Skip to content

Caregiver Implementation Strategies Field Pre-Test

Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions With ADHD: A Pilot Study, Aim 1

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06770036
Enrollment
20
Registered
2025-01-13
Start date
2025-07-30
Completion date
2026-01-23
Last updated
2026-01-26

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 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.

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.

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.

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Intervention MeasureEndpoint (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.
Acceptability of Intervention MeasureEndpoint (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.
Intervention Appropriateness MeasureEndpoint (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.
Change in observed caregiver fidelity to behavioral interventionsBaseline, Endpoint (i.e, at least 8 weeks from resource package receipt)A member of the study will conduct observations to measure fidelity of caregiver use of the behavioral interventions.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGwendolyn M Lawson, PhD

Children's Hospital of Philadelphia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026