Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions: Aim 2

The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors, when provided as an adjunct to a resource package for teachers. Participating children will be randomized at the classroom level to one of two conditions: a) their teacher and caregiver receive the resource package, or b) only their teacher receive the resource package. The research team will examine teacher and caregiver implementation outcomes and mental health outcomes for enrolled children.

Study Overview

• Status: Enrolling by invitation
• Conditions: Attention Deficit Hyperactivity Disorder Symptoms
• Intervention / Treatment: Behavioral: Positive Behavior Management Toolkit for Caregivers; Behavioral: Positive Behavioral Management Toolkit for Teachers

Detailed Description

Evidence-based interventions for children with or at-risk for Attention Deficit Hyperactivity Disorder (ADHD) include antecedent- and consequence- based behavioral interventions in both the classroom and home settings as well as effective home-school communication approaches. Schools are a promising setting in which to provide early intervention for mental health challenges and to increase access to mental health care. Furthermore, stronger integration between home- and school- based interventions has the potential to meaningfully improve child outcomes. However, there are substantial implementation challenges to caregivers' use of these evidence-based interventions. The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors, when provided as an adjunct to a resource package for teachers. Participating children will be randomized at the classroom level to one of two conditions: a) both teacher and caregiver receive the resource package, or b) only the teacher receive the resource package. The research team will examine teacher and caregiver implementation outcomes and mental health outcomes for enrolled children.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Teacher Inclusion criteria

• A K-5 teacher at a participating school
• Informed consent

Child Inclusion Criteria

• Is in a K-5 (ages 4-13 years) class of a participating teacher
• Nominated for participation by the participating teacher
• Identified by their participating teacher as displaying functional impairment from ADHD symptoms, as measured by a score of a 3 or greater on the modified version of the Impairment Rating Scale.
• Informed consent and assent if appropriate

Child Exclusion Criteria

• Special education classification of 'intellectual disability'
• Presents as in acute risk of harm to self or others, such that participation in the study is clinically inappropriate because the child warrants more intensive intervention
• Students from families in which there is not a caregiver who speaks English will be excluded because the focus of this study is developing an English-language version of the resource package

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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 up to 2 students nested in the classroom and their caregivers. Caregivers in this group will receive an implementation support package and receive support in using it.	Behavioral: Positive Behavior Management Toolkit for Caregivers; The Positive Behavior Management Toolkit for Caregivers, or the implementation strategy resource package for caregivers, is a set of resources provided that aims to support their use of evidence-based behavior management practices and home-school communication strategies.; Other Names: Implementation Strategy Resource Package for Caregivers; Supporting School Success - Caregiver Version (SSS-C); Behavioral: Positive Behavioral Management Toolkit for Teachers; The Positive Behavior Management Toolkit for Teachers, or the implementation strategy resource package for teachers, is a set of resources provided that aims to support their use of evidence-based behavior management practices and home-school communication strategies.; Other Names: Implementation Strategy Resource Package for Teachers; Supporting School Success - Teacher Version (SSS-T)
Active Comparator: Control Group; Teachers in this group will receive an implementation support package and receive support in using it within their classroom management practice. Also within the control group (active comparator) will be up to 2 students nested in the classroom and their caregivers. Caregivers in this group will not receive the implementation resource package.	Behavioral: Positive Behavioral Management Toolkit for Teachers; The Positive Behavior Management Toolkit for Teachers, or the implementation strategy resource package for teachers, is a set of resources provided that aims to support their use of evidence-based behavior management practices and home-school communication strategies.; Other Names: Implementation Strategy Resource Package for Teachers; Supporting School Success - Teacher Version (SSS-T)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intervention Measure - Caregiver Report	Caregiver-reported total score on the Feasibility of Intervention Measure (FIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).	Endpoint (i.e., at least 8 weeks from resource package receipt)
Feasibility of Intervention Measure - Teacher Report	Teacher-reported total score on the Feasibility of Intervention Measure (FIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).	Endpoint (i.e., at least 8 weeks from resource package receipt)
Acceptability of Intervention Measure - Caregiver Report	Caregiver-reported total score on the Acceptability of Intervention Measure (AIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).	Endpoint (i.e., at least 8 weeks from resource package receipt)
Acceptability of Intervention Measure - Teacher Report	Teacher-reported total score on the Acceptability of Intervention Measure (AIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).	Endpoint (i.e., at least 8 weeks from resource package receipt)
Intervention Appropriateness Measure - Caregiver Report	Caregiver-reported total score on the Intervention Appropriateness Measure (IAM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).	Endpoint (i.e., at least 8 weeks from resource package receipt)
Intervention Appropriateness Measure - Teacher Report	Teacher-reported total score on the Intervention Appropriateness Measure (IAM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).	Endpoint (i.e., at least 8 weeks from resource package receipt)
Change in teacher-report child performance	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 1 = Excellent to 5 = Problematic). The total score is the average of the 8 item scores (possible range 1 through 5, where 1 is the best possible outcome).	Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in caregiver-report child performance	Caregiver-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version; These 7 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 7 item scores (possible range 1 through 5, where 1 is the best possible outcome).	Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in teacher-reported parent-teacher relationship	Teacher-reported items on a 5-item subscale from the Parent-Teacher Involvement Questionnaire. These 5 items are rated on a 5-point scale (from 0 to 4). The total score is the average of the 5 item scores (possible range 0 to 4, where 4 is the best possible outcome).	Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in caregiver-reported parent-teacher relationship	Caregiver-reported items on a 6-item subscale from the Parent-Teacher Involvement Questionnaire. These 6 items are rated on a 5-point scale (from 0 = "not at all" to 4 = "a great dael"). The total score is the average of the 6 item scores (possible range 0 to 4, where 4 is the best possible outcome).	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 5-point Likert scale from 1 to 5. Four items are reverse scored, and the total score is computed as the average of the 12 items (possible range: 1 through 5, where 5 is the best possible outcome).	Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Caregiver-reported ADHD symptoms	Caregiver-reported inattention and hyperactivity/impulsivity symptoms scores on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version, which consists of 18 items, rated on 4-point scales (from 0 = Never to 3 = Very Often). The total score is calculated as the average of the of the 18 item scores (possible range 0 through 3, where 0 is the best possible outcome).	Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in Teacher-reported ADHD symptoms	Teacher-reported inattention and hyperactivity/impulsivity symptoms scores on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version, which consists of 18 items, rated on 4-point scales (from 0 = Never to 3 = Very Often). The total score is calculated as the average of the of the 18 item scores (possible range 0 through 3, where 0 is the best possible outcome).	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). Eight items are reverse scored and then the total score is computed as the average of the 15 item scores (possible range: 1 through 5, where 5 is the best possible outcome).	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 7 items, each rated on a 5-point Likert scale from 1 to 5. One item is reverse scored, and the total score is computed as the average of the 7 items (possible range: 1 through 5, where 5 is the best possible outcome).	Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Inattentive; Hyperactive; Impulsive; Attention Deficit Hyperactivity Disorder Positive Behavior Management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Spasm; Impulsive Behavior; Health Care Facilities Workforce and Services; Health Personnel; Caregivers
• Other Study ID Numbers: 25-023858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No