Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Organizational Skills Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03443323
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
University of Pennsylvania
New York University
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
The purpose of this study is to evaluate the Organizational Skills Training Program - School based version (OST-S) in a cluster randomized trial. Participating schools will be randomly assigned to one of two groups: 1) an OST-S intervention group and 2) a treatment as usual control group. Participating students (3rd through 5th grade) will be from 20 schools in Pennsylvania and New Jersey and include both urban and suburban schools serving a diverse population. OST-S 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.

Condition or disease Intervention/treatment Phase
Executive Function Behavioral Research Schools Behavior Therapy Behavioral: Organizational Skills Training - School Based (OST-S) Not Applicable

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 Goal 3 efficacy study is to conduct an evaluation of the Organizational Skills Training Program - School version (OST-S), 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 OST-S 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 are located in Pennsylvania and New Jersey and include 20 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-S 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-S 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 will measure the following: intervention fidelity, stakeholder engagement, student OTMP skills, student academic self-efficacy, student academic outcomes, student characteristics, feasibility, usability, and acceptability of OST-S. In addition, Investigators will track the interventions that are offered as treatment-as-usual in TAU schools. A cost analysis related to the implementation of OST-S will also be completed.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Organizational Skills Training (OST) Program for Upper Elementary Students
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
Experimental: OST-S Intervention group Behavioral: Organizational Skills Training - School Based (OST-S)
OST-S 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-S 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



Primary Outcome Measures :
  1. Changes in Students' Organizational Functioning [ Time Frame: Baseline, 10-weeks (post-treatment), 5-months and 12-months ]
    The Children's Organizational Skills Scales (COSS) will be 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). Although the COSS yields three subscale scores, only the total score will be used to reduce the number of measures in the analyses.

  2. Changes in students' patterns of adaptive learning [ Time Frame: Baseline, 10-weeks (post-treatment), 5-months and 12-months ]
    Patterns of Adaptive Learning Scales (PALS) will be used to evaluate changes in students' perceptions of their competence in completing their classwork. Items are rated on a 5-item scale from 1 = not at all true to 5 = very true.


Secondary Outcome Measures :
  1. Changes in Student's Academic Progress [ Time Frame: Baseline, 10-weeks (post-treatment), 5-months and 12-months ]
    The Academic Progress Report (APR) is a teacher-report measure that assesses (changes in) proficiency in seven 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 seven academic subjects is the unit of analysis. Reliability is acceptable (alpha = .84), and this measure is sensitive to OST treatment effects.

  2. Changes in academic Competence of Students [ Time Frame: Baseline, 10-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 will be used. Alpha coefficients and test-retest correlations for these subscales have been shown to be above .90. The average of these subscale scores will be used in the analyses.

  3. Academic grades of students [ Time Frame: Baseline, 10-weeks (post-treatment), 5-months and 12-months ]
    Student report card grades for the marking period prior to students' participation in OST-S/TAU and for the marking period immediately after the intervention and follow-up periods. For students enrolled before the first marking period is over, baseline grades will be those obtained at the end of the previous school year.

  4. Completion of classwork/homework samples [ Time Frame: Baseline, 10-weeks (post-treatment), 5-months and 12-months ]
    Teachers will submit copies of students' classwork and homework for a 2-week period coinciding with each assessment period (noted below in "time frame"). In addition, teachers will submit a list of classwork and homework assigned during each assessment period, so that it can be determined whether assignments were completed. The study team member will randomly select three classwork and homework assignments to score. The accuracy of work completed as a function of work assigned will be computed for each sample. Accuracy in completing assignments has been demonstrated to be moderately correlated (p<.01) with teacher ratings of inattention and teacher ratings of homework responsibility.

  5. Students' Homework Performance [ Time Frame: Baseline, 10-weeks (post-treatment), 5-months and 12-months ]
    The Homework Performance Questionnaire (HPQ-T)-Teacher version will be used to assess changes in students' homework behavior during the past 4 weeks. Each item is rated on a five-point scale. The 9-item Student Self-Regulation factor will be used in the analyses. This factor has been demonstrated to have strong psychometric properties.

  6. Parent's report of changes in their child's homework performance [ Time Frame: Baseline, 10-weeks (post-treatment), 5-months and 12-months ]
    The Homework Problem Checklist (HPC) is a 20-item parent-report measure that will be used to assess changes in student homework performance. 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 will be used in the analyses.

  7. Changes in Participants' views of treatment Acceptability [ Time Frame: up to 10-weeks (post treatment) ]

    Measures of Acceptability of OST-S will be assessed using the following measure:

    The Treatment Evaluation Inventory - Short Form (TEI-SF), a 9-item measure, will be used to assess parents' views of treatment acceptability.


  8. Changes in Participants' views of treatment Usability [ Time Frame: up to 10-weeks (post treatment) ]
    The Usage Rating Profile-Intervention-Revised (URP-IR), a 29-item measure, will be adapted (with permission) to assess factors that may influence the usage of the OST-S intervention in a school-based setting.

  9. Changes in Participants' views of treatment Feasibility [ Time Frame: up to 10-weeks (post treatment) ]
    The Usage Rating Profile-Intervention-Revised (URP-IR), a 29-item measure, will be adapted (with permission) to assess feasibility of usage of the OST-S intervention in a school-based setting.

  10. Changes in Participants' views of treatment Acceptability [ Time Frame: up to 10-weeks (post treatment) ]
    The Children's Intervention Rating Profile (CIRP), a 7-item measure, will be adapted to assess student's perceptions of acceptability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Any student enrolled in grades 3 thru 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443323


Contacts
Layout table for location contacts
Contact: Katie L Tremont, MPH 267-425-1933 tremontk@email.chop.edu
Contact: Jaclyn Cacia, MS 267-426-6015 caciaj@email.chop.edu

Locations
Layout table for location information
United States, New York
New York University Active, not recruiting
New York, New York, United States, 10016
United States, Pennsylvania
University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Childrens Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Katie L Tremont, MPH    267-425-1933    tremontk@email.chop.edu   
Contact: Jaclyn Cacia, MS    267-426-6015    caciaj@email.chop.edu   
Principal Investigator: Thomas J Power, PhD, ABCT         
Principal Investigator: Jenelle Nissley-Tsiopinis, PhD         
Principal Investigator: Jennifer Mautone, PhD, NCSP, ABPP         
Sub-Investigator: Abbas F Jawad, PhD, MSc         
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
New York University
Investigators
Layout table for investigator information
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 Childrens Hospital of Philadelphia

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03443323     History of Changes
Other Study ID Numbers: 17-014227
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.
Access Criteria: Individuals interested in using the data should contact Dr. Thomas Power (power@email.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. Therefore, per Children's Hospital of Philadelphia (CHOP) policies, a data licensing agreement is anticipated to not be necessary.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital of Philadelphia:
Executive Function
Behavioral Research
Cost Analysis
Students
Schools
Randomized Controlled Trial
Behavior Therapy