Clinical trial NCT03511976: Adaptive Response to Intervention (RTI) for Students With ADHD
Official title: Adaptive Response to Intervention (RTI) for Students With ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: University at Buffalo
First posted: 2018-04-30
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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:

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

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

Primary outcomes:
measure: Observations of Classroom Behavior
timeFrame: End of academic year 1 of enrollment
Secondary outcomes:
measure: Disruptive Behavior Disorders Rating Scale
timeFrame: End of academic year 1 of enrollment
measure: Impairment Rating Scale
timeFrame: End of academic year 1 of enrollment
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University Center for Children and Families
state: Florida
city: Buffalo
country: United States
facility: Center for Children and Families, University at Buffalo
state: New York
Study officials:
References: