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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05469815
Other study ID # CHD22_0001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date January 1, 2026

Study information

Verified date July 2023
Source Centre Hospitalier Departemental Vendee
Contact Agnès DORION
Phone 251446380
Email agnes.dorion@ght85.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 16
Est. completion date January 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 15 Years to 20 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Lost Children Society Game
36 online therapeutic role-playing sessions spread over 36 weeks, one session per week

Locations

Country Name City State
France Hopital Louis Mourier Colombes
France Centre Hospitalier Georges Mazurelle La Roche-sur-Yon
France Centre Hospitalier Universitaire Nantes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall feasibility of the Game Effective participation of the patient - feasibility will be defined by the number of effective sessions > or = 29 10 month
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