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

Children's Hospital of Philadelphia (CHOP)

Status: Invitation-only

Conditions: Attention Deficit Hyperactivity Disorder Symptoms

Treatments: Behavioral: Positive Behavioral Management Toolkit for Teachers; Behavioral: Positive Behavior Management Toolkit for Caregivers

Study type: Interventional

Funder types: Other

Identifiers

NCT07321327

25-023858

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention Group

Experimental group

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 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.

Treatment:

Behavioral: Positive Behavior Management Toolkit for Caregivers

Behavioral: Positive Behavioral Management Toolkit for Teachers

Control Group

Active Comparator group

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 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.

Treatment:

Behavioral: Positive Behavioral Management Toolkit for Teachers