ClinicalTrials.gg
Enrolling by invitationNCT07321327Updated Feb 5, 2026

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

An interventional study of Positive Behavior Management Toolkit for Caregivers and Positive Behavioral Management Toolkit for Teachers in Attention Deficit Hyperactivity Disorder Symptoms, sponsored by Children's Hospital of Philadelphia. Enrolling by invitation at 1 site in United States. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
4 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder Symptoms

Keywords

  • Attention Deficit Hyperactivity Disorder Positive Behavior Management
  • Inattentive
  • Hyperactive
  • Impulsive
03

In context

Spasm

123 studies on the registry are indexed under Spasm; 7 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 104 interventional studies indexed under Spasm.

Browse Spasm studies →

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Teacher Inclusion criteria

  • A K-5 teacher at a participating school

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Positive Behavior Management Toolkit for Caregivers · Behavioral: Positive Behavioral Management Toolkit for Teachers

  • Active comparator
    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.

    Behavioral: Positive Behavioral Management Toolkit for Teachers

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.

    Also known as: Implementation Strategy Resource Package for Caregivers, Supporting School Success - Caregiver Version (SSS-C)

  • 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.

    Also known as: Implementation Strategy Resource Package for Teachers, Supporting School Success - Teacher Version (SSS-T)

06

What researchers measure

Primary outcomes

  1. Feasibility of Intervention Measure - Caregiver Report

    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).

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

  2. Feasibility of Intervention Measure - Teacher Report

    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).

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

  3. Acceptability of Intervention Measure - Caregiver Report

    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).

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

  4. Acceptability of Intervention Measure - Teacher Report

    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).

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

  5. Intervention Appropriateness Measure - Caregiver Report

    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).

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

  6. Intervention Appropriateness Measure - Teacher Report

    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).

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

  7. Change in teacher-report child performance

    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).

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

  8. Change in caregiver-report child performance

    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).

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

  9. Change in teacher-reported parent-teacher relationship

    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).

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

  10. Change in caregiver-reported parent-teacher relationship

    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).

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

  11. Change in academic productivity

    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).

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

Secondary outcomes

  1. Change in Caregiver-reported ADHD symptoms

    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).

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

  2. Change in Teacher-reported ADHD symptoms

    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).

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

  3. Change in Student-Teacher Relationship

    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).

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

  4. Change in academic success

    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).

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07321327
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Feb 3, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Feb 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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