Menu
Enrolling by invitation NCT07321327

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

No phase Interventional Attention Deficit Hyperactivity Disorder Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Positive Behavior Management Toolkit for Caregivers, Positive Behavioral Management Toolkit for Teachers.
Who it may be relevant to
Registry conditions: Attention Deficit Hyperactivity Disorder Symptoms. Basic parameters: from 4 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Feasibility of Intervention Measure - Caregiver Report [Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Feasibility of Intervention Measure - Teacher Report [Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Acceptability of Intervention Measure - Caregiver Report [Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Acceptability of Intervention Measure - Teacher Report [Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Intervention Appropriateness Measure - Caregiver Report [Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Intervention Appropriateness Measure - Teacher Report [Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in teacher-report child performance [Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in caregiver-report child performance [Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in teacher-reported parent-teacher relationship [Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in caregiver-reported parent-teacher relationship [Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
Secondary outcome measures (4)
  • Change in Caregiver-reported ADHD symptoms [Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in Teacher-reported ADHD symptoms [Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in Student-Teacher Relationship [Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in academic success [Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Children's Hospital of Philadelphia — Philadelphia

Identifiers

NCT: NCT07321327 · 25-023858

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗