Adaptive Response to Intervention (RTI) for Students With ADHD
Purpose: The primary purpose of the proposed project is to investigate the efficacy of Tier 1 and Tier 2 interventions delivered through a Response to Intervention (RTI) framework for children with attention-deficit/hyperactivity disorder (ADHD). Further, for children who do not respond to initial Tier 2 strategies, the proposed study will assess which additional course of intervention is most effective: (1) enhanced Tier 2 strategies or (2) stimulant medication. The majority of youth with ADHD are in general education settings, whether classified as special education students or not. Thus, experimentally evaluating the efficacy of well-developed and evidence-based behavioral interventions within a problem-solving framework such as RTI would significantly inform practice within school-based behavioral intervention teams. Project Activities: This study will employ a sequential multiple assignment randomized trial design (SMART). Prior to the beginning of the academic year, students will be randomly assigned to one of two conditions: (1) Business as Usual in which children receive whatever sequence of academic supports and interventions their teachers, school, and parents would typically put into place throughout the entire academic year and (2) an RTI approach to begin with Tier 1 classroom-wide management strategies with opportunities to add Tier 2 strategies for youth who do not respond to the initial Tier 1 approach.
Conditions:
🦠 Attention Deficit Disorder With Hyperactivity
🗓️ Study Start (Actual) 14 May 2018
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 300
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Miami, Florida, United States
📍 Buffalo, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 April 2018
  • First Submitted that Met QC Criteria 18 April 2018
  • First Posted 30 April 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 September 2023
  • Last Update Posted 8 September 2023
  • Last Verified September 2023