Organizational Skills Training - Tier 2 (OST-T2)

October 29, 2024 updated by: Children's Hospital of Philadelphia

Evaluation of Organizational Skills Training (OST) Program for Upper Elementary Students

The purpose of this study was to evaluate the Organizational Skills Training Program - Tier 2 version (OST-T2) in a cluster randomized trial. Participating schools will be randomly assigned to one of two groups: 1) an OST-T2 intervention group and 2) a treatment as usual control group. Participating students (3rd through 5th grade) were from 22 schools in Pennsylvania and New Jersey and included both urban and suburban schools serving a diverse population. OST-T2 is a small-group, skills training intervention for children, which includes parent and teacher consultation to support student use of new skills. The program is delivered by school staff who receive training and consultation from intervention experts.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Context: Although multiple factors influence school functioning, executive function (EF) deficits have been found to be a key predictor of academic achievement. EF is a higher order cognitive ability associated with persistent goal-directed behavior. Organization, time management, and planning (OTMP) skills are aspects of EF that are particularly associated with children's academic performance. Organizational demands increase over the course of early schooling and are relatively high by 3rd through 5th grade. Poor OTMP skills during this period adversely impact academic functioning. In the late elementary school grades, as students are expected to become more organized, some students have difficulty learning these skills in spite of classroom supports provided by teachers, placing them at increased risk for academic failure.

Objectives: The purpose of this study was to conduct an evaluation of the Organizational Skills Training Program - Tier 2 version (OST-T2), a fully developed intervention for students in general education. The proposed study builds upon research demonstrating the efficacy of a clinic-based version of the OST intervention (OST-C) in remediating OTMP skills deficits and improving academic functioning for 3rd, 4th and 5th graders with attention-deficit hyperactivity disorder (ADHD), and a recent pilot research demonstrating the feasibility and potential effectiveness of a school-based version of OST provided by end users ("school partners") for 3rd through 5th graders. It also builds upon research training school staff to implement evidence-based interventions with high fidelity.

Study Design: This is a cluster-randomized trial with a treatment as usual (TAU) control group.

Setting/Participants: Schools (22) were located in Pennsylvania and New Jersey and include urban and suburban schools serving a diverse population. Students (3rd to 5th grade) who are struggling the most with OTMP deficits and whose academic performance is negatively impacted by their OTMP deficits will be referred to the study team by their general education teachers.

Study Interventions and Measures: OST-T2 is a small group skills training intervention, with parents and teachers supporting children's use of new skills. The program manual includes strategies for training and coaching school staff, referred to as school partners, to effectively implement OST-T2 and guidelines to modify the program for implementation in diverse schools with diverse students. Each student session includes: (a) homework review to assess completion of between-session skills implementation; (b) skill-building activities, which include the use of modeling, shaping, guided practice, and reinforcement for organized behavior; and (c) activities to promote generalization of skills. Sessions address four organizational challenges: (a) tracking assignments, (b) managing materials, (c) managing time, and (d) planning for long term assignments.

Investigators measured the following: intervention fidelity, stakeholder engagement, student OTMP skills, student academic self-efficacy, student academic outcomes, student characteristics, feasibility, usability, and acceptability of OST-T2. In addition, investigators tracked the interventions that are offered as treatment-as-usual in TAU schools. A cost analysis related to the implementation of OST-T2 will also be completed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Children's Hospital of Philadelphia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Any student enrolled in grades 3 through 5 in one of the participating schools who meets the following criteria.

  1. First, students will be recommended by their general education teacher if the following are true: (a) students who are struggling the most with OTMP skills, (b) whose OTMP skill deficits are the students' primary concern (c) whose academic performance is negatively impacted by their OTMP deficits, and (d) who have at least one parent who speaks English.
  2. Second, students must have or be at risk for developing OTMP deficits.

Exclusion Criteria:

  1. Students will be excluded if they are in a pull-out special education classroom for more than 50% of the day as the organizational demands for these students may differ from those students placed mostly in general education.
  2. Students with a one-to-one aide will be excluded because the presence of an aide substantially alters how an organizational intervention is implemented.
  3. Students from families in which both caregivers do not speak English will be excluded because the program has not yet been developed for non-English speakers.
  4. Only one student per family will be included in the study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OST-T2 Intervention group
Small group skills training for students in grades 3 through 5 with difficulties with organization, time management, and planning skills. Includes parent and teacher involvement to support student skills use.
Behavioral: Organizational Skills Training - Tier 2 (OST-T2)
OST-T2 is a small group skills training intervention, with parents and teachers supporting children's use of new skills. The program manual includes strategies for training and coaching school staff, referred to as school partners, to effectively implement OST-T2 and guidelines to modify the program for implementation in diverse schools with diverse students. Each student session includes: (a) homework review to assess completion of between-session skills implementation; (b) skill-building activities, which include the use of modeling, shaping, guided practice, and reinforcement for organized behavior; and (c) activities to promote generalization of skills. Sessions address four organizational challenges: (a) tracking assignments, (b) managing materials, (c) managing time, and (d) planning for long term assignments.
No Intervention: Treatment as usual control group
Strategies currently in use by schools to address organization, time management, and planning skills problems.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Students' Organizational Functioning - Teacher Report
Time Frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
The Children's Organizational Skills Scales - Teacher Version (COSS-T) was used to assess changes in OTMP functioning at home and school over several time points. COSS total scores have good discriminant validity and are sensitive to treatment effects. Each COSS version uses a 4-point rating scale (1=Hardly ever or never to 4=Just about all of the time). Higher scores indicate a worse outcome. Although the COSS yields three subscale scores, only the total score of 28 items was used to reduce the number of measures in the analyses. The mean item score was calculated and used in analyses; possible range is from 1 to 4.
Baseline, 14-weeks (post-treatment), 5-months and 12-months
Students' Organizational Functioning - Parent Report
Time Frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
The Children's Organizational Skills Scales - Parent Version (COSS-P) was used to assess changes in OTMP functioning at home and school over several time points. COSS total scores have good discriminant validity and are sensitive to treatment effects. Each COSS version uses a 4-point rating scale (1=Hardly ever or never to 4=Just about all of the time). Higher scores indicate a worse outcome. Although the COSS yields three subscale scores, only the 26-item total score was used to reduce the number of measures in the analyses. The mean item score was calculated and used in analyses; possible range is from 1 to 4.
Baseline, 14-weeks (post-treatment), 5-months and 12-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Students' Homework Performance - Teacher Report
Time Frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
The Homework Performance Questionnaire (HPQ-T)-Teacher version was used to assess changes in students' homework behavior during the past 4 weeks. Each item is rated on a five-point scale corresponding to amount of time student demonstrated the behavior in the previous 4-week period (0 = 0% to 39% of the time; 1 = 40% to 69% of the time; 2 = 70% to 79% of the time; 3 = 80% to 89% of the time; 4 = 90% to 100% of the time).Higher scores indicate better outcome. The 9-item Student Self-Regulation factor was used in the analyses. This factor has been demonstrated to have strong psychometric properties. Mean item score was used in analyses; possible range is from 0 to 4.
Baseline, 14-weeks (post-treatment), 5-months and 12-months
Students' Homework Performance - Parent Report
Time Frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
The Homework Problem Checklist (HPC) is a 20-item parent-report measure that was used to assess changes in student homework performance. Parents indicate the frequency with which student engage in behavior during homework time at home on a four-point scale (0 = never to 3 = very often). The psychometric properties of this instrument have been shown to be acceptable, and the HPC was sensitive to treatment effects in the previous OST-C study. The total HPC score was used in the analyses. Higher scores indicate worse outcomes. Mean item score was calculated and used in analyses; possible range is from 0 to 3.
Baseline, 14-weeks (post-treatment), 5-months and 12-months
Student Academic Proficiency
Time Frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
The Academic Proficiency Scale (APS) is a teacher-report measure that assesses (changes in) 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). Higher scores indicate a better outcome. Ratings were averaged across six academic subjects; mean item score is the unit of analysis. Possible range is from 1 to 5. Reliability is acceptable (alpha = .84), and this measure is sensitive to OST treatment effects.
Baseline, 14-weeks (post-treatment), 5-months and 12-months
Student Academic Competence
Time Frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
The Academic Competence Evaluation Scales (ACES) is a teacher-report scale that assesses changes in the academic competence of students in kindergarten through grade 12. The Reading/Language Arts and Math subscales of this measure were used. Items are rated from 1 = far below to 5 = far above grade level. Higher scores indicate better outcome. Alpha coefficients and test-retest correlations for these subscales have been shown to be above .90. The average item score for Reading/Language Arts (11 items) and Math (8 items) subscales were calculated. Then the average of these subscale scores was used in the analyses. Possible range is from 1 to 5.
Baseline, 14-weeks (post-treatment), 5-months and 12-months
Student Academic Grades
Time Frame: Baseline, 5-months
Student report card grades for the first marking period of the year students participate in OST-T2/TAU and for the last marking period of the academic year of participation were used to examine impact on academic performance. Grades were harmonized across participating school districts to a uniform grading scale (ranging from low of 1 to high of 4). A composite academic grade score was computed for each student based on their grades in math and reading/language arts (possible range = 1 to 4). Higher scores indicate better outcomes.
Baseline, 5-months
Student Self-efficacy
Time Frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
Patterns of Adaptive Learning Scales (PALS) was used to evaluate changes in students' perceptions of their ability to overcome challenges to perform their class work (e.g., "I can do even the hardest work in this class if I try."). Items are rated on a 5-item scale from 1 = not at all true to 5 = very true. Higher scores indicate better outcomes. Mean item scores were used in analyses; possible range is from 1 to 5.
Baseline, 14-weeks (post-treatment), 5-months and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Philadelphia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pennsylvania
New York University
U.S. Department of Education

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Power, PhD, Children's Hospital of Philadelphia
  • Principal Investigator: Jenelle Nissley-Tsiopoinis, PhD, Children's Hospital of Philadelphia
  • Principal Investigator: Jennifer Mautone, PhD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-014227
  • R305A170052-20 (Other Grant/Funding Number: US Dept. of Education)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Per Institute for Educational Sciences (IES) requirements, the timeframe for accessibility of data will be reviewed during each annual progress review and revised as necessary. The final dataset will be exported from REDCap to Microsoft Excel and commonly used statistical software packages such as SPSS and SAS, as requested by the individuals seeking access to the data. The research team will prepare a codebook to share with the requesting individuals. The codebook will provide information about all of the variables and how the composite variables (e.g. factor scores) were derived.

IPD Sharing Time Frame

Data will become accessible after the study is completed and primary study findings are published in a peer-reviewed journal. Data will be available for 10 years from that time. Per Institute for Educational Sciences (IES) requirements, the timeframe for accessibility of data will be reviewed during each annual progress review and revised as necessary.

IPD Sharing Access Criteria

Individuals interested in using the data should contact Dr. Thomas Power (power@chop.edu). When our research team receives a request for access to the data a data file and supporting documentation will be prepared by the research team. Only de-identified data will be made accessible in order to prevent identification of students, parents, and school staff who participated in this project. Per Children's Hospital of Philadelphia (CHOP) policies, a data use agreement is necessary prior to sharing data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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