ClinicalTrials.gg
CompletedNCT06770036Updated Jan 26, 2026

Caregiver Implementation Strategies Field Pre-Test

An interventional study of Implementation Resource Package for Caregivers in Attention Deficit Hyperactivity Disorder Symptoms, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
4 Years and older
Sex
All
01

Study summary

The purpose of this study is to field pre-test an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors. Enrolled caregivers will be assigned to use the resource package with their children. The research team will collect quantitative and qualitative data regarding acceptability, appropriateness, and feasibility, in preparation for a randomized pilot study.

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. This study aims to field pre-test an implementation strategy resource package to support caregivers in using evidence-based behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors. After an initial iterative process of developing the resource package, enrolled caregivers will use the resource package with their children in a single-arm study, for the purpose of assessing initial implementation outcomes and making final adjustments to the resource package.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder Symptoms

Keywords

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

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's enrollment of 20 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity 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
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Students in or entering grades K-5 in the greater Philadelphia area
  • Nominated for participation by a school staff member or parent/legal guardian
  • Identified by that staff member or parent/legal guardian 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Special education classification of 'intellectual disability'
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Caregiver Resource Package

    Caregiver in this group will receive an implementation resource support package and will receive support in using it.

    Behavioral: Implementation Resource Package for Caregivers

Interventions

  • BehavioralImplementation Resource Package for Caregivers

    The implementation resource package for caregivers is a set of resources provided to caregivers that aims to support their use of evidence-based behavior management practices and home-school communication strategies.

    Also known as: Supporting School Success - Caregiver Version, Positive Behavior Management Toolkit for Caregivers

06

What researchers measure

Primary outcomes

  1. Feasibility of Intervention Measure

    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.

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

  2. Acceptability of Intervention Measure

    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.

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

  3. Intervention Appropriateness Measure

    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.

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

  4. Change in observed caregiver fidelity to behavioral interventions

    A member of the study will conduct observations to measure fidelity of caregiver use of the behavioral interventions.

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

07

Study locations

1 site
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19146, United States
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 Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06770036
Responsible party
Sponsor
First posted
Jan 13, 2025
Start date
Jul 30, 2025
Primary completion
Jan 21, 2026
Completion
Jan 23, 2026
Last update
Jan 26, 2026

Study contacts

Gwendolyn M Lawson, PhD
principal investigator · Children's Hospital of Philadelphia

Oversight

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

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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