Investigating interventions for children with ADHD
Adaptive Response to Intervention (RTI) for Students With ADHD
This study is testing different support strategies and medication options for children with ADHD in grades 1 to 5 to see which ones help them behave better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Florida International University Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT03511976 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of Tier 1 and Tier 2 interventions within a Response to Intervention (RTI) framework for children diagnosed with ADHD. The study will involve 300 children in grades 1 to 5 who are not currently on psychoactive medication and will assess the efficacy of behavioral strategies and stimulant medication for those who do not respond to initial interventions. The research will be conducted in elementary schools across Western New York and Southern Florida, utilizing a sequential multiple assignment randomized trial design to determine the best course of action for improving behavioral outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children in grades 1 to 5 who meet the DSM-V criteria for ADHD and are not currently receiving psychoactive medication.
Not a fit: Patients who have previously been successfully treated with stimulant medication or those with special education placements due to behavior problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective behavioral interventions for children with ADHD, potentially reducing the need for medication.
How similar studies have performed: Other studies have shown success with similar behavioral intervention approaches, indicating that this methodology is grounded in established practices.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Child meets DSM-V diagnostic criteria for Attention-Deficit/Hyperactivity Disorder * Child will be entering grades 1 - 5 Exclusion Criteria: * Child or sibling living in the same home has history of sustained successful treatment of ADHD with stimulant medication * Child currently has a special education placement involving placement in reduced ratio classroom or having a part or full-time aid due to behavior problems * Child has an IQ less than 70 * Child has psychosis or a pervasive developmental disorder * Child is in a classroom that already has a study participant * Child is home-schooled
Where this trial is running
Miami, Florida and 1 other locations
- Florida International University Center for Children and Families — Miami, Florida, United States (Recruiting)
- Center for Children and Families, University at Buffalo — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: William E Pelham, PhD
- Email: wpelham@fiu.edu
- Phone: 305-348-2882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.