Centre Hospitalier Guillaume Regnier
Rennes, 35700, France
Location status: Recruiting
Location contact
Nathalie Alleton
CONTACT
+332 22 51 41 21 ext. +33
Valerie CHAUVEL
CONTACT
+332 99 33 39 18 ext. +33
NCT Number: NCT07831681
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.
Interested in participating?
Request Info12 year–17 year
All sexes
Observational
Rennes, 35700, France
Location status: Recruiting
Nathalie Alleton
CONTACT
+332 22 51 41 21 ext. +33
Valerie CHAUVEL
CONTACT
+332 99 33 39 18 ext. +33
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Time frame: From enrollment until last assessment : 1 year
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.
Contact information is provided by the study sponsor or research team.
Nathalie ALLETON
CONTACT
+332 22 51 41 21 ext. +33
Valerie CHAUVEL
CONTACT
+332 99 33 39 18 ext. +33
Hospital Center Guillaume Régnier
Other
Acronym: ICPA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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