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Adaptive Response to Intervention (RTI) for Students With ADHD

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tier 1 Classroom Management
Daily Report Card (DRC)
Enhanced DRC (DRC-E)
Stimulant
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida International University Center for Children and FamiliesRecruiting
  • Center for Children and Families, University at BuffaloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Business as Usual (BAU)

Response to Intervention (RTI): Tier 1

RTI: Daily Report Card (DRC)

RTI: Enhanced

Medication

Arm Description

One-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.

Two-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.

Students 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.

Half 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.

Half 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Disruptive Behavior Disorders Rating Scale
Teachers will complete ratings of student classroom behavior
Impairment Rating Scale
Teacher rating of student impairment

Full Information

First Posted
April 18, 2018
Last Updated
September 6, 2023
Sponsor
Florida International University
Collaborators
University at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT03511976
Brief Title
Adaptive Response to Intervention (RTI) for Students With ADHD
Official Title
Adaptive Response to Intervention (RTI) for Students With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
Collaborators
University at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Setting: The proposed investigation will be conducted in elementary schools throughout the Western New York and Southern Florida areas. Sample: Participants will be 300 children, grades 1 - 5, with ADHD who have not been classified as special education students (e.g., Specific learning Disability, Emotional Disturbed, Other Health Impaired), who are not currently prescribed psychoactive medication and are naïve to psychoactive medication. Half of the participants will be recruited in Florida and half will be recruited in New York. This sample is selected to represent school-age children with ADHD who are at elevated risk for referral for special education services. Intervention: The intervention under study will be a RTI approach for child behavior. The entire intervention includes Tier 1 classwide-behavioral management strategies used by the teacher, a Daily Report Card (DRC) that targets the child's behaviors needed to promote successful social and academic outcomes, and if needed, an enhanced RTI. Participants assigned to the enhanced RTI arm will receive a DRC enhanced with additional behavior management strategies (e.g., differential attention, delayed punishments to reduce escape-maintained behaviors, premack contingencies, etc.) targeting behaviors as indicated by a functional behavior analysis. Participants assigned to the stimulant medication condition will continue to receive the DRC established previously and will also receive stimulant medication during the school day. Research Design and Methods: One-third of children will be allocated to the BAU condition and two-thirds will be allocated to the RTI approach (Phase 1 Randomization). Children assigned to the RTI approach who do not respond to the Tier 1 strategies will receive a Tier 2 intervention, namely a daily report card (DRC; Phase 2). Children who demonstrate non-response to the DRC will be randomly assigned to one of two additional treatment arms: (1) enhanced RTI (RTI-E) or (2) stimulant medication (Phase 3 Randomization). Children will be allocated evenly across these two conditions. Control Condition: The RTI framework will be compared with other alternative intervention approaches that represent the standard of care for ADHD treatment in schools (i.e., medication, business as usual classroom intervention) to determine whether this specific model/framework of intervention is efficacious relative to an ecologically valid, counter-factual, comparison group. Key Measures: Measures of key outcomes will include risk of referral to special education as measured by functional academic outcomes, observations of behavior in the classroom by observers unaware of study hypothesis or treatment condition, and parent and teacher ratings of functioning. Secondary outcome measures will include potential mediators and moderators of treatment response including: discipline referrals, parent contacts due to problems in academic or behavioral functioning, teacher adherence to Tier 1 and Tier 2 strategies, and referrals for an IEP or 504 plan. Data Analytic Strategy: Specific aims will be addressed using primary data analysis strategies for SMART trials. Specifically, each of the outcome measures will be subjected to the following primary analyses: Main effect of Phase 1 randomization. Regressions with group membership as a predictor will be used to determine the effect of randomizing participants to either (a) the RTI problem-solving framework approach or (b) business as usual. Main effect of Phase 3 randomization. Regressions with group membership as a predictor will be used to determine the effect of randomizing non-responders to both Tier 1 classroom management strategies and Tier 2A basic RTI to either (a) enhanced RTI or (b) medication management. Pairwise comparisons of the three embedded treatment protocols. This SMART design has three embedded treatment protocols, or sets of decision rules that together define an adaptive intervention. Those three protocols are as follows: Business as usual (BAU) Tier 1 strategies, followed by Tier II strategies in the event of non-response (i.e., a DRC), followed by enhanced RTI in the event of non-response. Tier 1 strategies, followed by Tier II strategies in the event of non-response, followed by medication management in the event of non-response

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Business as Usual (BAU)
Arm Type
No Intervention
Arm Description
One-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.
Arm Title
Response to Intervention (RTI): Tier 1
Arm Type
Experimental
Arm Description
Two-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.
Arm Title
RTI: Daily Report Card (DRC)
Arm Type
Experimental
Arm Description
Students 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.
Arm Title
RTI: Enhanced
Arm Type
Experimental
Arm Description
Half 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.
Arm Title
Medication
Arm Type
Experimental
Arm Description
Half 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.
Intervention Type
Behavioral
Intervention Name(s)
Tier 1 Classroom Management
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Daily Report Card (DRC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced DRC (DRC-E)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Stimulant
Other Intervention Name(s)
long-acting methylphenidate, long-acting mixed amphetamine salts
Intervention Description
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.
Primary Outcome Measure Information:
Title
Observations of Classroom Behavior
Description
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).
Time Frame
End of academic year 1 of enrollment
Secondary Outcome Measure Information:
Title
Disruptive Behavior Disorders Rating Scale
Description
Teachers will complete ratings of student classroom behavior
Time Frame
End of academic year 1 of enrollment
Title
Impairment Rating Scale
Description
Teacher rating of student impairment
Time Frame
End of academic year 1 of enrollment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William E Pelham, PhD
Phone
305-348-2882
Email
wpelham@fiu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy R Altszuler, PhD
Phone
305-348-8496
Email
aaltszul@fiu.edu
Facility Information:
Facility Name
Florida International University Center for Children and Families
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William E Pelham, PhD
Phone
305-348-0477
Email
wpelham@fiu.edu
First Name & Middle Initial & Last Name & Degree
William E Pelham, Ph.D.
First Name & Middle Initial & Last Name & Degree
Nicole K Schatz, Ph.D.
Facility Name
Center for Children and Families, University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory A Fabiano, PhD
Phone
716-645-1130
Email
fabiano@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Gregory A Fabiano, Ph.D.

12. IPD Sharing Statement

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Adaptive Response to Intervention (RTI) for Students With ADHD

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