Efficacy of an Organizational Skills Intervention for Middle School Students With ADHD
2 other identifiers
interventional
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
May 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 13, 2017
July 1, 2017
3.8 years
May 21, 2014
July 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 academic semester (average of 4 months)
Secondary Outcomes (1)
Change in the Children's Organizational System Scale (COSS) Total Score from the beginning of the intervention to the end of the intervention
1 academic semester (average of 4 months)
Other Outcomes (1)
Change in School Grades from the semester before the intervention to the semester after the intervention
1 academic semester (average of 4 months)
Study Arms (2)
HOPS Intervention
EXPERIMENTALSchool counselors deliver HOPS intervention to students during the school day. This includes 16, 20-minute sessions with the student and two joint family meetings.
HSI Intervention
ACTIVE COMPARATORSchool 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Diagnosis of Bipolar disorder
- Diagnosis of Psychotic disorder
- Diagnosis of a Pervasive developmental disorder
- Substance dependence
- Diagnosis of Obsessive-compulsive disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virginia Commonwealth Universitylead
- U.S. Department of Educationcollaborator
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23284-2018, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua M. Langberg, Ph.D.
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2014
First Posted
May 30, 2014
Study Start
September 1, 2013
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
July 13, 2017
Record last verified: 2017-07