Study Stopped
Death of PI
Adaptive Response to Intervention (RTI) for Students With ADHD
1 other identifier
interventional
N/A
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2018
Longer than P75 for phase_4
2 active sites
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
First Submitted
Initial submission to the registry
April 18, 2018
CompletedFirst Posted
Study publicly available on registry
April 30, 2018
CompletedStudy Start
First participant enrolled
May 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2023
CompletedAugust 7, 2025
August 1, 2025
5.4 years
April 18, 2018
August 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Observations of Classroom Behavior
Independent observations will be conducted using the Student-Behavior Teacher-Response observation system (SBTR; Pelham, Greiner, \& Gnagy, 2008; Vujnovic, Fabiano et al., 2014). The SBTR is an observation code that collects information on: (1) the frequency of student rule violations; (2) whether a teacher observed the misbehavior; (3) if observed, whether the teacher enacted a consequence and whether it was an appropriate consequence. The SBTR system also records the number of praise statements and commands issued. The SBTR is a well-defined and validated observation system for use with children with ADHD in classroom settings. The SBTR system documents child functioning across a number of disruptive behavior categories (e.g., be respectful, obey adults, work quietly, stay on task), and it is consistent with an evidence-based assessment procedure for ADHD (Pelham, Fabiano, \& Massetti, 2005).
End of academic year 1 of enrollment
Secondary Outcomes (2)
Disruptive Behavior Disorders Rating Scale
End of academic year 1 of enrollment
Impairment Rating Scale
End of academic year 1 of enrollment
Study Arms (5)
Business as Usual (BAU)
NO INTERVENTIONOne-third of participants will be assigned to this condition and will receive academic accommodations and interventions as deemed appropriate by their teachers, school personnel, and parents. This condition is intended to mirror current standard procedures for youth with ADHD. Thus, the specific accommodations and interventions are expected to vary across students. Some students' parents and physicians may choose to start stimulant medication with a goal of improving classroom performance.
Response to Intervention (RTI): Tier 1
EXPERIMENTALTwo-thirds of participants will be assigned to the RTI Tier 1 Arm. Teachers of students in this arm will receive consultation in RTI Tier 1 Classroom Management strategies.
RTI: Daily Report Card (DRC)
EXPERIMENTALStudents assigned to the RTI Tier 1 Arm, who do not respond to the initial RTI Tier 1 Classroom Management strategies, will move to the RTI DRC Arm of the study. Teachers of students in this arm of the study will receive consultation to implement a daily report card.
RTI: Enhanced
EXPERIMENTALHalf of students in the RTI DRC Arm who do not respond to the DRC intervention will be randomly assigned to the RTI: Enhanced Arm. Students in this arm will receive a more intensive classroom behavioral intervention directed at individual target behaviors through an enhanced DRC.
Medication
EXPERIMENTALHalf of students in the RTI DRC Arm who do not respond to the DRC intervention will be randomly assigned to the Medication arm and will receive stimulant medication as an additional intervention.
Interventions
The primary teacher for each participating student will receive consultation related to implementing Tier I management strategies at a classroom level for all students including the target child (see Appendix C). Consultation will be provided by trained study personnel and the strategies will be implemented by the general education teacher (i.e., the end user of the intervention)
Students in the RTI DRC condition will receive Tier II strategies, namely an individualized DRC. Behavioral consultants will meet with teachers to identify appropriate behavioral targets and establish a DRC according to established protocol (see our website for an example http://ccf.fiu.edu/for-families/resources-for-parents/printable- information/). Consultants will also meet with parents to develop a plan for reinforcing the DRC at home using a hierarchical menu of rewards/privileges that will be provided contingent on meeting daily goals.
In this condition, students who did not show sufficient response to the Phase 1 DRC will receive additional and more intensive Tier II supports. Following student assignment to RTI-E, the teacher will have meet with one of the consultants to complete a functional behavior analysis (FBA) to identify remaining target behaviors and ascertain their function. The consultant and teacher will then use the completed FBA to develop a treatment plan for an enhanced DRC (DRC-E). Tier II enhancements will be chosen to directly map on to the functions of the target behaviors as outlined in the FBA.
Students will receive either a long-acting methylphenidate preparation or a long-acting mixed amphetamine salts preparation based on parent consultation with the study physician. The prescribed medication will be taken daily.
Eligibility Criteria
You may qualify if:
- Child meets DSM-V diagnostic criteria for Attention-Deficit/Hyperactivity Disorder
- Child will be entering grades 1 - 5
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florida International Universitylead
- University at Buffalocollaborator
Study Sites (2)
Florida International University Center for Children and Families
Miami, Florida, 33199, United States
Center for Children and Families, University at Buffalo
Buffalo, New York, 14214, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2018
First Posted
April 30, 2018
Study Start
May 14, 2018
Primary Completion
October 21, 2023
Study Completion
October 21, 2023
Last Updated
August 7, 2025
Record last verified: 2025-08