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Lost Children Society (LCS), Online Therapeutic Tabletop Role-playing Game for Early-onset Schizophrenia Patients (TTRPG)

Primary Purpose

Schizophrenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lost Children Society Game
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring Metacognitive Training, Early-onset Schizophrenia, Therapeutic TableTop Role Playing Game, Psychoeducational program, Lost Children Society

Eligibility Criteria

15 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hopital Louis Mourier
  • Centre Hospitalier Georges Mazurelle
  • Centre Hospitalier Universitaire

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lost Children Society Game

Arm Description

Online therapeutic role-playing session

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 23, 2022
Last Updated
July 26, 2023
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT05469815
Brief Title
Lost Children Society (LCS), Online Therapeutic Tabletop Role-playing Game for Early-onset Schizophrenia Patients
Acronym
TTRPG
Official Title
Lost Children Society (LCS), Metacognitive Training Integrated Into an Online Therapeutic Tabletop Role-playing Game for Early-onset Schizophrenia Patients : a Pilot Study on Feasibility
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Metacognitive Training, Early-onset Schizophrenia, Therapeutic TableTop Role Playing Game, Psychoeducational program, Lost Children Society

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lost Children Society Game
Arm Type
Experimental
Arm Description
Online therapeutic role-playing session
Intervention Type
Behavioral
Intervention Name(s)
Lost Children Society Game
Intervention Description
36 online therapeutic role-playing sessions spread over 36 weeks, one session per week
Primary Outcome Measure Information:
Title
Overall feasibility of the Game
Description
Effective participation of the patient - feasibility will be defined by the number of effective sessions > or = 29
Time Frame
10 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès DORION
Phone
251446380
Ext
+33
Email
agnes.dorion@ght85.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan PIONNIER
Organizational Affiliation
EPSM de Vendée Georges Mazurelle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Louis Mourier
City
Colombes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DUBERTRET Caroline, Pr
Facility Name
Centre Hospitalier Georges Mazurelle
City
La Roche-sur-Yon
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier BONNOT

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lost Children Society (LCS), Online Therapeutic Tabletop Role-playing Game for Early-onset Schizophrenia Patients

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