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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07321327
Enrollment
100
Registered
2026-01-07
Start date
2026-02-03
Completion date
2027-06-30
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder Symptoms

Keywords

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

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.

Interventions

BEHAVIORALPositive 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.

BEHAVIORALPositive 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.

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
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 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Intervention Measure - Caregiver ReportEndpoint (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 ReportEndpoint (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 ReportEndpoint (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).
Acceptability of Intervention Measure - Teacher ReportEndpoint (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 - Caregiver ReportEndpoint (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).
Intervention Appropriateness Measure - Teacher ReportEndpoint (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).
Change in teacher-report child performanceBaseline, 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 caregiver-report child performanceBaseline, 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).
Change in teacher-reported parent-teacher relationshipBaseline, 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 relationshipBaseline, 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 productivityBaseline, 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

MeasureTime frameDescription
Change in Caregiver-reported ADHD symptomsBaseline, endpoint (i.e., at least 8 weeks from resource package receipt)Caregiver-reported inattention and hyperactivity/impulsivity symptoms scores on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version, which consists of 18 items, rated on 4-point scales (from 0 = Never to 3 = Very Often). The total score is calculated as the average of the of the 18 item scores (possible range 0 through 3, where 0 is the best possible outcome).
Change in Teacher-reported ADHD symptomsBaseline, endpoint (i.e., at least 8 weeks from resource package receipt)Teacher-reported inattention and hyperactivity/impulsivity symptoms scores on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version, which consists of 18 items, rated on 4-point scales (from 0 = Never to 3 = Very Often). The total score is calculated as the average of the of the 18 item scores (possible range 0 through 3, where 0 is the best possible outcome).
Change in Student-Teacher RelationshipBaseline, endpoint (i.e., at least 8 weeks from resource package receipt)Teacher-reported total score on the Student-Teacher Relationship Scale - Short form, which consists of 15 items, rated on a 5-point scale (from 1 = Definitely does not apply to 5 = Definitely applies). Eight items are reverse scored and then the total score is computed as the average of the 15 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Change in academic successBaseline, endpoint (i.e., at least 8 weeks from resource package receipt)Teacher-reported Academic Success subscale score of the Academic Performance rating Scale (APRS). The Academic Success subscale includes 7 items, each rated on a 5-point Likert scale from 1 to 5. One item is reverse scored, and the total score is computed as the average of the 7 items (possible range: 1 through 5, where 5 is the best possible outcome).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026