Efficacy of an Organizational Skills Intervention for Middle School Students With ADHD
Primary Purpose
Attention-Deficit/Hyperactivity Disorder (ADHD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Homework, Organization, and Planning Skills (HOPS) Intervention
Homework Support Intervention (HSI)
Sponsored by
About this trial
This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder (ADHD) focused on measuring ADHD, Homework, School, Organization, Time-management
Eligibility Criteria
Inclusion Criteria:
- Parent consent and subject assent must be provided.
- Must be in Middle School; defined as 6-8 in the recruited schools
- Must be age: 11-15.
- Must meet DSM-IV criteria for ADHD - Predominately Inattentive Type or Combined Type.
- Must have a Full scale IQ score of greater than 80 on the WISC-IV.
- Must receive all of their core class instruction in regular education classrooms.
Exclusion Criteria:
- Diagnosis of Bipolar disorder
- Diagnosis of Psychotic disorder
- Diagnosis of a Pervasive developmental disorder
- Substance dependence
- Diagnosis of Obsessive-compulsive disorder
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HOPS Intervention
HSI Intervention
Arm Description
School counselors deliver HOPS intervention to students during the school day. This includes 16, 20-minute sessions with the student and two joint family meetings.
School counselors deliver the HSI intervention which focuses on improving focus and efficiency of work completion. This consists of 16, 20-minute sessions, with the student and two joint family meetings.
Outcomes
Primary Outcome Measures
Change in the Homework Problems Checklist Total Score from the beginning of the intervention to the end of the intervention
Parent-completed measure of homework problems related to focus and efficiency of work completion and organization of homework materials.
Secondary Outcome Measures
Change in the Children's Organizational System Scale (COSS) Total Score from the beginning of the intervention to the end of the intervention
Parent and teacher completed rating of organization, planning, and time-management skills.
Full Information
NCT ID
NCT02150668
First Posted
May 21, 2014
Last Updated
July 11, 2017
Sponsor
Virginia Commonwealth University
Collaborators
U.S. Department of Education
1. Study Identification
Unique Protocol Identification Number
NCT02150668
Brief Title
Efficacy of an Organizational Skills Intervention for Middle School Students With ADHD
Official Title
Efficacy of an Organizational Skills Intervention for Middle School Students With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
U.S. Department of Education
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed childhood disorders, with prevalence rates estimated at 8%. Several of the primary symptoms of ADHD relate to problems with temporal and materials organization (i.e. has difficulty organizing tasks and activities, loses things, is forgetful, and fails to finish school-work). In the school setting, problems with organization manifest as forgetting to complete or losing homework assignments, difficulties planning for the completion of long-term projects and studying for tests, and problems keeping class materials organized. These organizational difficulties become particularly problematic in middle school and are associated with low school grades and high parent and teacher ratings of academic impairment. In fact, organization of homework materials is one of the strongest predictors of academic performance in students with ADHD, above and beyond the impact of intelligence, school services, and ADHD medication use, and mediates the relationship between symptoms of ADHD and school grades.
Given the relationship between temporal and materials organization and poor school performance, it is clear there is a need for interventions to address these difficulties. The PI sought to address this need by completing an IES Goal 2 study to develop a school-based intervention targeting organizational skills that was feasible for school mental health (SMH) providers to implement. The Homework, Organization and Planning Skills (HOPS) intervention was developed and refined based upon input from 20 school mental health (SMH) providers, students with ADHD and their families. SMH providers implemented the HOPS intervention, rated the intervention as highly user-friendly and feasible to implement, and demonstrated excellent fidelity to intervention procedures. Students who received the HOPS intervention made significant improvements in homework problems and organizational skills compared to a waitlist control. The feasibility and fidelity data demonstrate that the intervention has potential for widespread dissemination. Preliminary outcome data suggest that the intervention may significantly improve the academic performance of students with ADHD. However, the small sample size (N=23 HOPS & N=24 control) precludes firm conclusions about efficacy and moderators and mediators of intervention response. Accordingly, the primary goal of this Goal 3 study is to evaluate the efficacy of the HOPS intervention, which focuses teaching students' organization and time-management skills, as compared to an intervention targeting on-task behaviors during homework completion and efficiency of work completion, the Homework Support Intervention (HSI), and to assess moderators and mediators of intervention response.
Middle school students with ADHD (N=260) will be randomly assigned to receive the HOPS intervention or the HSI intervention. Students in both groups will receive the same amount of intervention in terms of duration and frequency of intervention sessions. Six cohorts of students will be recruited for the project. Each cohort will consist of 22 students at each of two schools (44 per cohort) who will be randomly assigned to each of the two conditions. Objective measures of skills implementation, parent and teacher ratings of organization, homework problems, and academic impairment, and school grades will be examined pre and post intervention as well as at 8-week and 6-month follow-ups. Treatment fidelity and integrity will be closely monitored. Moderator and mediator analyses will be used to answer important questions about the types of students most likely to benefit from organizational skills intervention and the key mechanisms of change that lead to improved academic performance. This study has significant potential to improve the academic performance of students with ADHD because the intervention was designed with SMH provider input and has clear potential for widespread dissemination upon proof of efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder (ADHD)
Keywords
ADHD, Homework, School, Organization, Time-management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HOPS Intervention
Arm Type
Experimental
Arm Description
School counselors deliver HOPS intervention to students during the school day. This includes 16, 20-minute sessions with the student and two joint family meetings.
Arm Title
HSI Intervention
Arm Type
Active Comparator
Arm Description
School counselors deliver the HSI intervention which focuses on improving focus and efficiency of work completion. This consists of 16, 20-minute sessions, with the student and two joint family meetings.
Intervention Type
Behavioral
Intervention Name(s)
Homework, Organization, and Planning Skills (HOPS) Intervention
Intervention Type
Behavioral
Intervention Name(s)
Homework Support Intervention (HSI)
Primary Outcome Measure Information:
Title
Change in the Homework Problems Checklist Total Score from the beginning of the intervention to the end of the intervention
Description
Parent-completed measure of homework problems related to focus and efficiency of work completion and organization of homework materials.
Time Frame
1 academic semester (average of 4 months)
Secondary Outcome Measure Information:
Title
Change in the Children's Organizational System Scale (COSS) Total Score from the beginning of the intervention to the end of the intervention
Description
Parent and teacher completed rating of organization, planning, and time-management skills.
Time Frame
1 academic semester (average of 4 months)
Other Pre-specified Outcome Measures:
Title
Change in School Grades from the semester before the intervention to the semester after the intervention
Description
Grade point average from core classes
Time Frame
1 academic semester (average of 4 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parent consent and subject assent must be provided.
Must be in Middle School; defined as 6-8 in the recruited schools
Must be age: 11-15.
Must meet DSM-IV criteria for ADHD - Predominately Inattentive Type or Combined Type.
Must have a Full scale IQ score of greater than 80 on the WISC-IV.
Must receive all of their core class instruction in regular education classrooms.
Exclusion Criteria:
Diagnosis of Bipolar disorder
Diagnosis of Psychotic disorder
Diagnosis of a Pervasive developmental disorder
Substance dependence
Diagnosis of Obsessive-compulsive disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua M. Langberg, Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284-2018
Country
United States
12. IPD Sharing Statement
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Efficacy of an Organizational Skills Intervention for Middle School Students With ADHD
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