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TeenagerICPANCT07831681

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

An observational study of Teenager and Psychiatric Symptoms, run by Hospital Center Guillaume Régnier at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 17 years
What is being tested?
Playing a collaborative and therapeutic game
How many people
16 participants
Where
1 siteFrance
Study dates
1 Mar 2025to 1 Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • Patients with a previous diagnosis of Autism Spectrum Disorder

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Centre Hospitalier Guillaume Regnier

    Rennes, 35700

    Valerie CHAUVEL, +332 99 33 39 18 ext. +33, v.chauvel@ch-guillaumeregnier.fr

    Nathalie Alleton, +332 22 51 41 21 ext. +33, driri@ch-guillaumeregnier.fr

    Recruiting

Other trials in France

About this study

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.

Read more

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.

Being tested
Playing a collaborative and therapeutic game
Keywords
collaborative and therapeutic game, psychiatric symptoms, teenager, management of psychiatric symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Playing a collaborative and therapeutic gameBehavioural

    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.

Study groups in NCT07831681
Study groupRoleWhat they receive
Group "The ocean of possibilities"Group that will play the collaborative and thepaeutic game
Receives: Behavioral: Playing a collaborative and therapeutic game
Control groupGroup that will not be playing the collaborative and thepaeutic game

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment until last assessment : 1 year

  2. 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.

    Measured: From enrollment until last assessment : 1 year

  3. 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.

    Measured: From enrollment until last assessment : 1 year

  4. 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.

    Measured: From enrollment until last assessment : 1 year

  5. 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.

    Measured: From enrollment until last assessment : 1 year

Secondary outcomes (7)
  1. 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.

    Measured: From enrollment until last assessment : 1 year

  2. 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.

    Measured: From enrollment until last assessment : 1 year

  3. 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.

    Measured: From enrollment until last assessment : 1 year

  4. 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.

    Measured: From enrollment until last assessment : 1 year

  5. 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.

    Measured: From enrollment until last assessment : 1 year

  6. 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.

    Measured: From enrollment until last assessment : 1 year

  7. 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.

    Measured: From enrollment until last assessment : 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study start1 Mar 2025
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07831681
Sponsor's protocol ID
RC24_01_VC
Other IDs
2024-A02720-47
Acronym
ICPA
Status last verified
Sep 2026
First submitted
26 Jun 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data about study protocol and clinical information will be available on request from other researchers.

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.

    PubMed 17470957
  • 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.

    PubMed 14674961
  • 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.

    PubMed 24525715
  • 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.

    PubMed 15458988
  • 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.

    PubMed 12365879
  • Marshall M, Rathbone J. Early intervention for psychosis. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD004718. doi: 10.1002/14651858.CD004718.pub3.

    PubMed 21678345
  • 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

  • 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.

    PubMed 18048380
  • 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.

    PubMed 20646892
  • 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.

    PubMed 25972817
  • 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.

    PubMed 14982235

Questions about this trial

What is this clinical trial studying?

An observational study of Teenager and Psychiatric Symptoms, run by Hospital Center Guillaume Régnier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Valerie CHAUVEL (+332 99 33 39 18 ext. +33, v.chauvel@ch-guillaumeregnier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure the impact of the collaborative therapeutic game "The Ocean of possibilities" on patients' Hallucinatory Experiences (time frame: From enrollment until last assessment : 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07831681, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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