Personalized Stories for Pediatric Kidney Recipients

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

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

Study Locations

    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75015
        • Recruiting
        • Necker hospital
        • Contact:

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

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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