CompletedNot Applicable

Caregiver Implementation Strategies Field Pre-Test

United States20 participantsStarted 2025-07-30

Plain-language 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.

Who can participate

Age range4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Feasibility of Intervention Measure

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

Acceptability of Intervention Measure

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

Intervention Appropriateness Measure

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

Change in observed caregiver fidelity to behavioral interventions

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

Trial details

NCT IDNCT06770036

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-21

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder Symptoms trials

Plain-language summary

Who can participate

Age range4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility of Intervention Measure

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

Acceptability of Intervention Measure

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

Intervention Appropriateness Measure

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

Change in observed caregiver fidelity to behavioral interventions

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