An interventional study of Organizational Skills Training - Tier 2 (OST-T2) in Executive Function, Behavioral Research and Schools, sponsored by Children's Hospital of Philadelphia. Completed at 3 sites in United States. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
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.
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.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's enrollment of 186 is above the median of 120 across 1,197 interventional studies indexed under Behavior.
Browse Behavior studies →Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Any student enrolled in grades 3 through 5 in one of the participating schools who meets the following criteria.
Exclusion Criteria:
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)
Strategies currently in use by schools to address organization, time management, and planning skills problems.
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.
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.
Time frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
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.
Time frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
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.
Time frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
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.
Time frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
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.
Time frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
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.
Time frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
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.
Time frame: Baseline, 5-months
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.
Time frame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
Participants were recruited from Nov., 2017 through Jan., 2022 from 22 schools serving students in upper elementary school in the Philadelphia, PA region.
| Milestone | OST-T2 Intervention Group | Treatment as Usual Wait List Control Group |
|---|---|---|
| Started | 98 | 88 |
| Baseline data | 96 | 88 |
| Completed | 95 | 86 |
| Not completed | 3 | 2 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Pi withdrawal | 1 | 0 |
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.
| scores on a scale | OST-T2 Intervention Group | Treatment as Usual Wait List Control Group |
|---|---|---|
| Baseline | 2.89 (2.80 to 2.99) | 2.86 (2.73 to 2.98) |
| Post-treatment (14 weeks) | 2.27 (2.12 to 2.41) | 2.71 (2.61 to 2.82) |
| 5-month follow-up (22 weeks) | 2.32 (2.19 to 2.45) | 2.71 (2.62 to 2.80) |
| 12-month follow-up (55 weeks) | 2.40 (2.22 to 2.59) | 2.57 (2.45 to 2.70) |
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.
| scores on a scale | OST-T2 Intervention Group | Treatment as Usual Wait List Control Group |
|---|---|---|
| Baseline | 2.65 (2.59 to 2.72) | 2.59 (2.53 to 2.64) |
| Post-Treatment (14 weeks) | 2.20 (2.09 to 2.31) | 2.51 (2.40 to 2.61) |
| 5-month follow-up (22 weeks) | 2.25 (2.14 to 2.36) | 2.53 (2.44 to 2.62) |
| 12-month follow-up (55 weeks) | 2.33 (2.17 to 2.49) | 2.35 (2.18 to 2.51) |
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.
| scores on a scale | OST-T2 Intervention Group | Treatment as Usual Wait List Control Group |
|---|---|---|
| Baseline | 1.76 (1.38 to 2.14) | 2.07 (1.64 to 2.51) |
| Post-treatment (14-weeks) | 2.68 (2.23 to 3.13) | 2.32 (2.12 to 2.53) |
| 5-month follow-up (22 weeks) | 2.55 (2.17 to 2.93) | 2.44 (2.22 to 2.66) |
| 12-month follow-up (55 weeks) | 1.97 (1.35 to 2.59) | 2.14 (1.69 to 2.60) |
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.
| scores on a scale | OST-T2 Intervention Group | Treatment as Usual Wait List Control Group |
|---|---|---|
| Baseline | 1.49 (1.35 to 1.63) | 1.35 (1.23 to 1.47) |
| Post-treatment (14 weeks) | 0.94 (0.75 to 1.14) | 1.20 (1.06 to 1.35) |
| 5-month follow-up (22 weeks) | 0.97 (0.81 to 1.12) | 1.26 (1.11 to 1.41) |
| 12-month follow-up (55 weeks) | 1.13 (0.95 to 1.32) | 1.14 (0.95 to 1.34) |
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.
| scores on a scale | OST-T2 Intervention Group | Treatment as Usual Wait List Control Group |
|---|---|---|
| Baseline | 2.59 (2.44 to 2.74) | 2.57 (2.30 to 2.84) |
| Post-treatment (14 weeks) | 2.77 (2.60 to 2.94) | 2.54 (2.40 to 2.67) |
| 5-month follow-up (22 weeks) | 2.80 (2.65 to 2.95) | 2.53 (2.44 to 2.63) |
| 12-month follow-up (55 weeks) | 2.67 (2.46 to 2.88) | 2.62 (2.34 to 2.90) |
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.
| scores on a scale | OST-T2 Intervention Group | Treatment as Usual Wait List Control Group |
|---|---|---|
| Baseline | 2.46 (2.31 to 2.62) | 2.31 (2.11 to 2.51) |
| Post-treatment (14 weeks) | 2.71 (2.55 to 2.88) | 2.35 (2.17 to 2.53) |
| 5-month follow-up (22 weeks) | 2.72 (2.57 to 2.87) | 2.46 (2.30 to 2.61) |
| 12-month follow-up (55 weeks) | 2.63 (2.42 to 2.84) | 2.42 (2.20 to 2.63) |
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.
| scores on a scale | OST-T2 Intervention Group | Treatment as Usual Wait List Control Group |
|---|---|---|
| Baseline | 2.50 (2.29 to 2.69) | 2.52 (2.32 to 2.72) |
| 5-month follow-up (22 weeks) | 2.72 (2.49 to 2.94) | 2.71 (2.52 to 2.91) |
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.
| scores on a scale | OST-T2 Intervention Group | Treatment as Usual Wait List Control Group |
|---|---|---|
| Baseline | 3.90 (3.69 to 4.10) | 3.88 (3.78 to 3.97) |
| Post-treatment (14 weeks) | 4.09 (3.89 to 4.29) | 3.98 (3.87 to 4.10) |
| 5-month follow-up (22 weeks) | 4.18 (4.03 to 4.34) | 4.08 (3.84 to 4.31) |
| 12-month follow-up (55 weeks) | 4.12 (3.75 to 4.48) | 4.22 (3.87 to 4.57) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OST-T2 Intervention Group | 0/97 (0%) | 0/97 (0%) | 0/97 (0%) |
| Treatment as Usual Control Group | 0/88 (0%) | 0/88 (0%) | 0/88 (0%) |
The PIs withdrew one participant before the study intervention period because this person was found not to meet study eligibility criteria.
| Age, Continuous(Child Age in Years) | OST-T2 Intervention Group | Treatment as Usual Control Group | Total |
|---|---|---|---|
| Mean | 9.8 ± 0.89 | 9.5 ± 0.86 | 9.7 ± 0.88 |
| Sex: Female, Male(Participants) | OST-T2 Intervention Group | Treatment as Usual Control Group | Total |
|---|---|---|---|
| Female | 31 | 32 | 63 |
| Male | 66 | 56 | 122 |
| Ethnicity (NIH/OMB)(Participants) | OST-T2 Intervention Group | Treatment as Usual Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 13 | 23 |
| Not Hispanic or Latino | 87 | 75 | 162 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | OST-T2 Intervention Group | Treatment as Usual Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 1 | 6 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 25 | 23 | 48 |
| White | 50 | 55 | 105 |
| More than one race | 11 | 8 | 19 |
| Unknown or Not Reported | 5 | 1 | 6 |
| Region of Enrollment(participants) | OST-T2 Intervention Group | Treatment as Usual Control Group | Total |
|---|---|---|---|
| United States | 97 | 88 | 185 |
| Child Grade in School(Participants) | OST-T2 Intervention Group | Treatment as Usual Control Group | Total |
|---|---|---|---|
| Grade 3 | 27 | 37 | 64 |
| Grade 4 | 46 | 32 | 78 |
| Grade 5 | 24 | 19 | 43 |
| Caregiver mean level of education(Participants) | OST-T2 Intervention Group | Treatment as Usual Control Group | Total |
|---|---|---|---|
| High School Graduate or Less | 13 | 22 | 35 |
| Partial College/Specialized Training | 30 | 36 | 66 |
| Standard College or Graduate Degree | 51 | 30 | 81 |
| Family Neighborhood Area Deprivation Index, National Percentile(Percentile) | OST-T2 Intervention Group | Treatment as Usual Control Group | Total |
|---|---|---|---|
| Mean | 39.3 ± 24.1 | 52.8 ± 23.8 | 45.7 ± 24.8 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
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@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.
Ran from Nov 2017 to primary completion in Mar 2023, 64 months.
Results were first posted in Dec 2024, 1 year 8 months after primary completion.
Of 741 non-industry interventional studies with no phase under Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's 64 months is above that.
Counting every sponsor, half of 757 studies reached it within 13 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital of Philadelphia →