NCT05469815

Brief Summary

The Lost Children Society (LCS) is a Therapeutic TableTop Role-Playing Game specifically developed for early-onset schizophrenia patient. It is performed online via a secure teleconsultation and videoconference platform. Patients are connected from their home, on their personal computer or tablet, equipped with headsets with microphone. This study aims to validate the feasibility of this online Therapeutic TableTop Role Playing Game.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2023

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

June 23, 2022

Last Update Submit

July 17, 2025

Conditions

Keywords

Metacognitive TrainingEarly-onset SchizophreniaTherapeutic TableTop Role Playing GamePsychoeducational programLost Children Society

Outcome Measures

Primary Outcomes (1)

  • Overall feasibility of the Game

    Effective participation of the patient - feasibility will be defined by the number of effective sessions \> or = 29

    10 month

Study Arms (1)

Lost Children Society Game

EXPERIMENTAL

Online therapeutic role-playing session

Behavioral: Lost Children Society Game

Interventions

36 online therapeutic role-playing sessions spread over 36 weeks, one session per week

Lost Children Society Game

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of early onset schizophrenia
  • Patient who has the capacity to understand the protocol and to perform evaluations
  • Written informed consent to participate in the study given by the patient or by the parental authority of the minor patient.
  • Patient with social security coverage

You may not qualify if:

  • Intelligence quotient\<70 on Wechsler Adults Intelligence Scale-IV (for 17+ years) or the Wechsler Intelligence Scale for Children V (for 15-16 years).
  • Personal history of head trauma, neurological disorder, genetic disease.
  • Co-morbidities: major depressive episode or post-traumatic stress disorder unresolved or resolved within the last 6 months.
  • Lack of mastery or access to a computer or personal tablet in autonomy
  • Therapeutic history of metacognitive training.
  • Patient under guardianship, curators or legal protection
  • Patient going through a period of exacerbation of positive or negative psychotic signs likely to lead to a full-time hospitalization in a specialized environment within the next 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Jonathan PIONNIER

    EPSM de Vendée Georges Mazurelle

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

July 22, 2022

Study Start

April 13, 2023

Primary Completion

November 20, 2024

Study Completion

November 20, 2024

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share