The Impact of a Collaborative Therapeutic Game in the Management of Psychiatric Symptoms in Adolescents (ICPA)

When faced with psychiatric symptoms-which are characterized, in particular, by a unique perception of one's environment, the intentions of others, or events- the investigators now know that early intervention is crucial. For adults, there is a therapeutic tool in the form of a collaborative game that helps patients better understand and cope with these symptoms. A version of this game adapted for adolescents has been created: "L'océan des possibles" in French which is translated in English in "The Ocean of possibilities" (that term will be used throughout the rest of the protocol). It is used as part of a support group at the Guillaume Regnier Hospital Center.

The objective of the study is to examine in detail the impact of this game on psychiatric symptoms and patients' perceptions of those symptoms by comparing it with the impact of other types of treatment. To this end, during follow-up interviews regarding the proposed treatments, the standard assessment interview will be supplemented with additional questionnaires. The investigators plan to include 16 adolescents, aged 12 to 17, with 8 in the treatment group using the game and 8 receiving another type of treatment.

The patients will receive care tailored to their needs from the investigators' healthcare teams.

The patients participation in this study will last 1 year and will involve:

• an enrollment visit
• 2 scheduled follow-up visits (3 months and 6 months after the end of treatment) These visits will take place during the routine follow-up appointments held just before the start of treatment, and 3 months and 6 months after the end of treatment. Additional assessments, consisting of questionnaires and standardized scales, will be conducted to analyze The patients' symptoms, their awareness of their difficulties ("insight"), their executive functioning, and their social and interpersonal skills in greater detail.

The pre-treatment assessment should take about 1 hour and 20 minutes, and the following two assessments about 1 hour and 45 minutes each. The duration of these assessments may be adjusted, with the option to complete part of the questionnaires on their own after the interview.

Study Overview

• Status: Recruiting
• Conditions: Teenager; Psychiatric Condition; Psychiatric Symptoms
• Intervention / Treatment: Behavioral: Playing a collaborative and therapeutic game

• Study Type: Observational
• Enrollment (Estimated): 16

Contacts and Locations

• Study Contact: Name: Nathalie ALLETON; Phone Number: +33 +332 22 51 41 21; Email: driri@ch-guillaumeregnier.fr
• Study Contact Backup: Name: Valerie CHAUVEL; Phone Number: +33 +332 99 33 39 18; Email: v.chauvel@ch-guillaumeregnier.fr

Study Locations

• France
  • Rennes, France, 35700
    • Recruiting
    • Centre Hospitalier Guillaume Regnier
    • Contact: Valerie CHAUVEL; Phone Number: +33 +332 99 33 39 18; Email: v.chauvel@ch-guillaumeregnier.fr
    • Contact: Nathalie Alleton; Phone Number: +33 +332 22 51 41 21; Email: driri@ch-guillaumeregnier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Teenagers with psychotic symptoms that are treated in the child and adolescent psychiatry clinic.

Description

Inclusion Criteria:

• Teenager from 12 to 17 receiving outpatient care in childrens' and teenagers' psychiatrie unit
• Patients with psychotic symptoms (delusions, hallucinations) and thought rigidity assessed using scales (SIPS, K-SADS, SDQ)
• A patient enrolled in or eligible for a social security program
• Patients and parents who have received informed information about the study and have signed a consent form to participate in the study

Exclusion Criteria:

- Patients with a previous diagnosis of Autism Spectrum Disorder

Study Plan

How is the study designed?

Design Details

• Observational Models: CASE_ONLY
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group "The ocean of possibilities"; Group that will play the collaborative and thepaeutic game	Behavioral: Playing a collaborative and therapeutic game; Upon inclusion, the patient will be evaluated based on the following assessments : CAPS, PDI-21 and LSHS, Ment-S, MCQ-30, R-CMAS, NEPSY-II, BRIEF, EASE and Achim's theory of mind tests. The patient will be apart of a group that will play the collaborative therapeutic game for 12 to 15 weeks with 1 game per week. 3 months after and 6 months after the patient will be evaluated based on the following assessments : CAPS, PDI-21 and LSHS, Ment-S, MCQ-30, R-CMAS, NEPSY-II, BRIEF, EASE and Achim's theory of mind tests.
Control group; Group that will not be playing the collaborative and thepaeutic game

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patients' Hallucinatory Experiences	The patient will be assessed using the Launay Slade Hallucinations Scale (LSHS) before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention. Each item is scored on a scale of 0 to 4. The overall score ranges from 0 to 48. A high score indicates a greater predisposition to hallucinatory experiences.	From enrollment until last assessment : 1 year
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patients' metacognition.	The patient will be assessed using the Short french Meta-Cognitions Questionnaire (MCQ-30) before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention. Each item is scored on a scale of 1 to 4.The overall score ranges from 30 to 120 points.- The higher the score, the more rigid and pathogenic the metacognitive processes are considered to be.	From enrollment until last assessment : 1 year
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patients' unusual perceptions	The patient will be assessed using the Cardiff Anomalous Perceptions Scale (CAPS) before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention.Each item is scored on a binary scale (0 = No / 1 = Yes). The overall score ranges from 0 to 32.The higher the score, the more severe and prevalent the participant's abnormal perceptual experiences and hallucinations are.	From enrollment until last assessment : 1 year
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patients' propensity for delusional ideas.	The patient will be assessed using the Peter's Delusions Inventory - 21 items (PDI-21) before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention. Each item is scored on a scale of 1 to 4.The overall score ranges from 21 to 84 points.The higher the score, the greater the propensity for delusional ideas.	From enrollment until last assessment : 1 year
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patients' capacity for mentalization.	The patient will be assessed using the Mentalization Scale (Ment-S) before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention. Each item is scored on a scale of 1 to 5. The overall score ranges from 28 to 140 points.The higher the score, the more developed the person's capacity for mentalization.	From enrollment until last assessment : 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patients' social awareness.	The patient will be assessed using the EASE scale (Examination of Anomalous Self-Experience. ) before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention.There are 50 questions, intended for parents. Each item is scored on a scale of 0 to 2. Overall score from 0 to 100 points. - The higher the score, the better the child masters the rules of social interaction and demonstrates an excellent ability to understand the intentions and emotions of others.	From enrollment until last assessment : 1 year
Measure the anxiety impact of the collaborative therapeutic game "The Ocean of possibilities" on patients	The patient will be assessed using the Revised Children Manifest Anxiety Scale (R-CMAS) questionnaire before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention. Each item is scored on a binary scale( 0 = No / 1 = Yes). The overall anxity score ranges from 0 to 28. A high score indicates that the child is suffering from significant generalized anxiety.	From enrollment until last assessment : 1 year
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patients' social cognition	The patient will be assessed using the Combined Stories Task (COST), before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention.The test includes 26 questions on mentalization, 6 questions on non-social reasoning, and 30 questions on control. Each item is scored on a scale of 0 to 1. For the QM score (Mentalization): The higher the score, the greater the ability to understand others' thoughts, hidden intentions, and emotions. For the QR score (Reasoning): The higher the score, the more intact the individual's logic and reasoning are when faced with physical or material situations. For the QC score (Control): The higher the score, the better the individual's attention, concentration, and working memory are maintained during the test.	From enrollment until last assessment : 1 year
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patients' executive functions	The patient will be assessed using the Behavior Rating Inventory of Executive Function (BRIEF) before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention. Each item is rated on a scale of 1 to 3 (1 = never, 2 = sometimes, 3 = often). The overall score ranges from 86 to 258. A high score indicates a greater degree of dysfunction or impairment in executive functions in daily life.	From enrollment until last assessment : 1 year
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patients' cognitive flexibility	The patient will be assessed using the "categorization" subtest of the Developmental Neuropsychological Assessment, Second Edition (NEPSY ii), before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention. The raw score is determined by the number of correct categories and the number of errors. It is then converted to a Standard Score (SS) using the conversion tables in the manual (NEPSYii). The standard score (SS) ranges from 1 to 19.A standard score between 8 and 12 means that cognitive flexibility is average for the patient's age.The lower the standard score(SS below 12), the lower the patient's cognitive flexibility. The higher the standard score (SS above 12), the better the cognitive flexibility.	From enrollment until last assessment : 1 year
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patient's inhibitory abilities	The patient will be assessed using the "Inhibition" subtest of the Developmental Neuropsychological Assessment, Second Edition (NEPSY ii), before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention. The raw score is determined by the number of errors and the time in seconds required. This score is converted to a Standard Score (SS) using the conversion tables in the manual (NEPSYii). The standard score ranges from 1 to 19. A standard score between 8 and 12 means that inhibitory abilities is average for the patient's age.The lower the standard score (below 12), the lower the patient's inhibitory abilities.The higher the standard score (above 12), the better the inhibitory abilities.	From enrollment until last assessment : 1 year
Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patient's verbal fluency	The patient will be assessed using the "Word Generation" subtest of the Developmental Neuropsychological Assessment, Second Edition (NEPSY ii), before intervention, 3 months (more or less 15 days) after and 6 months (more or less 15 days) after the end of the intervention. The raw score is determined by the number of correct words. This score is converted to a Standard Score (SS) using the conversion tables in the manual (NEPSYii). The standard score ranges from 1 to 19. A standard score between 8 and 12 means that verbal fluency is average for the patient's age.The lower the standard score (below 12), the lower the patient's verbal fluency.The higher the standard score (above 12), the better the verbal fluency.	From enrollment until last assessment : 1 year

Collaborators and Investigators

• Sponsor: Hospital Center Guillaume Régnier

Publications and helpful links

General Publications

• Wykes T, Reeder C, Landau S, Everitt B, Knapp M, Patel A, Romeo R. Cognitive remediation therapy in schizophrenia: randomised controlled trial. Br J Psychiatry. 2007 May;190:421-7. doi: 10.1192/bjp.bp.106.026575.
• Kumra S, Charles Schulz S. Editorial: research progress in early-onset schizophrenia. Schizophr Bull. 2008 Jan;34(1):15-7. doi: 10.1093/schbul/sbm123. Epub 2007 Nov 28.
• Morrison AP, French P, Walford L, Lewis SW, Kilcommons A, Green J, Parker S, Bentall RP. Cognitive therapy for the prevention of psychosis in people at ultra-high risk: randomised controlled trial. Br J Psychiatry. 2004 Oct;185:291-7. doi: 10.1192/bjp.185.4.291.
• Marshall M, Rathbone J. Early intervention for psychosis. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD004718. doi: 10.1002/14651858.CD004718.pub3.
• Ueland T, Rund BR. A controlled randomized treatment study: the effects of a cognitive remediation program on adolescents with early onset psychosis. Acta Psychiatr Scand. 2004 Jan;109(1):70-4. doi: 10.1046/j.0001-690x.2003.00239.x.
• Turner DT, van der Gaag M, Karyotaki E, Cuijpers P. Psychological interventions for psychosis: a meta-analysis of comparative outcome studies. Am J Psychiatry. 2014 May;171(5):523-38. doi: 10.1176/appi.ajp.2013.13081159.
• Mignot, T., Bazille, M.-T., Bernardin, F., Schwan, R., & Laprevote, V. (2018). Le Centre de liaison et d'intervention précoce (CLIP) : L'exemple nancéien d'un partenariat avec la Maison des adolescents dans la prise en charge précoce des psychoses émergentes. Information psychiatrique, 94.
• Medjkane, F., & Jardri, R. (2019). 15. Schizophrénies à début précoce et très précoce. In Les schizophrénies (p. 103-111). Lavoisier; Cairn.info. https://www.cairn.info/les-schizophrenies--9782257207395-p-103.htm
• McGorry PD, Yung AR, Phillips LJ, Yuen HP, Francey S, Cosgrave EM, Germano D, Bravin J, McDonald T, Blair A, Adlard S, Jackson H. Randomized controlled trial of interventions designed to reduce the risk of progression to first-episode psychosis in a clinical sample with subthreshold symptoms. Arch Gen Psychiatry. 2002 Oct;59(10):921-8. doi: 10.1001/archpsyc.59.10.921.
• Larøi, F., Van Der Linden, M., & Goëb, J.-L. (2009). Hallucinations et idées délirantes chez les enfants et adolescents : Mise en perspective avec les travaux réalisés chez l'adulte. Neuropsychiatrie de l'Enfance et de l'Adolescence, 57(1), 32-37. https://doi.org/10.1016/j.neurenf.2008.05.005
• Khazaal Y, Favrod J, Azoulay S, Finot SC, Bernabotto M, Raffard S, Libbrecht J, Dieben K, Levoyer D, Pomini V. "Michael's Game," a card game for the treatment of psychotic symptoms. Patient Educ Couns. 2011 May;83(2):210-6. doi: 10.1016/j.pec.2010.05.017. Epub 2010 Jun 19.
• Khazaal Y, Chatton A, Dieben K, Huguelet P, Boucherie M, Monney G, Lecardeur L, Salamin V, Bretel F, Azoulay S, Pesenti E, Krychowski R, Costa Prata A, Bartolomei J, Brazo P, Traian A, Charpeaud T, Murys E, Poupart F, Rouviere S, Zullino D, Parabiaghi A, Saoud M, Favrod J. Reducing Delusional Conviction through a Cognitive-Based Group Training Game: A Multicentre Randomized Controlled Trial. Front Psychiatry. 2015 Apr 28;6:66. doi: 10.3389/fpsyt.2015.00066. eCollection 2015.
• Khazaal, Y. (2013). Michael's Game, un jeu d'entraînement au raisonnement par hypothèse : Étude randomisée contrôlée de son impact auprès de patients avec un trouble psychotique. European Psychiatry, 28(S2), 96-96. https://doi.org/10.1016/j.eurpsy.2013.09.257
• Asarnow JR, Tompson MC, McGrath EP. Annotation: childhood-onset schizophrenia: clinical and treatment issues. J Child Psychol Psychiatry. 2004 Feb;45(2):180-94. doi: 10.1111/j.1469-7610.2004.00213.x.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: September 15, 2026
• First Posted (Actual): September 21, 2026

Study Record Updates

• Last Update Posted (Actual): September 21, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: teenager; psychiatric symptoms; collaborative and therapeutic game; management of psychiatric symptoms
• Other Study ID Numbers: RC24_01_VC; 2024-A02720-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Data about study protocol and clinical information will be available on request from other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No