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HOPS Study: A Conceptual Replication

Primary Purpose

Executive Dysfunction, Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Homework, Organization, and Planning Skills
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Executive Dysfunction

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or female students in grades 6 through 8.
  2. Student is in a general education classroom.
  3. Student is nominated for the study by at least one academic teacher who reports regularly assigning homework to this student.
  4. Nominating teacher(s) rates the student's OTMP skills deficits as having a negative impact on academic performance (rating > 3 on a 4-point scale on at least one of four interference items of COSS-T),
  5. Parental/guardian permission (informed consent) and student assent.

Exclusion Criteria:

  1. Students will be excluded if they are in a pull-out special education classroom for more than 50% of the day, because the organizational demands for these students may differ from those 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. Students from a family in which one student has already been enrolled in the study will be excluded. Only one student per family will be included in the study.

Sites / Locations

  • Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Homework, Organization, and Planning Skills (HOPS)

Treatment-As-Usual Waitlist (WL-TAU)

Arm Description

The Homework, Organization, and Planning Skills (HOPS) intervention is delivered through a series of 16 frequent but brief sessions between the HOPS provider and student. The HOPS intervention will be delivered by either a member of the school team (HOPS-ST), referred to as a "school provider", or a member of the research team (HOPS-RT), referred to as a "research provider". Each session is approximately 20 minutes. The three main skill areas covered as part of the program are: (1) school materials organization, (2) homework management and (3) time management and planning. A reward system is utilized in effort to change behavior patterns by making rewards available when a student engages in productive organizing and planning behaviors. The intervention also includes two parent meetings and one teacher meeting.

The Treatment-As-Usual Waitlist (WL-TAU) will be enacted for study participants attending the enrolled schools assigned to this arm. After providing post data (and in some cases, follow-up data as well), participants will then receive the HOPS intervention.

Outcomes

Primary Outcome Measures

Change in Student Functioning at Home
The Children's Organizational Skills Scale - Parent version (COSS-P) will be used to assess changes in OTMP functioning at home. COSS-P total scores have good discriminant validity and are sensitive to treatment effects. The COSS-P uses a 4-point rating scale (1=Hardly ever or never to 4=Just about all of the time). The COSS-P yields three subscale scores: Materials Management, Organized Actions, and Task Planning. Minimum scores for each subscale and the Total score are 40 and maximum scores are 90, with higher scores representing more impairment. The COSS-P will be used primarily as an outcome measure. In addition, Investigators will examine whether severity of organization problems, as measured by Baseline COSS-P scores, moderates the effect of treatment on academic outcomes.
Change in Student Functioning at School
The Children's Organizational Skills Scale - Teacher version (COSS-T) will be used to assess changes in OTMP functioning at school. COSS total scores have good discriminant validity and are sensitive to treatment effects. The COSS-T uses a 4-point rating scale (1=Hardly ever or never to 4=Just about all of the time). The COSS-T yields three subscale scores: Materials Management, Organized Actions, and Task Planning. Minimum scores for each subscale and the Total score are 40 and maximum scores are 90, with higher scores representing more impairment. The COSS-T will be used primarily as an outcome measure. In addition, Investigators will examine whether severity of organization problems, as measured by Baseline COSS-T scores, moderates the effect of treatment on academic outcomes.

Secondary Outcome Measures

Change in Student Proficiency in Academic Subject Areas
The Academic Progress Report (APR) is a teacher-report measure that assesses proficiency in up to six 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 six academic subjects is the unit of analysis. The minimum score is 1 and the maximum score is 5, with higher scores indicating higher functioning. Reliability is acceptable (alpha = .84), and this measure is sensitive to treatment effects for an elementary school organizational skills training intervention. For each participating student, Investigators will obtain teacher ratings on the APR from two of the student's academic teachers to attempt to capture the student's academic performance in a standardized fashion.
Change in Student Academic Grades
Investigators will obtain report card grades for the academic year prior to student enrollment, the academic year of student enrollment, and the academic year following student enrollment for all participating students. Investigators will calculate students' grade point average based on report card grades.
Change in Student Homework Performance at Home
The Homework Problem Checklist (HPC) is a 20-item parent-report measure that assesses student homework performance. Factor analyses conducted by Power and Langberg et al., have indicated that the HPC has two distinct factors: Homework Completion and Homework Materials Management. Scores range from a minimum of 0 to a maximum of 60, with higher scores representing higher impairment. The HPC has been shown to be sensitive to the effects of interventions to improve student homework and organization skills.
Change in Student Homework Competence at School
The Homework Performance Questionnaire - Teacher Revised Version (HPQ-T) assesses students' homework behavior during the past 4 weeks. Each item is rated on a 7-point scale indicating how often each behavior occurs (never or rarely = 0% to 10% of time; almost always/always = 91% to 100% of time). The 17-item General factor that assesses overall homework competence, which has strong psychometric properties, will be used in the analyses. This score is generated by averaging the scores of items 9-25, with a minimum score of 0 and a maximum score of 6. Higher scores indicate higher functioning.

Full Information

First Posted
June 30, 2020
Last Updated
February 27, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, Virginia Commonwealth University, U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT04465708
Brief Title
HOPS Study: A Conceptual Replication
Official Title
Evaluation of Homework, Organization, and Planning Skills (HOPS) Program: A Conceptual Replication
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
January 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, Virginia Commonwealth University, U.S. Department of Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this current study is to conduct a conceptual replication with an independent evaluation team of the randomized controlled trial conducted by Langberg and colleagues, which demonstrated the efficacy of the Homework, Organization, and Planning Skills (HOPS) intervention. The study will be conducted under routine practice conditions with school staff serving as interventionists; the study sample will include the broad range of students with organization, time management, and planning problems. The study will examine how implementation factors (fidelity, engagement, working alliance) are related to outcomes, and it will explore the potential moderating role of school organization factors on outcomes.
Detailed Description
Organization, time management, and planning (OTMP) skills are associated with academic performance. A randomized controlled trial found that the Homework, Organization, and Planning Skills (HOPS) intervention was effective in improving student organization skills and homework performance, with moderate to large effect sizes. HOPS is a 16-session skills training program, provided individually to students in grades 6 through 8 who have OTMP skills deficits that contribute to academic difficulties. Two parent consultations and one teacher consultation promote generalization and maintenance of effects. The current study is a conceptual replication of the previous HOPS study, conducted by an independent evaluation team. The intervention will be delivered under routine practice conditions, with school staff serving as interventionists. The study will examine how fidelity, engagement, and working alliance are related to outcomes, and it will explore the extent to which school organization factors moderate outcomes. Across 30 schools in Pennsylvania and New Jersey, Investigators will recruit a total of 240 6th, 7th, and 8th grade students with OTMP deficits. Parents and teachers provide data about the students. School counselors, Principals, and an Individualized Education Plan (IEP)/504 Plan Case Manager may provide data about the organizational context of the schools. The intervention is provided individually to students by a member of the school staff or a member of the research team. Using a cluster randomized design, Investigators will randomize schools to HOPS or Treatment as Usual - Wait List (TAU-WL), ratio of 2:1. In HOPS schools, students will be randomly assigned to receive intervention by school providers (HOPS-ST) or by research team providers (HOPS-RT). Outcomes will be assessed at Baseline and Post-Treatment for all students, 5 months after Baseline assessment for all HOPS students and 6th and 7th grade TAU-WL students, and 12 months after Baseline for students in grades 6 and 7 who received HOPS. Participants in TAU-WL will receive HOPS following completion of study activities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Executive Dysfunction, Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Homework, Organization, and Planning Skills (HOPS)
Arm Type
Other
Arm Description
The Homework, Organization, and Planning Skills (HOPS) intervention is delivered through a series of 16 frequent but brief sessions between the HOPS provider and student. The HOPS intervention will be delivered by either a member of the school team (HOPS-ST), referred to as a "school provider", or a member of the research team (HOPS-RT), referred to as a "research provider". Each session is approximately 20 minutes. The three main skill areas covered as part of the program are: (1) school materials organization, (2) homework management and (3) time management and planning. A reward system is utilized in effort to change behavior patterns by making rewards available when a student engages in productive organizing and planning behaviors. The intervention also includes two parent meetings and one teacher meeting.
Arm Title
Treatment-As-Usual Waitlist (WL-TAU)
Arm Type
No Intervention
Arm Description
The Treatment-As-Usual Waitlist (WL-TAU) will be enacted for study participants attending the enrolled schools assigned to this arm. After providing post data (and in some cases, follow-up data as well), participants will then receive the HOPS intervention.
Intervention Type
Behavioral
Intervention Name(s)
Homework, Organization, and Planning Skills
Other Intervention Name(s)
HOPS
Intervention Description
HOPS is a 16-session, skills training program, provided individually to students in grades 6 through 8 who have OTMP skills deficits that contribute to academic difficulties. HOPS includes two parent consultations and one teacher consultation to promote generalization and maintenance of effects.
Primary Outcome Measure Information:
Title
Change in Student Functioning at Home
Description
The Children's Organizational Skills Scale - Parent version (COSS-P) will be used to assess changes in OTMP functioning at home. COSS-P total scores have good discriminant validity and are sensitive to treatment effects. The COSS-P uses a 4-point rating scale (1=Hardly ever or never to 4=Just about all of the time). The COSS-P yields three subscale scores: Materials Management, Organized Actions, and Task Planning. Minimum scores for each subscale and the Total score are 40 and maximum scores are 90, with higher scores representing more impairment. The COSS-P will be used primarily as an outcome measure. In addition, Investigators will examine whether severity of organization problems, as measured by Baseline COSS-P scores, moderates the effect of treatment on academic outcomes.
Time Frame
Baseline, 3 Months after Baseline, 5 Months after Baseline, 12 Months after Baseline
Title
Change in Student Functioning at School
Description
The Children's Organizational Skills Scale - Teacher version (COSS-T) will be used to assess changes in OTMP functioning at school. COSS total scores have good discriminant validity and are sensitive to treatment effects. The COSS-T uses a 4-point rating scale (1=Hardly ever or never to 4=Just about all of the time). The COSS-T yields three subscale scores: Materials Management, Organized Actions, and Task Planning. Minimum scores for each subscale and the Total score are 40 and maximum scores are 90, with higher scores representing more impairment. The COSS-T will be used primarily as an outcome measure. In addition, Investigators will examine whether severity of organization problems, as measured by Baseline COSS-T scores, moderates the effect of treatment on academic outcomes.
Time Frame
Baseline, 3 Months after Baseline, 5 Months after Baseline, 12 Months after Baseline
Secondary Outcome Measure Information:
Title
Change in Student Proficiency in Academic Subject Areas
Description
The Academic Progress Report (APR) is a teacher-report measure that assesses proficiency in up to six 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 six academic subjects is the unit of analysis. The minimum score is 1 and the maximum score is 5, with higher scores indicating higher functioning. Reliability is acceptable (alpha = .84), and this measure is sensitive to treatment effects for an elementary school organizational skills training intervention. For each participating student, Investigators will obtain teacher ratings on the APR from two of the student's academic teachers to attempt to capture the student's academic performance in a standardized fashion.
Time Frame
Baseline, 3 Months after Baseline, 5 Months after Baseline, 12 Months after Baseline
Title
Change in Student Academic Grades
Description
Investigators will obtain report card grades for the academic year prior to student enrollment, the academic year of student enrollment, and the academic year following student enrollment for all participating students. Investigators will calculate students' grade point average based on report card grades.
Time Frame
Baseline, 3 Months after Baseline, 5 Months after Baseline, 12 Months after Baseline
Title
Change in Student Homework Performance at Home
Description
The Homework Problem Checklist (HPC) is a 20-item parent-report measure that assesses student homework performance. Factor analyses conducted by Power and Langberg et al., have indicated that the HPC has two distinct factors: Homework Completion and Homework Materials Management. Scores range from a minimum of 0 to a maximum of 60, with higher scores representing higher impairment. The HPC has been shown to be sensitive to the effects of interventions to improve student homework and organization skills.
Time Frame
Baseline, 3 Months after Baseline, 5 Months after Baseline, 12 Months after Baseline
Title
Change in Student Homework Competence at School
Description
The Homework Performance Questionnaire - Teacher Revised Version (HPQ-T) assesses students' homework behavior during the past 4 weeks. Each item is rated on a 7-point scale indicating how often each behavior occurs (never or rarely = 0% to 10% of time; almost always/always = 91% to 100% of time). The 17-item General factor that assesses overall homework competence, which has strong psychometric properties, will be used in the analyses. This score is generated by averaging the scores of items 9-25, with a minimum score of 0 and a maximum score of 6. Higher scores indicate higher functioning.
Time Frame
Baseline, 3 Months after Baseline, 5 Months after Baseline, 12 Months after Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female students in grades 6 through 8. Student is in a general education classroom. Student is nominated for the study by at least one academic teacher who reports regularly assigning homework to this student. Nominating teacher(s) rates the student's OTMP skills deficits as having a negative impact on academic performance (rating > 3 on a 4-point scale on at least one of four interference items of COSS-T), Parental/guardian permission (informed consent) and student assent. Exclusion Criteria: Students will be excluded if they are in a pull-out special education classroom for more than 50% of the day, because the organizational demands for these students may differ from those 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. Students from a family in which one student has already been enrolled in the study will be excluded. Only one student per family will be included in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phylicia Fleming
Phone
267-542-2534
Email
flemingp@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jaclyn Cacia
Phone
(267) 426-6015
Email
caciaj@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Power, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jenelle Nissley-Tsiopinis, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Power, PhD
Email
power@chop.edu
First Name & Middle Initial & Last Name & Degree
Jenelle Nissley-Tsiopinis, PhD
Email
nissleyj@chop.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24319323
Citation
Langberg JM, Becker SP, Epstein JN, Vaughn AJ, Girio-Herrera E. Predictors of Response and Mechanisms of Change in an Organizational Skills Intervention for Students with ADHD. J Child Fam Stud. 2013 Oct 1;22(6):10.1007/s10826-012-9662-5. doi: 10.1007/s10826-012-9662-5.
Results Reference
background
PubMed Identifier
29172596
Citation
Langberg JM, Dvorsky MR, Molitor SJ, Bourchtein E, Eddy LD, Smith ZR, Oddo LE, Eadeh HM. Overcoming the research-to-practice gap: A randomized trial with two brief homework and organization interventions for students with ADHD as implemented by school mental health providers. J Consult Clin Psychol. 2018 Jan;86(1):39-55. doi: 10.1037/ccp0000265. Epub 2017 Nov 27.
Results Reference
background
PubMed Identifier
22889336
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.
Results Reference
background
PubMed Identifier
23506023
Citation
Pfiffner LJ, Villodas M, Kaiser N, Rooney M, McBurnett K. Educational outcomes of a collaborative school-home behavioral intervention for ADHD. Sch Psychol Q. 2013 Mar;28(1):25-36. doi: 10.1037/spq0000016.
Results Reference
background
PubMed Identifier
21544228
Citation
Langberg JM, Arnold LE, Flowers AM, Altaye M, Epstein JN, Molina BS. Assessing Homework Problems in Children with ADHD: Validation of a Parent-Report Measure and Evaluation of Homework Performance Patterns. School Ment Health. 2010 Mar 1;2(1):3-12. doi: 10.1007/s12310-009-9021-x.
Results Reference
background
PubMed Identifier
22506793
Citation
Power TJ, Mautone JA, Soffer SL, Clarke AT, Marshall SA, Sharman J, Blum NJ, Glanzman M, Elia J, Jawad AF. A family-school intervention for children with ADHD: results of a randomized clinical trial. J Consult Clin Psychol. 2012 Aug;80(4):611-23. doi: 10.1037/a0028188. Epub 2012 Apr 16.
Results Reference
background

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HOPS Study: A Conceptual Replication

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