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Clinical Trials/NCT03443323
NCT03443323CompletedNot Applicable

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

Children's Hospital of Philadelphia3 sites in 1 country186 target enrollmentStarted: November 8, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
186
Locations
3
Primary Endpoint
Students' Organizational Functioning - Teacher Report

Study Overview

Brief 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. 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

OST-T2 Intervention group

Experimental

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.

Intervention: Organizational Skills Training - Tier 2 (OST-T2) (Behavioral)

Treatment as usual control group

No Intervention

Strategies currently in use by schools to address organization, time management, and planning skills problems.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Students' Homework Performance - Teacher Report(Baseline, 14-weeks (post-treatment), 5-months and 12-months)
  • Students' Homework Performance - Parent Report(Baseline, 14-weeks (post-treatment), 5-months and 12-months)
  • Student Academic Proficiency(Baseline, 14-weeks (post-treatment), 5-months and 12-months)
  • Student Academic Competence(Baseline, 14-weeks (post-treatment), 5-months and 12-months)
  • Student Academic Grades(Baseline, 5-months)
  • Student Self-efficacy(Baseline, 14-weeks (post-treatment), 5-months and 12-months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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