- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07688798
Mentalization and Social Cognition in Adolescents After Suicide Attempt (MENTACOG-TS)
This study investigates the risk of violent suicide attempts in adolescents, with a particular focus on social cognition and sleep disturbances, to better understand the cognitive and behavioral mechanisms involved and to inform more targeted prevention strategies.
Violent suicide attempts are defined as the use of methods with a high immediate lethal potential. They are associated with distinct clinical profiles and specific risk factors, including an increased risk of recurrence and completed suicide.
Although the association between suicidal behavior and psychiatric disorders is well established, evidence regarding the underlying neurocognitive factors remains inconsistent. In particular, little is known about the role of social cognition in suicidal risk among adolescents. Research in this area is limited, leaving an important gap in our understanding of the cognitive processes that may contribute to the emergence of suicidal thoughts and behaviors during adolescence.
In addition, studies conducted in community-based adolescent cohorts have shown that insufficient sleep duration is independently associated with increased suicidal ideation and suicidal behavior, even after accounting for depressive symptoms.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Catherine Grosmaitre, PhD
- Telefonní číslo: 033144494561
- E-mail: catherine.grosmaitre@aphp.fr
Studijní záloha kontaktů
- Jméno: Hélène Morel
- E-mail: helene.morel@aphp.fr
Studijní místa
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Paris, Francie, 75015
- Hôpital Necker-Enfants Malades
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Kontakt:
- Catherine Grosmaitre, PhD
- Telefonní číslo: 033144494561
- E-mail: catherine.grosmaitre@aphp.fr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Adolescents aged 12 to 16 years, inclusive
- Having made a violent or non-violent suicide attempt
- Hospitalized in the Department of Child and Adolescent Psychiatry at Necker Children's Hospital
- No intellectual disability (IQ > 70)
- Sufficient proficiency in French to complete the study assessments; at least one parent or legal guardian must also have sufficient proficiency in French
- Written informed consent obtained from the holders of parental authority and assent obtained from the adolescent
- Covered by a health insurance scheme
Exclusion Criteria:
- Current psychotic disorder or documented history of a psychotic disorder
- Current manic or hypomanic episode
- Severe neurological or medical condition likely to significantly affect cognitive performance
- Moderate-to-severe substance use disorder requiring specialized treatment
- Acute intoxication or withdrawal state at the time of assessment- Written informed consent obtained from parents or legal guardians and assent obtained from the adolescent
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Adolescents who have attempted violent suicide
Adolescents aged 12 to 16 inclusive who have attempted violent suicide and are hospitalized at Necker Children's Hospital :
And their parents. |
Clinical Assessment of Social Cognition, including :
To explore the associations between performance on the most discriminative social cognition measures (derived from the Clinical Assessment of Social Cognition [ClaCoS] battery) and several secondary variables that may influence socio-cognitive functioning or the characteristics of the suicide attempt, including:
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Experimentální: Adolescents who have attempted nonviolent suicide
Adolescents aged 12 to 16 inclusive who have attempted non-violent suicide (low or moderate lethality means) and are hospitalized at Necker Children's Hospital and matched with adolescents who have attempted violent suicide according to three control variables: gender, main psychiatric diagnosis, and socio-economic precariousness (binary score from a validated scale). And their parents. |
Clinical Assessment of Social Cognition, including :
To explore the associations between performance on the most discriminative social cognition measures (derived from the Clinical Assessment of Social Cognition [ClaCoS] battery) and several secondary variables that may influence socio-cognitive functioning or the characteristics of the suicide attempt, including:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Level of performance in social cognition in the two groups of adolescents hospitalized following a suicide attempt, distinguishing: adolescents who made a violent suicide attempt and those who made a non-violent suicide attempt
Časové okno: 1 day
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Social cognition will be assessed using three subtests from the Clinical Assessment of Social Cognition (ClaCoS) battery.
The PERSO task evaluates social reasoning through the interpretation of social situations and yields a total score based on the number of correct responses.
The MASC (Movie for the Assessment of Social Cognition) assesses theory of mind using a video-based task and provides a total score corresponding to the number of correctly inferred mental states.
The AIHQ assesses attributional biases in ambiguous social situations and generates scores reflecting hostile and intentionality attribution biases.
For all three measures, scores will be analysed as continuous variables, with higher scores indicating better social cognitive performance (PERSO, MASC) or stronger attributional biases (AIHQ).
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1 day
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Severity of suicidal intention
Časové okno: 1 day
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Measurement of the severity of suicidal intention by the Suicide Intent Scale (SIS) rated by the service psychologist based on information collected in the clinical file in the two groups of adolescents hospitalized following a suicide attempt, distinguishing: adolescents who made a violent suicide attempt and those who made a non-violent suicide attempt.
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1 day
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Level of socio-economic precariousness
Časové okno: 1 day
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Level of precariousness and social vulnerability score using the EPICES questionnaire in the two groups of adolescents hospitalized following a suicide attempt, distinguishing: adolescents who made a violent suicide attempt and those who made a non-violent suicide attempt.
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1 day
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Level of anxiety
Časové okno: 1 day
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Level of anxiety assessed using the Screen for Child Anxiety Related Emotional Disorders (SCARED), a self-report questionnaire measuring specific and generalized anxiety symptoms in the two groups of adolescents hospitalized following a suicide attempt, distinguishing: adolescents who made a violent suicide attempt and those who made a non-violent suicide attempt.
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1 day
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Level of depressive disorder
Časové okno: 1 day
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Assessment of depression by the Major Depressive Disorder (MDD) section of the K-SADS (Kiddie Schedule for Affective Disorders and Schizophrenia), a semi-structured interview tool used to diagnose a major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders criteria in the two groups of adolescents hospitalized following a suicide attempt, distinguishing: adolescents who made a violent suicide attempt and those who made a non-violent suicide attempt.
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1 day
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Evaluation of attachment styles
Časové okno: 1 day
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Evaluation of attachment styles, assessed by a self-reported questionnaire, the Adolescent Relationship Scale Questionnaire (ARSQ), in order to examine the quality of emotional bonds and perceived relational security in the two groups of adolescents hospitalized following a suicide attempt, distinguishing: adolescents who made a violent suicide attempt and those who made a non-violent suicide attempt.
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1 day
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Level of sleep disturbances
Časové okno: 1 day
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Sleep disturbances assessed using the Sleep Disturbance Scale for Children (SDSC), a 26-item caregiver-report questionnaire rated on a 5-point Likert scale.
Total scores range from 26 to 130, with higher scores indicating greater sleep disturbance.
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1 day
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Evaluation of socio-developmental / social-cognition skills
Časové okno: 1 day
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Everyday socio-cognitive skills are assessed using the Socio-developmental Skills Questionnaire (SOCODEV), a 20-item parent-completed questionnaire evaluating mentalization, emotion recognition, social motivation, and prosocial behaviors.
Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always).
Total scores range from 20 to 100, with higher scores indicating better socio-developmental skills.
SOCODEV total scores are compared between adolescents hospitalized following a violent versus a non-violent suicide attempt.
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1 day
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Severity of nightmares
Časové okno: 1 day
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Nightmare severity assessed using the Disturbing Dreams and Nightmare Severity Index (DDNSI).
Total scores range from 0 to 37, with higher scores indicating greater nightmare severity.
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1 day
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Catherine Grosmaitre, PhD, Assistance Publique - Hôpitaux de Paris
- Ředitel studie: Pauline MD, PhD Chaste, Assistance Publique - Hôpitaux de Paris
Publikace a užitečné odkazy
Obecné publikace
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- Bachmann S. Epidemiology of Suicide and the Psychiatric Perspective. Int J Environ Res Public Health. 2018 Jul 6;15(7):1425. doi: 10.3390/ijerph15071425.
- Paus T, Keshavan M, Giedd JN. Why do many psychiatric disorders emerge during adolescence? Nat Rev Neurosci. 2008 Dec;9(12):947-57. doi: 10.1038/nrn2513. Epub 2008 Nov 12.
- Asberg M, Traskman L, Thoren P. 5-HIAA in the cerebrospinal fluid. A biochemical suicide predictor? Arch Gen Psychiatry. 1976 Oct;33(10):1193-7. doi: 10.1001/archpsyc.1976.01770100055005.
- Beautrais AL. Suicide and serious suicide attempts in youth: a multiple-group comparison study. Am J Psychiatry. 2003 Jun;160(6):1093-9. doi: 10.1176/appi.ajp.160.6.1093.
- Levi-Belz Y, Beautrais A. Serious Suicide Attempts. Crisis. 2016 Jul;37(4):299-309. doi: 10.1027/0227-5910/a000386. Epub 2016 Jun 1.
- Sastre-Buades A, Alacreu-Crespo A, Courtet P, Baca-Garcia E, Barrigon ML. Decision-making in suicidal behavior: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2021 Dec;131:642-662. doi: 10.1016/j.neubiorev.2021.10.005. Epub 2021 Oct 5.
- Szeifert N, Balint L, Sebok B, Gonda X. Risk factors for violent suicide attempts: Hungarian cross-sectional study. Eur Psychiatry. 2025 Jun 11;68(1):e85. doi: 10.1192/j.eurpsy.2025.10042.
- Pompili M, Innamorati M, Forte A, Longo L, Mazzetta C, Erbuto D, Ricci F, Palermo M, Stefani H, Seretti ME, Lamis DA, Perna G, Serafini G, Amore M, Girardi P. Insomnia as a predictor of high-lethality suicide attempts. Int J Clin Pract. 2013 Dec;67(12):1311-6. doi: 10.1111/ijcp.12211.
- Perrain R, Dardennes R, Jollant F. Risky decision-making in suicide attempters, and the choice of a violent suicidal means: an updated meta-analysis. J Affect Disord. 2021 Feb 1;280(Pt A):241-249. doi: 10.1016/j.jad.2020.11.052. Epub 2020 Nov 12.
- Parrish EM, Steenkamp L, Chalker SA, Moore RC, Pinkham A, Depp CA. Systematic Review of the Link Between Social Cognition and Suicidal Ideation and Behavior in People With Serious Mental Illness. Schizophr Bull Open. 2024 Mar 27;5(1):sgae007. doi: 10.1093/schizbullopen/sgae007. eCollection 2024 Jan.
- Mendle, J. (2014). Why Puberty Matters for Psychopathology. Child Development Perspectives, 8(4), 218-222. https://doi.org/10.1111/cdep.12092
- Oliphant RYK, Smith EM, Grahame V. What is the Prevalence of Self-harming and Suicidal Behaviour in Under 18s with ASD, With or Without an Intellectual Disability? J Autism Dev Disord. 2020 Oct;50(10):3510-3524. doi: 10.1007/s10803-020-04422-6.
- Mikami K, Inomata S, Hayakawa N, Ohnishi Y, Enseki Y, Ohya A, Haruki Y, Kishi Y, Shinohara Y, Ichimura A, Matsumoto H. Frequency and clinical features of pervasive developmental disorder in adolescent suicide attempts. Gen Hosp Psychiatry. 2009 Mar-Apr;31(2):163-6. doi: 10.1016/j.genhosppsych.2008.12.003. Epub 2009 Feb 1.
- MacPherson HA, Kim KL, Seymour KE, Wolff J, Esposito-Smythers C, Spirito A, Dickstein DP. Cognitive Flexibility and Impulsivity Deficits in Suicidal Adolescents. Res Child Adolesc Psychopathol. 2022 Dec;50(12):1643-1656. doi: 10.1007/s10802-022-00952-y. Epub 2022 Jun 25.
- Lubbert M, Bahlmann L, Sobanski T, Schulz A, Kastner UW, Walter M, Jollant F, Wagner G. Investigating the Clinical Profile of Suicide Attempters Who Used a Violent Suicidal Means. J Clin Med. 2022 Dec 2;11(23):7170. doi: 10.3390/jcm11237170.
- Levi-Belz Y, Gvion Y, Horesh N, Fischel T, Treves I, Or E, Stein-Reisner O, Weiser M, David HS, Apter A. Mental pain, communication difficulties, and medically serious suicide attempts: a case-control study. Arch Suicide Res. 2014;18(1):74-87. doi: 10.1080/13811118.2013.809041.
- Larson T, Lundstrom S, Nilsson T, Selinus EN, Rastam M, Lichtenstein P, Gumpert CH, Anckarsater H, Kerekes N. Predictive properties of the A-TAC inventory when screening for childhood-onset neurodevelopmental problems in a population-based sample. BMC Psychiatry. 2013 Sep 25;13:233. doi: 10.1186/1471-244X-13-233.
- Kwon SJ, Turpyn CC, Duell N, Telzer EH. Neural Underpinnings of Social Contextual Influences on Adolescent Risk-Taking. Curr Addict Rep. 2020 Sep;7(3):413-420. doi: 10.1007/s40429-020-00328-6. Epub 2020 Sep 1.
- Kwak CW, Ickovics JR. Adolescent suicide in South Korea: Risk factors and proposed multi-dimensional solution. Asian J Psychiatr. 2019 Jun;43:150-153. doi: 10.1016/j.ajp.2019.05.027. Epub 2019 May 24.
- Kim HS, Shin NY, Jang JH, Kim E, Shim G, Park HY, Hong KS, Kwon JS. Social cognition and neurocognition as predictors of conversion to psychosis in individuals at ultra-high risk. Schizophr Res. 2011 Aug;130(1-3):170-5. doi: 10.1016/j.schres.2011.04.023. Epub 2011 May 26.
- Impey M, Heun R. Completed suicide, ideation and attempt in attention deficit hyperactivity disorder. Acta Psychiatr Scand. 2012 Feb;125(2):93-102. doi: 10.1111/j.1600-0447.2011.01798.x. Epub 2011 Nov 25.
- Hurtig T, Taanila A, Moilanen I, Nordstrom T, Ebeling H. Suicidal and self-harm behaviour associated with adolescent attention deficit hyperactivity disorder-a study in the Northern Finland Birth Cohort 1986. Nord J Psychiatry. 2012 Oct;66(5):320-8. doi: 10.3109/08039488.2011.644806. Epub 2012 Jan 16.
- Hu C, Jiang W, Huang J, Lin J, Huang J, Wang M, Xie J, Yuan Y. The amplitude of low-frequency fluctuation characteristics in depressed adolescents with suicide attempts: a resting-state fMRI study. Front Psychiatry. 2023 Jul 28;14:1228260. doi: 10.3389/fpsyt.2023.1228260. eCollection 2023.
- Hospitalisations pour gestes auto-infligés : une progression inédite chez les adolescentes et les jeunes femmes en 2021 et 2022 | Direction de la recherche, des études, de l'évaluation et des statistiques. (s. d.). https://drees.solidarites-sante.gouv.fr/240516_ERHospiGestesAutoInfliges
- Gvion Y. Aggression, impulsivity, and their predictive value on medical lethality of suicide attempts: A follow-up study on hospitalized patients. J Affect Disord. 2018 Feb;227:840-846. doi: 10.1016/j.jad.2017.11.033. Epub 2017 Nov 20.
- Goldston DB, Daniel SS, Erkanli A, Reboussin BA, Mayfield A, Frazier PH, Treadway SL. Psychiatric diagnoses as contemporaneous risk factors for suicide attempts among adolescents and young adults: developmental changes. J Consult Clin Psychol. 2009 Apr;77(2):281-90. doi: 10.1037/a0014732.
- Fitzgerald C, Dalsgaard S, Nordentoft M, Erlangsen A. Suicidal behaviour among persons with attention-deficit hyperactivity disorder. Br J Psychiatry. 2019 Jun 7:1-6. doi: 10.1192/bjp.2019.128. Online ahead of print.
- Dervic K, Brent DA, Oquendo MA. Completed suicide in childhood. Psychiatr Clin North Am. 2008 Jun;31(2):271-91. doi: 10.1016/j.psc.2008.01.006.
- Comparelli A, Corigliano V, Montalbani B, Nardella A, De Carolis A, Stampatore L, Bargagna P, Forcina F, Lamis D, Pompili M. Building a neurocognitive profile of suicidal risk in severe mental disorders. BMC Psychiatry. 2022 Sep 26;22(1):628. doi: 10.1186/s12888-022-04240-3.
- Cheng W, Rolls E, Gong W, Du J, Zhang J, Zhang XY, Li F, Feng J. Sleep duration, brain structure, and psychiatric and cognitive problems in children. Mol Psychiatry. 2021 Aug;26(8):3992-4003. doi: 10.1038/s41380-020-0663-2. Epub 2020 Feb 3.
- Bruno S, Anconetani G, Rogier G, Del Casale A, Pompili M, Velotti P. Impulsivity traits and suicide related outcomes: A systematic review and meta-analysis using the UPPS model. J Affect Disord. 2023 Oct 15;339:571-583. doi: 10.1016/j.jad.2023.07.086. Epub 2023 Jul 17.
- Bilsen J. Suicide and Youth: Risk Factors. Front Psychiatry. 2018 Oct 30;9:540. doi: 10.3389/fpsyt.2018.00540. eCollection 2018.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci nervového systému
- Duševní poruchy
- Poruchy spánku a bdění
- Parasomnie
- Kvalita zdravotní péče, přístup a hodnocení
- Vyšetřovací techniky
- Epidemiologické metody
- Sběr dat
- Mechanismy hodnocení zdravotní péče
- Kvalita zdravotní péče
- Veřejné zdraví
- Životní prostředí a veřejné zdraví
- Průzkumy a dotazníky
Další identifikační čísla studie
- APHP251891
- 2025-A02756-43 (Jiný identifikátor: ID RCB number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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