Caregiver Implementation Strategies Field Pre-Test (NCT06770036) | Clinical Trial Compass
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 range
4 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Intervention Measure
Timeframe: Endpoint (i.e, at least 8 weeks from resource package receipt)
2
Acceptability of Intervention Measure
Timeframe: Endpoint (i.e, at least 8 weeks from resource package receipt)
3
Intervention Appropriateness Measure
Timeframe: Endpoint (i.e, at least 8 weeks from resource package receipt)
4
Change in observed caregiver fidelity to behavioral interventions
Timeframe: Baseline, Endpoint (i.e, at least 8 weeks from resource package receipt)