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

NCT ID: NCT07321327

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2027-06-30

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.

Conditions

Attention Deficit Hyperactivity Disorder Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Positive Behavior Management Toolkit for Caregivers

Intervention Type: 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.

Positive Behavioral Management Toolkit for Teachers

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Positive Behavioral Management Toolkit for Teachers

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Implementation Strategy Resource Package for Caregivers; Supporting School Success - Caregiver Version (SSS-C); Implementation Strategy Resource Package for Teachers; Supporting School Success - Teacher Version (SSS-T)

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Central Contacts

Gwendolyn Lawson, PhD

Role: CONTACT

lawsong@chop.edu

(267) 426-6612

Molly Kerstetter, MPH

Role: CONTACT

kerstettem@chop.edu

Facility Contacts

Gwendolyn Lawson, PhD

Role: primary

Other Identifiers

25-023858

Identifier Type: -

Identifier Source: org_study_id