Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test

Study Overview
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Brief Summary
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The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Participating teachers will be randomized to receive the resource package or support as usual and the research team will examine, a) teacher implementation of behavioral classroom interventions and b) mental health outcomes for enrolled children.

Detailed Description
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Schools are an accessible and ecologically valid setting for children with hyperactivity, inattentive, or impulsive behaviors to receive evidence-based interventions to reduce symptoms and improve functioning. Behavioral classroom management interventions are well-established treatments for elementary-school age children with, but they can often be challenging for teachers to use. It is therefore important to develop and test implementation strategies in promoting teachers' use of behavioral classroom management interventions and in improving child outcomes. The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Participating teachers will be randomized to receive the resource package or support as usual and the research team will examine, a) teacher implementation of behavioral classroom interventions and b) mental health outcomes for enrolled children.

Official Title
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Promoting Implementation of Behavioral Classroom Interventions for Children With ADHD in Urban Schools: A Pilot Test, Aim 3

Conditions
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Attention Deficit Hyperactivity Disorder Symptoms

Intervention / Treatment
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* Behavioral: Positive Behavior Management Toolkit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Teachers: A K-5 teacher at a participating school within the School District of Philadelphia Teach at a participating school Informed consent Children: Is in a K-5 class of a participating teacher Nominated for participation by the participating teacher Identified by their participating teacher as displaying impairment related to inattention, hyperactivity or impulsivity Informed consent and assent if appropriate Parents/Legal Guardians: Parent or legal guardian of child Identifies as familiar enough with the child to fill out measures about the child Has mental capacity to provide consent for the participation of child in the study and for their own participation in the study Caregivers: Has been referred by the legal guardian as the primary caregiver that can more accurately complete the measures about the child Has mental capacity to provide consent for the participation of child in the study and for their own participation in the study Exclusion Criteria: Children: Special education classification of 'intellectual disability' Primary presenting concern of psychotic or autism spectrum disorders Presents as in acute risk of harm to self or others, such that participation in the study is clinically inappropriate because they warrant more intensive intervention

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participating teachers, and the students nested within their classroom, are randomized to one of two conditions: implementation strategy resource package or support as usual.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation Resource Package Group<br>Teachers in this group will receive an implementation support package and receive support in using it within their classroom management practice. Also within the intervention group (experimental), will be students nested in the classrooms of the teachers that are assigned to the intervention group. | Behavioral: Positive Behavior Management Toolkit<br>* The Positive Behavior Management Toolkit, or the implementation strategy resource package, is a set of resources provided to teachers in the intervention group that aims to support their use of positive behavior management practices in the classroom, particularly with students with hyperactive, inattentive, or impulsive behaviors.<br>* Other names: Support School Success - Teacher Version (SSS-T);|
| No Intervention: Control Group<br>Within the control group (no intervention), teachers in this group will not receive the implementation support package nor extra support during the study period. They will continue to receive implementation support as usual. Also within the control group (no intervention) will be students nested in the classrooms of the teachers that are assigned to the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Intervention Measure | Teacher-reported total score on the Feasibility of Intervention Measure (FIM), which consists of 4 items on a 5-point Likert scale (from Completely Disagree to Completely Agree). The total score is the average of the 4 item scores. | Endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Acceptability of Intervention Measure (AIM) | Teacher-reported total score on the Acceptability of Intervention Measure (AIM), which consists of 4 items on a 5-point Likert scale (from Completely Disagree to Completely Agree). The total score is the average of the 4 item scores. | Endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Intervention Appropriateness Measure (IAM) | Teacher-reported total score on the Intervention Appropriateness Measure (IAM), which consists of 4 items on a 5-point Likert scale (from Completely Disagree to Completely Agree). The total score is the average of the 4 item scores. | Endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Change in observed teacher use of behavioral classroom management interventions | A member of the study will conduct classroom observations to measure fidelity of teacher use of the behavioral classroom management interventions. | Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Change in caregiver-reported Child Functional Impairment | Caregiver-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version; These 8-items are rated on a 5-point scale (from Excellent to Problematic). | Baseline, endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Change in teacher-reported Child Functional Impairment | Teacher-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version; These 8-items are rated on a 5-point scale (from Excellent to Problematic). | Baseline, endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Change in Academic Productivity | Teacher-reported Academic Productivity subscale score of the Academic Performance Rating Scale (APRS). The Academic Productivity subscale includes 12 items, each rated on a scale from 1 to 5. | Baseline, endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Change in Student-Teacher Relationship | Teacher-reported total score on the Student-Teacher Relationship Scale - Short form, which consists of 15 items, rated on a 5-point scale (from 1 = Definitely does not apply to 5 = Definitely applies). | Baseline, endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Feasibility of research procedures - Recruitment numbers | Number of teachers and students enrolled in the study | Baseline | 
| Feasibility of research procedures - Response rate | Proportion of parent- and teacher- report surveys completed across timepoints and conditions out of the number of teachers and students enrolled and randomized | Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Feasibility of research procedures - Retention rate | Proportion of participants who do not withdraw out of the number of enrolled and randomized teachers and students across conditions | Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Homework Performance | Caregiver-reported student self-regulation factor on the Homework Performance Questionnaire - Parent Version for students in grades 1-5. The self-regulation factor consists of 9 items, each rated on a 4-point scale (0 = rarely/never, 1 = some of the time, 2 = most of the time, 3 = always/almost always). | Baseline, endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Change in caregiver-reported ADHD Symptoms | Caregiver-reported inattention and hyperactivity/impulsivity symptom scores on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version, which consists of 18 items, rated on a 4-point scale (from 0 = Never to 3 = Very Often). | Baseline, endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Change in teacher-reported ADHD Symptoms | Teacher-reported inattention and hyperactivity/impulsivity symptom scores on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version, which consists of 18 items, rated on a 4-point scale (from 0 = Never to 3 = Very Often). | Baseline, endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Change in Academic Success | Teacher-reported Academic Success subscale score of the Academic Performance rating Scale (APRS). The Academic Success subscale includes 6 items, each rated on a scale from 1 to 5. | Baseline, endpoint (i.e, at least 8 weeks from resource package receipt) | 
| Change in engagement and Disruptive Direct Behavior Ratings | Teacher-reported ratings on the engagement and disruptive behavior domains of Direct Behavior Rating Multi-Item Scales, each of which consist of 5 items on a 6-point scale. | Baseline, endpoint (i.e, at least 8 weeks from resource package receipt) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Hyperactivity Disorder, Positive Behavior Management, Positive Behavioral Interventions and Supports, Behavioral Classroom Management, Inattentive, Hyperactive, Impulsive