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Clinical Trial 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 at least 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.


Clinical Trial 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 at least 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03443323
Study type Interventional
Source Children's Hospital of Philadelphia
Contact
Status Completed
Phase N/A
Start date November 8, 2017
Completion date March 31, 2023

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