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Caregiver Implementation Strategies Field Pre-Test

Children's Hospital of Philadelphia (CHOP) logo

Children's Hospital of Philadelphia (CHOP)

Status

Completed

Conditions

Attention Deficit Hyperactivity Disorder Symptoms

Treatments

Behavioral: Implementation Resource Package for Caregivers

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06770036
R34MH132718-01A1 (U.S. NIH Grant/Contract)
24-021965

Details and patient eligibility

About

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.

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. 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.

Enrollment

20 patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

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

  • 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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Caregiver Resource Package
Experimental group
Description:
Caregiver in this group will receive an implementation resource support package and will receive support in using it.
Treatment:
Behavioral: Implementation Resource Package for Caregivers

Trial contacts and locations

1

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Central trial contact

Gwendolyn Lawson, PhD

Data sourced from clinicaltrials.gov

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