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

NCT07321327 | Enrolling By Invitation

• 1 other identifier: 25-023858
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Attention Deficit Hyperactivity Disorder Symptoms

Keywords

Attention Deficit Hyperactivity Disorder Positive Behavior Management; Inattentive; Hyperactive; Impulsive

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (4)

• Change in Caregiver-reported ADHD symptoms

  Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)

• Change in Teacher-reported ADHD symptoms

  Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)

• Change in Student-Teacher Relationship

  Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)

• Change in academic success

  Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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; Behavioral: Positive Behavioral Management Toolkit for Teachers

Control Group

ACTIVE COMPARATOR

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

Interventions

Positive Behavior Management Toolkit for Caregivers BEHAVIORAL

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.

Also known as: Implementation Strategy Resource Package for Caregivers, Supporting School Success - Caregiver Version (SSS-C)

Intervention Group

Positive Behavioral Management Toolkit for Teachers BEHAVIORAL

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.

Also known as: Implementation Strategy Resource Package for Teachers, Supporting School Success - Teacher Version (SSS-T)

Control Group; Intervention Group

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Spasm; Impulsive Behavior

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participating teachers, and the students and students' caregivers nested within their classroom, are randomized to one of two conditions: implementation strategy resource package for teacher and caregiver, or implementation strategy resource package for teacher only.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)