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Recruiting NCT07532382

Personalized Stories for Pediatric Kidney Recipients

Observational Kidney Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-generated story, AI generated story.
Who it may be relevant to
Registry conditions: Kidney Transplant. Basic parameters: 5 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Generating Personalized Stories With Artificial Intelligence for Pediatric Kidney Recipients

Overview

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.

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.

Interventions

  • Other AI-generated story
    A story generated by artificial intelligence is created and personalized for pediatric kidney recipient
  • Other AI generated story
    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.

Primary outcome measures

  • Child and family experience of the story after delivery. [Time frame: One month after story delivery]
  • Child and family experience of the story after delivery. [Time frame: One month after the story is delivered]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Necker hospital — Paris

Publications

  • Lorenzini G, Arbelaez Ossa L, Milford S, Elger BS, Shaw DM, De Clercq E. The "Magical Theory" of AI in Medicine: Thematic Narrative Analysis. JMIR AI. 2024 Aug 19;3:e49795. doi: 10.2196/49795. PMID 39158953

Identifiers

NCT: NCT07532382 · LLM_Kids

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗