Primary Completion Date
June 28, 2016 (Actual)
Study Completion Date
June 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
Organization, Time Management, and Planning (OTMP)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Organizational Skills Training (OST) Intervention
Arm Type
Experimental
Arm Description
To improve children's organizational functioning, OST focuses on four key skills.
Tracking Assignments
Managing Materials
Time Management
Task Planning
Intervention Type
Behavioral
Intervention Name(s)
Organizational Skills Training (OST) Intervention
Other Intervention Name(s)
Organization, Time Management, and Planning (OTMP)
Primary Outcome Measure Information:
Title
Change in scoring on Children's Organizational Skills Scale
Time Frame
10 Weeks
Title
Change in score on Organizational Skills Scale-Parent (COSS-P)
Time Frame
10 Weeks
Title
Change in score on Children's Organizational Skills Scale- (COSS-C)
Time Frame
10 Weeks
Title
Change in score on Organizational Skills Scale-Teacher (COSS-T) Versions COSS-P, COSS-C, and COSS-T
Description
be used to assess OTMP functioning at home and at school
Time Frame
10 Weeks
Title
Change in Homework Problem Checklist (HPCL) Score
Description
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
Time Frame
10 Weeks
Title
Change in score on Academic Progress Report (APR)
Description
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).
Time Frame
10 Weeks
Title
Change in score on Consumer Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
10 Weeks
Title
Measures of Feasibility
Description
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.
Time Frame
10 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard B Abikoff, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Organizational Skill Training (OST) in Schools
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