Back to resultsImplementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test
Primary Purpose
Attention Deficit Hyperactivity Disorder Symptoms
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Behavior Management Toolkit
Sponsored by
About this trial
This is an interventional health services research trial for Attention Deficit Hyperactivity Disorder Symptoms focused on measuring Attention Deficit Hyperactivity Disorder, Positive Behavior Management, Positive Behavioral Interventions and Supports, Behavioral Classroom Management, Inattentive, Hyperactive, Impulsive
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Implementation Resource Package Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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).
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).
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.
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).
Feasibility of research procedures - Recruitment numbers
Number of teachers and students enrolled in the study
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
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
Secondary Outcome Measures
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).
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).
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).
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.
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.
Full Information
NCT ID
NCT05489081
First Posted
August 2, 2022
Last Updated
April 19, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05489081
Brief Title
Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test
Official Title
Promoting Implementation of Behavioral Classroom Interventions for Children With ADHD in Urban Schools: A Pilot Test, Aim 3
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder Symptoms
Keywords
Attention Deficit Hyperactivity Disorder, Positive Behavior Management, Positive Behavioral Interventions and Supports, Behavioral Classroom Management, Inattentive, Hyperactive, Impulsive
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implementation Resource Package Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive Behavior Management Toolkit
Other Intervention Name(s)
Implementation Strategy Resource Package, Support School Success - Teacher Version (SSS-T)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Intervention Measure
Description
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.
Time Frame
Endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Acceptability of Intervention Measure (AIM)
Description
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.
Time Frame
Endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Intervention Appropriateness Measure (IAM)
Description
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.
Time Frame
Endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Change in observed teacher use of behavioral classroom management interventions
Description
A member of the study will conduct classroom observations to measure fidelity of teacher use of the behavioral classroom management interventions.
Time Frame
Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Change in caregiver-reported Child Functional Impairment
Description
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).
Time Frame
Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Change in teacher-reported Child Functional Impairment
Description
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).
Time Frame
Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Change in Academic Productivity
Description
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.
Time Frame
Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Change in Student-Teacher Relationship
Description
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).
Time Frame
Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Feasibility of research procedures - Recruitment numbers
Description
Number of teachers and students enrolled in the study
Time Frame
Baseline
Title
Feasibility of research procedures - Response rate
Description
Proportion of parent- and teacher- report surveys completed across timepoints and conditions out of the number of teachers and students enrolled and randomized
Time Frame
Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Feasibility of research procedures - Retention rate
Description
Proportion of participants who do not withdraw out of the number of enrolled and randomized teachers and students across conditions
Time Frame
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 Measure Information:
Title
Change in Homework Performance
Description
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).
Time Frame
Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Change in caregiver-reported ADHD Symptoms
Description
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).
Time Frame
Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Change in teacher-reported ADHD Symptoms
Description
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).
Time Frame
Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Change in Academic Success
Description
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.
Time Frame
Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Title
Change in engagement and Disruptive Direct Behavior Ratings
Description
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.
Time Frame
Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Other Pre-specified Outcome Measures:
Title
Potential mediators of teacher implementation outcomes
Description
Teacher self-reported measures of potential mediators of teacher implementation outcomes: intentions to use behavioral classroom management interventions, psychological determinants of intentions, and habits regarding behavioral classroom management interventions
Time Frame
Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwendolyn M Lawson, PhD
Organizational Affiliation
Children's Hospital of Philadelphia/University of Pennsylvania Perelman School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test
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