Clinical trial NCT03443323: Organizational Skills Training - Tier 2 (OST-T2)
Official title: Evaluation of Organizational Skills Training (OST) Program for Upper Elementary Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Executive Function
Behavioral Research
Schools
Behavior Therapy
Keywords: Executive Function
Behavioral Research
Cost Analysis
Students
Schools
Randomized Controlled Trial
Behavior Therapy
Skills Training
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: New York University
name: U.S. Department of Education
First posted: 2018-02-23
Enrollment: 186
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

Any student enrolled in grades 3 through 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.

Primary outcomes:
measure: Students' Organizational Functioning - Teacher Report
timeFrame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
measure: Students' Organizational Functioning - Parent Report
timeFrame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
Secondary outcomes:
measure: Students' Homework Performance - Teacher Report
timeFrame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
measure: Students' Homework Performance - Parent Report
timeFrame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
measure: Student Academic Proficiency
timeFrame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
measure: Student Academic Competence
timeFrame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
measure: Student Academic Grades
timeFrame: Baseline, 5-months
measure: Student Self-efficacy
timeFrame: Baseline, 14-weeks (post-treatment), 5-months and 12-months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Thomas Power, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Jenelle Nissley-Tsiopoinis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Jennifer Mautone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Abikoff, H., & Gallagher, R. (2009). Children's organizational skills scales (COSS), technical manual. North Tonawanda, NY: Multi-Health Systems.
citation: 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.
citation: 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.
citation: 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.