Executive Function Clinical Trial
Official title:
Evaluation of Organizational Skills Training (OST) Program for Upper Elementary Students
Verified date | June 2023 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 381 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Any student enrolled in grades 3 thru 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. |
Country | Name | City | State |
---|---|---|---|
United States | New York University | New York | New York |
United States | Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | New York University, U.S. Department of Education, University of Pennsylvania |
United States,
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. — View Citation
Abikoff, H., & Gallagher, R. (2009). Children's organizational skills scales (COSS), technical manual. North Tonawanda, NY: Multi-Health Systems.
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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Students' Organizational Functioning | The Children's Organizational Skills Scales (COSS) will be 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). Although the COSS yields three subscale scores, only the total score will be used to reduce the number of measures in the analyses. | Baseline, 10-weeks (post-treatment), 5-months and 12-months | |
Primary | Changes in Students' Patterns of Adaptive Learning | Patterns of Adaptive Learning Scales (PALS) will be used to evaluate changes in students' perceptions of their competence in completing their classwork. Items are rated on a 5-item scale from 1 = not at all true to 5 = very true. | Baseline, 10-weeks (post-treatment), 5-months and 12-months | |
Secondary | Changes in Student's Academic Progress | The Academic Progress Report (APR) is a teacher-report measure that assesses (changes in) proficiency in seven academic subjects relative to standard expectations (1=Well below standard expected at this time of year; 3=At standard; 5=Well above standard). The sum of ratings across seven academic subjects is the unit of analysis. Reliability is acceptable (alpha = .84), and this measure is sensitive to OST treatment effects. | Baseline, 10-weeks (post-treatment), 5-months and 12-months | |
Secondary | Changes in Academic Competence of Students | 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 will be used. Alpha coefficients and test-retest correlations for these subscales have been shown to be above .90. The average of these subscale scores will be used in the analyses. | Baseline, 10-weeks (post-treatment), 5-months and 12-months | |
Secondary | Academic Grades of Students | Student report card grades for the marking period prior to students' participation in OST-S/TAU and for the marking period immediately after the intervention and follow-up periods. For students enrolled before the first marking period is over, baseline grades will be those obtained at the end of the previous school year. | Baseline, 10-weeks (post-treatment), 5-months and 12-months | |
Secondary | Students' Homework Performance | The Homework Performance Questionnaire (HPQ-T)-Teacher version will be used to assess changes in students' homework behavior during the past 4 weeks. Each item is rated on a five-point scale. The 9-item Student Self-Regulation factor will be used in the analyses. This factor has been demonstrated to have strong psychometric properties. | Baseline, 10-weeks (post-treatment), 5-months and 12-months | |
Secondary | Parent's Report of Changes in their Child's Homework Performance | The Homework Problem Checklist (HPC) is a 20-item parent-report measure that will be used to assess changes in student homework performance. 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 will be used in the analyses. | Baseline, 10-weeks (post-treatment), 5-months and 12-months | |
Secondary | Changes in Participants' views of Treatment Acceptability | Measures of Acceptability of OST-S will be assessed using the following measure:
The Treatment Evaluation Inventory - Short Form (TEI-SF), a 9-item measure, will be used to assess parents' views of treatment acceptability. |
up to 10-weeks (post treatment) | |
Secondary | Changes in Participants' views of Treatment Usability | The Usage Rating Profile-Intervention-Revised (URP-IR), a 29-item measure, will be adapted (with permission) to assess factors that may influence the usage of the OST-S intervention in a school-based setting. | up to 10-weeks (post treatment) | |
Secondary | Changes in Participants' Views of Treatment Feasibility | The Usage Rating Profile-Intervention-Revised (URP-IR), a 29-item measure, will be adapted (with permission) to assess feasibility of usage of the OST-S intervention in a school-based setting. | up to 10-weeks (post treatment) | |
Secondary | Changes in Participants' Views of Treatment Acceptability | The Children's Intervention Rating Profile (CIRP), a 7-item measure, will be adapted to assess student's perceptions of acceptability. | up to 10-weeks (post treatment) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06038435 -
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
|
N/A | |
Completed |
NCT01365897 -
Effectiveness of Modafinil in Improving Cognitive Performance of University Students
|
Phase 4 | |
Active, not recruiting |
NCT00747396 -
The Bucharest Early Intervention Project
|
N/A | |
Not yet recruiting |
NCT05513339 -
Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows
|
||
Completed |
NCT03003286 -
Community Based Intervention for Children With ADHD and ASD
|
N/A | |
Not yet recruiting |
NCT05468216 -
Movement Integration in Primary Schools' Lessons
|
N/A | |
Completed |
NCT04082247 -
Healthy Children 2021 Study in Childcare Centers
|
N/A | |
Not yet recruiting |
NCT03946254 -
Effect of Strength Training on Executive Functions in Elderly People With Mild Cognitive Impairment
|
N/A | |
Completed |
NCT03800030 -
Effect of Cross Frequency tACS on Cognitive Control
|
N/A | |
Recruiting |
NCT04989712 -
MOReS Freestyle Libre Validation Study
|
N/A | |
Active, not recruiting |
NCT05290584 -
Influence of Preschool Children's Fundamental Movement Skills, Physical Activity, and Physical Fitness on Executive Function: A Prospective Observation Study
|
||
Recruiting |
NCT06175897 -
Effects of STN DBS on Cognition and Brain Networks in PD Patients Analyzed Based on EEG and fNIRS
|
N/A | |
Not yet recruiting |
NCT04103463 -
Interactive Stepping Exercise on Memory
|
N/A | |
Completed |
NCT04329663 -
Effectiveness of the Indonesian Computer-based Game
|
N/A | |
Not yet recruiting |
NCT01718405 -
Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function
|
N/A | |
Recruiting |
NCT06241300 -
Executive Function and Parenting in Childhood
|
N/A | |
Completed |
NCT05910632 -
Eccentrically Reinforced Resistance Training vs. Traditional Resistance Training in Sedentary Older Women
|
N/A | |
Completed |
NCT05462977 -
Rhythmically Entrained Exercise in Community-Dwelling Older Adults
|
N/A | |
Recruiting |
NCT06436209 -
Cognitive Control & the Functional Organization of the Frontal Cortex
|
N/A | |
Not yet recruiting |
NCT06286943 -
The Effects of Short-Chain Fatty Acids in Psychosocial Stress-Induced Impairment on Core Executive Functions
|
N/A |