Personalized Stories for Pediatric Kidney Recipients

NCT07532382 | Recruiting

• 1 other identifier: LLM_Kids
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant

Keywords

Artificial intelligence

Outcome Measures

Primary Outcomes (2)

• Child and family experience of the story after 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.

  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

Study Arms (1)

Pediatric kidney recipient

Other: AI-generated story; Other: AI generated story

Interventions

AI-generated story OTHER

A story generated by artificial intelligence is created and personalized for pediatric kidney recipient

Pediatric kidney recipient

AI generated story OTHER

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.

Pediatric kidney recipient

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric kidney recipients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Study Sites (1)

Necker hospital

Paris, Île-de-France Region, 75015, France

RECRUITING

Related Publications (1)

• 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 RESULT

Study Officials

• Marc Raynaud, PhD

  Paris Institute for Transplantation and Organ Regeneration

  PRINCIPAL INVESTIGATOR

• Evgenia Preka, MD, PhD

  Paris Institute for Transplantation and Organ Regeneration

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Raynaud, PhD

CONTACT

+33613493009; mrayna06@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific leader

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)