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Completed

NCT Number: NCT06770036

Caregiver Implementation Strategies Field Pre-Test

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Symptoms Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Impulsive Behavior Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implementation Resource Package for Caregivers

Behavioral

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.

Other names: Supporting School Success - Caregiver Version, Positive Behavior Management Toolkit for Caregivers

Primary outcomes

  1. Feasibility of Intervention Measure

    Time frame: Endpoint (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.

  2. Acceptability of Intervention Measure

    Time frame: Endpoint (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.

  3. Intervention Appropriateness Measure

    Time frame: Endpoint (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.

  4. Change in observed caregiver fidelity to behavioral interventions

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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