Caregiver Implementation Strategies Field Pre-Test

Not Applicable

Not yet recruiting

• Conditions: Attention Deficit Hyperactivity Disorder Symptoms

• Registration Number: NCT06770036
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-09
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Grades K-5
• Nominated for participation by a school staff member
• Identified by that staff member 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Intervention Measure	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.
Acceptability of Intervention Measure	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.
Intervention Appropriateness Measure	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.
Change in observed caregiver fidelity to behavioral interventions	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.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States