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Clinical Trials/NCT07321327
NCT07321327
Enrolling By Invitation
Not Applicable

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

Children's Hospital of Philadelphia1 site in 1 country100 target enrollmentStarted: February 3, 2026Last updated:

Overview

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
100
Locations
1
Primary Endpoint
Feasibility of Intervention Measure - Caregiver Report

Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
4 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

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

Arms & Interventions

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.

Intervention: Positive Behavior Management Toolkit for Caregivers (Behavioral)

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.

Intervention: Positive Behavioral Management Toolkit for Teachers (Behavioral)

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.

Intervention: Positive Behavioral Management Toolkit for Teachers (Behavioral)

Outcomes

Primary Outcomes

Feasibility of Intervention Measure - Caregiver Report

Time Frame: Endpoint (i.e., at least 8 weeks from resource package receipt)

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).

Feasibility of Intervention Measure - Teacher Report

Time Frame: Endpoint (i.e., at least 8 weeks from resource package receipt)

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).

Acceptability of Intervention Measure - Caregiver Report

Time Frame: Endpoint (i.e., at least 8 weeks from resource package receipt)

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).

Change in caregiver-report child performance

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

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).

Acceptability of Intervention Measure - Teacher Report

Time Frame: Endpoint (i.e., at least 8 weeks from resource package receipt)

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).

Intervention Appropriateness Measure - Teacher Report

Time Frame: Endpoint (i.e., at least 8 weeks from resource package receipt)

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).

Intervention Appropriateness Measure - Caregiver Report

Time Frame: Endpoint (i.e., at least 8 weeks from resource package receipt)

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).

Change in teacher-report child performance

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

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).

Change in teacher-reported parent-teacher relationship

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

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).

Change in caregiver-reported parent-teacher relationship

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

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).

Change in academic productivity

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

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).

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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