Attention-Deficit/Hyperactivity Disorder (ADHD) Clinical Trial
Official title:
Efficacy of an Organizational Skills Intervention for Middle School Students With ADHD
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00631280 -
Does Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD
|
N/A | |
Recruiting |
NCT05809388 -
Virtual Reality for Parent Training Intervention
|
N/A | |
Completed |
NCT00776009 -
Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.
|
Phase 4 | |
Recruiting |
NCT00252278 -
Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents
|
Phase 4 | |
Completed |
NCT04016779 -
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
|
Phase 3 | |
Completed |
NCT00307268 -
Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD
|
N/A | |
Completed |
NCT01107496 -
Evaluation of Immediate-Release Viloxazine in Adults With ADHD
|
Phase 1/Phase 2 | |
Completed |
NCT04786990 -
Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD
|
Phase 4 | |
Completed |
NCT00475735 -
A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)
|
Phase 2 | |
Completed |
NCT00711724 -
Comparison of Self and Clinician Administered Rating Scales in Patients With ADHD
|
N/A | |
Recruiting |
NCT06215144 -
Study to Evaluate NRCT-101SR in Pediatric Subjects With ADHD
|
Phase 2/Phase 3 | |
Completed |
NCT02633527 -
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
|
Phase 2 | |
Withdrawn |
NCT00323700 -
A Naturalistic Prospective Study of Treatment Effectiveness for Attention-Deficit/Hyperactivity Disorder (ADHD)
|
N/A | |
Not yet recruiting |
NCT04532190 -
Finding Alternatives to Standard Treatment for Attention-Deficit Hyperactivity Disorder
|
N/A | |
Withdrawn |
NCT00931398 -
Treatment of College Students With Attention-Deficit/Hyperactivity Disorder (ADHD) Using OROS Methylphenidate
|
Phase 4 |