Adaptive Response to Intervention (RTI) for Students With ADHD
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/13/2018 |
| Start Date: | May 14, 2018 |
| End Date: | June 2021 |
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.
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.
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:
1. Business as usual (BAU)
2. 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.
3. Tier 1 strategies, followed by Tier II strategies in the event of non-response, followed
by medication management in the event of non-response
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:
1. Business as usual (BAU)
2. 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.
3. Tier 1 strategies, followed by Tier II strategies in the event of non-response, followed
by medication management in the event of non-response
Inclusion Criteria:
- Child meets DSM-V diagnostic criteria for Attention-Deficit/Hyperactivity Disorder
- Child will be entering grades 1 - 5
Exclusion Criteria:
- Child 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
We found this trial at
2
sites
Miami, Florida 33199
Principal Investigator: William E Pelham, Ph.D.
Phone: 305-348-0477
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Buffalo, New York 14214
Principal Investigator: Gregory A Fabiano, Ph.D.
Phone: 716-645-1130
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