Efficacy of an Organizational Skills Intervention for Middle School Students With ADHD

Attention-Deficit/Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

Efficacy of an Organizational Skills Intervention for Middle School Students With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150668
• Other study ID #: HM14899
• Secondary ID: R305A130011
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: July 11, 2017
• Start date: September 2013
• Est. completion date: June 1, 2017

Study information

• Verified date: July 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder (ADHD)

Intervention

Behavioral:
• Homework, Organization, and Planning Skills (HOPS) Intervention

• Homework Support Intervention (HSI)

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in School Grades from the semester before the intervention to the semester after the intervention	Grade point average from core classes	1 academic semester (average of 4 months)
Primary	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	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.	1 academic semester (average of 4 months)