- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07532382
Personalized Stories for Pediatric Kidney Recipients
April 8, 2026 updated by: Marc Raynaud, Paris Translational Research Center for Organ Transplantation
Generating Personalized Stories With Artificial Intelligence for Pediatric Kidney Recipients
Pediatric kidney transplant recipients often face major psychosocial challenges that are difficult to address with existing tools.
This study evaluates whether clinically supervised AI can generate personalized, age-adapted therapeutic stories for these children and their families.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Pediatric kidney transplant recipients face substantial psychosocial challenges, including anxiety, fear, difficulty understanding complex medical experiences, and challenges returning to school and social life.
Therapeutic storytelling may help children process these experiences, but truly personalized stories are difficult to produce manually at scale.
Large language models offer the opportunity to generate age-adapted, personalized, and clinically supervised stories.
This study aims to develop and evaluate an AI-assisted storytelling workflow for pediatric kidney recipients and their families.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marc Raynaud, PhD
- Phone Number: +33613493009
- Email: mrayna06@gmail.com
Study Locations
-
-
Île-de-France Region
-
Paris, Île-de-France Region, France, 75015
- Recruiting
- Necker hospital
-
Contact:
- Evgenia Preka, MD, PhD
- Phone Number: +33144494000
- Email: evgenia.preka@aphp.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Pediatric kidney recipients
Description
Inclusion Criteria:
- Age 5-12 years inclusive at enrolment.
- Recipient of a kidney transplant.
- Clinically stable at enrolment (no active rejection, acute infection, or current hospitalization for a graft-related complication).
- Fluency in French or English.
- Written informed consent from parent(s)/legal guardian(s); child assent when age-appropriate.
Exclusion Criteria:
- Severe cognitive impairment precluding engagement with narrative content.
- Mental state not allowing participation.
- Family unwilling or unable to commit to the study timeline and interview requirements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pediatric kidney recipient
|
A story generated by artificial intelligence is created and personalized for pediatric kidney recipient
This is a minimal-risk observational study.
Families complete a questionnaire and receive an AI-generated, clinically supervised personalized story.
During the pilot phase, there is no direct child-AI interaction.
All stories are reviewed by the clinical lead before delivery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child and family experience of the story after delivery.
Time Frame: One month after story delivery
|
Child and family experience of the story, assessed through qualitative feedback, thematic analysis, and satisfaction ratings collected after story delivery.
|
One month after story delivery
|
|
Child and family experience of the story after delivery.
Time Frame: One month after the story is delivered
|
Child and family experience of the story, assessed through qualitative feedback, thematic analysis, and satisfaction ratings collected after story delivery.
|
One month after the story is delivered
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marc Raynaud, PhD, Paris Institute for Transplantation and Organ Regeneration
- Principal Investigator: Evgenia Preka, MD, PhD, Paris Institute for Transplantation and Organ Regeneration
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
April 8, 2026
First Submitted That Met QC Criteria
April 8, 2026
First Posted (Actual)
April 15, 2026
Study Record Updates
Last Update Posted (Actual)
April 15, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LLM_Kids
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
These will be data related to pediatric kidney recipients.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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