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Executive FunctionNCT03443323

Organizational Skills Training - Tier 2 (OST-T2)

A study testing Organizational Skills Training - Tier 2 (OST-T2) in people with Executive Function and Behavioral Research, run by Children's Hospital of Philadelphia at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Executive Function, Behavioral Research, Schools
What is being tested?
Organizational Skills Training - Tier 2 (OST-T2)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
3 sitesUnited States
Study dates
8 Nov 2017to 30 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Any student enrolled in grades 3 through 5 in one of the participating schools who meets the following criteria.
  • 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.
  • Second, students must have or be at risk for developing OTMP deficits.

Who cannot join

  • 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.
  • Students with a one-to-one aide will be excluded because the presence of an aide substantially alters how an organizational intervention is implemented.
  • 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.
  • Only one student per family will be included in the study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • New York University

    New York, New York, 10016

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19146

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Organizational Skills Training - Tier 2 (OST-T2)
Keywords
Executive Function, Behavioral Research, Cost Analysis, Students, Schools, Randomized Controlled Trial, Behavior Therapy, Skills Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Organizational Skills Training - Tier 2 (OST-T2)Behavioural

    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.

Study groups in NCT03443323
Study groupRoleWhat they receive
OST-T2 Intervention groupExperimentalSmall 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.
Receives: Behavioral: Organizational Skills Training - Tier 2 (OST-T2)
Treatment as usual control groupNo interventionStrategies currently in use by schools to address organization, time management, and planning skills problems.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Students' Organizational Functioning - Teacher Report

    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.

    Measured: Baseline, 14-weeks (post-treatment), 5-months and 12-months

  2. Students' Organizational Functioning - Parent Report

    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.

    Measured: Baseline, 14-weeks (post-treatment), 5-months and 12-months

Secondary outcomes (6)

  1. Students' Homework Performance - Teacher Report

    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.

    Measured: Baseline, 14-weeks (post-treatment), 5-months and 12-months

  2. Students' Homework Performance - Parent Report

    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.

    Measured: Baseline, 14-weeks (post-treatment), 5-months and 12-months

  3. Student Academic Proficiency

    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.

    Measured: Baseline, 14-weeks (post-treatment), 5-months and 12-months

  4. Student Academic Competence

    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.

    Measured: Baseline, 14-weeks (post-treatment), 5-months and 12-months

  5. Student Academic Grades

    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.

    Measured: Baseline, 5-months

  6. Student Self-efficacy

    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.

    Measured: Baseline, 14-weeks (post-treatment), 5-months and 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2018
  2. Study start8 Nov 2017
  3. Primary completion31 Mar 2023
  4. Study completion30 Sep 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03443323
Sponsor's protocol ID
17-014227
Other IDs
R305A170052-20
Status last verified
Oct 2024
First submitted
28 Nov 2017
Last updated
16 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Best JR, Miller PH, Naglieri JA. Relations between Executive Function and Academic Achievement from Ages 5 to 17 in a Large, Representative National Sample. Learn Individ Differ. 2011 Aug;21(4):327-336. doi: 10.1016/j.lindif.2011.01.007.

    PubMed 21845021

  • Best JR, Miller PH, Jones LL. Executive Functions after Age 5: Changes and Correlates. Dev Rev. 2009 Sep 1;29(3):180-200. doi: 10.1016/j.dr.2009.05.002.

    PubMed 20161467

  • Abikoff, H., & Gallagher, R. (2009). Children's organizational skills scales (COSS), technical manual. North Tonawanda, NY: Multi-Health Systems.

  • Abikoff H, Gallagher R, Wells KC, Murray DW, Huang L, Lu F, Petkova E. Remediating organizational functioning in children with ADHD: immediate and long-term effects from a randomized controlled trial. J Consult Clin Psychol. 2013 Feb;81(1):113-28. doi: 10.1037/a0029648. Epub 2012 Aug 13.

    PubMed 22889336

  • Eiraldi R, McCurdy B, Khanna M, Mautone J, Jawad AF, Power T, Cidav Z, Cacia J, Sugai G. A cluster randomized trial to evaluate external support for the implementation of positive behavioral interventions and supports by school personnel. Implement Sci. 2014 Jan 15;9:12. doi: 10.1186/1748-5908-9-12.

    PubMed 24428904

  • Langberg JM, Dvorsky MR, Evans SW. What specific facets of executive function are associated with academic functioning in youth with attention-deficit/hyperactivity disorder? J Abnorm Child Psychol. 2013 Oct;41(7):1145-59. doi: 10.1007/s10802-013-9750-z.

    PubMed 23640285

Questions about this trial

What is this clinical trial studying?

A study testing Organizational Skills Training - Tier 2 (OST-T2) in people with Executive Function and Behavioral Research, run by Children's Hospital of Philadelphia at 3 sites 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 3 inclusion and 4 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Students' Organizational Functioning - Teacher Report (time frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03443323, which also lists 6 linked publications.

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 16 Dec 2024.

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