Can a simple toolkit make pediatric research more inclusive?
NCT ID NCT07166913
First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests whether a toolkit of strategies—like setting up advisory boards and making materials easier to understand—can improve how patients, families, and researchers work together in pediatric studies. Researchers will compare studies using the toolkit to those using standard practices. The goal is to see if better engagement helps studies recruit and retain participants and meet their goals.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toolkit (behavioral intervention)
- What this could lead to
- If successful, this could provide a proven way to involve patients and families more effectively in pediatric research, leading to more inclusive and successful studies.
- What could go wrong
- This is an early-stage study focused on process, not a treatment. The toolkit may not improve outcomes as hoped, and results may not apply to all research settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 480 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: In order to be eligible to participate in this study, PIs must oversee a study that meets the following criteria: 1. Studies who either have not started enrollment or are within 1-3 months of the start of enrollment, and within the 25% ceiling for % recruitment target. 2. Studies that have started enrollment must be no further than 25% of projected enrollment timeline of the study (with at least 6 months remaining for enrollment). 3. Target n\>50 participants in study. 4. At least 10 stakeholder partners part of study. The PI's must also be ≥18 years old; In order for study stakeholders to be eligible to participate in this study, an individual must meet all of the following criteria: 1. \>=12 years old; 2. Ability to speak either English, Spanish, or Chinese, and; 3. Part of the study team or serving in an advisory capacity to the study team The same criteria as that used for stakeholder and PI eligibility applies to Key informant (KI) interviews. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Not able to complete 6 month follow-up assessment 2. Children who are wards/foster children 3. Not able or willing to provide consent. 4. Concurrent enrollment in another study that is part of this research project. In addition, PI's who meet the following criteria will be excluded from participation in this study: 1\. A lot of experience with stakeholder engagement (based on screener survey question)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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