- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05469815
Lost Children Society (LCS), Online Therapeutic Tabletop Role-playing Game for Early-onset Schizophrenia Patients (TTRPG)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Colombes, France
- Hôpital Louis Mourier
-
La Roche-sur-Yon, France
- Centre Hospitalier Georges Mazurelle
-
Nantes, France
- Centre Hospitalier Universitaire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lost Children Society Game
Online therapeutic role-playing session
|
36 online therapeutic role-playing sessions spread over 36 weeks, one session per week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall feasibility of the Game
Time Frame: 10 month
|
Effective participation of the patient - feasibility will be defined by the number of effective sessions > or = 29
|
10 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jonathan PIONNIER, EPSM de Vendée Georges Mazurelle
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHD22_0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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