NCT03443323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 16, 2024

Completed
Last Updated

December 16, 2024

Status Verified

October 1, 2024

Enrollment Period

5.4 years

First QC Date

November 28, 2017

Results QC Date

March 21, 2024

Last Update Submit

October 29, 2024

Conditions

Keywords

Executive FunctionBehavioral ResearchCost AnalysisStudentsSchoolsRandomized Controlled TrialBehavior TherapySkills Training

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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.

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

Treatment as usual control group

NO INTERVENTION

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

Interventions

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.

OST-T2 Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

New York University

New York, New York, 10016, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (6)

  • 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.

    PMID: 21845021BACKGROUND
  • 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.

    PMID: 20161467BACKGROUND
  • Abikoff, H., & Gallagher, R. (2009). Children's organizational skills scales (COSS), technical manual. North Tonawanda, NY: Multi-Health Systems.

    BACKGROUND
  • 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.

    PMID: 22889336BACKGROUND
  • 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.

    PMID: 24428904BACKGROUND
  • 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.

    PMID: 23640285BACKGROUND

Limitations and Caveats

Findings are generalizable to schools for which OST-T2 was viewed as aligned with school mission, feasible to deliver, and could be implemented by a school professional. Children identified as Black or White were overrepresented; those identified as Hispanic/Latino were underrepresented. Schools serving a high proportion of children living in poverty/deep poverty were underrepresented. COVID-19 resulted in participation challenges that limited the final sample size.

Results Point of Contact

Title
Dr. Thomas J. Power
Organization
Children's Hospital of Philadelphia

Study Officials

  • Thomas Power, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
  • Jenelle Nissley-Tsiopoinis, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
  • Jennifer Mautone, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2017

First Posted

February 23, 2018

Study Start

November 8, 2017

Primary Completion

March 31, 2023

Study Completion

September 30, 2023

Last Updated

December 16, 2024

Results First Posted

December 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
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.

Locations