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NCT Number: NCT06921226

Exploratory Analysis of Interpersonal and Intrapersonal Psychological Processes Implied in Risk-taking and Suicidal Behaviors, in Adult and Adolescent At-risk

In a recent report, Santé Publique France (2023), reported that 4.2% of 18-85 year-olds had thought about suicide in the last 12 months, and 6.8% had attempted suicide in their lifetime and 0.5% in the last year. Even more recently, the DREES (Direction de la recherche, des études, de l'évaluation et des statistiques auprès des Ministères Sociaux) published a report on May 16, 2024, showing a sharp rise in hospitalization rates for self-inflicted acts among female patients aged between 10 and 24, with a peak around age 15. Two-thirds of these hospitalizations for self-inflicted injuries are related to deliberate drug intoxication. Depression, bipolar disorders and schizophrenia spectrum disorders (among other psychological disorders) are known risk factors for suicide, which is the leading cause of death in this clinical context. In addition to these formalized psychopathological elements, risk behaviors underpinned by psychological processes common to suicide attempts are suspected and need to be studied in depth.

Research into psychiatry and the psychopathology of suicide has identified a number of risk and protective factors. These psychological determinants - or processes - act alongside other key factors such as the environment and social ties. Life contexts can have an impact on health, and more specifically on the psychopathology of individuals, through disturbances of a biological, psychological and social nature. It is important to be able to describe what processes are at work and how they explain the development and maintenance of behaviours that put one's life and health at risk. This is part of a preventive approach to mental health. We suggest that the study of psychological processes such as suicidal ruminations, impulsivity and interpersonal needs (e.g. the interpersonal theory of suicide) is necessary to understand their involvement in risk-taking and suicidal behavior. To our knowledge, few studies of this type are underway in France, particularly with vulnerable clinical populations (adolescents/adults). The inclusion of a process-centered approach (Kinderman, 2015), in a transdiagnostic and preventive way, constitutes an innovative approach.

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Key information

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Métropole Savoie, Chambéry, Savoie, France

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About this study

The aim of this study is to describe psychological processes that contribute to risk-taking and suicidal behaviors.

The primary objective of this study is: To examine the fit of an Structural Equation Model (SEM) of risk-taking and suicidal behaviors and ideation, and explain those self-destructive behavior can possibly affected by Perceived Burdensomeness (PB) and Thwarted Belongingness (TB), Impulsivity and Suicidal Ruminations (SR) among with suicidal ideations.

This study will address the following secondary objectives:

  • To explore the mediating effect of risk-taking, as a behavioral variable, on the relationship between suicidal ideation and behavior and impulsivity.
  • To explore the mediating effect of risk-taking, as a self-reported variable, on the relationship between suicidal ideation and behavior and impulsivity.
  • To explore the mediating effect of risk-taking, as a cognitive variable, on the relationship between suicidal ideation and behavior and impulsivity.
  • To explore the mediating effect of PB on the relationship between SR and suicidal ideation and behavior.
  • To explore the mediating effect of TW, on the relationship between SR and suicidal ideation and behavior.
  • To explore the mediating effect of SR on the relationship between suicidal ideation and behavior and impulsivity.

The effect of developmental status (adult versus adolescent), will be considerated as a co-variate.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 12-65 years
  • Adolescent population considered as at risk in mental health : admitted to the peadiatric department (CHMS).

or - Adult population : user of the Espoir73 association (an association for adults with a mental health problem) or users of SM@RT (CHS, a psycho-social rehabilitation center for adults with a mental illness).

Exclusion criteria

  • No suicidal ideation or behaviors (none " Yes " response at the 6 questions of the C-SSRS screen version).

Treatment and study plan

Psychological Processes

Other
  • The sense of thwarted belonging and perceived burden will be measured using the Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012). The back-translated French version by Landrault et al. (2019) will be used. This scale is based on a seven-point Likert scale, ranging from 1 (not at all true for me) to 7 (very true for me).
  • To assess impulsivity, we will use the short version of the UPPS validated in French by Billieux and colleagues (2012). It comprises 20 items divided into 5 dimensions (negative urgency, positive urgency, lack of premeditation, lack of perseverance and sensation seeking). Participants were asked to respond on a Likert scale from 1 ("I strongly agree") to 4 ("I strongly disagree").
  • We will use the French version of the SRS (Suicidal Rumination Scale, Rogers et al., 2022), back-translated for this study. This eight-item scale assesses suicidal ruminations.

Risk-taking variables

Other
  • One of the behavioral tasks based on a real-life model of risky decision-making is BART (Lejuez et al., 2002, 2007). It is based on a conceptual framework of balance between reward and loss potential (Leigh, 1999; Lejuez et al., 2002).
  • We will measure one of the cognitive aspects of risk-taking behavior, especially the general cognitive decision-making styles (GDMS, from Scott and Bruce, 1995; Gerard et al., 2016).
  • We will measure negative (NRTB , Duell et al., 2020) and positive (PRTB, Fryts et al., 2024) self-reported risk-taking behaviour.

Suicidal ideation and behavior

Other

Suicidal ideation and behavior were measured using the screening grid, the Columbia Suicide Severity Rating Scale (C-SSRS screen version, Posner, Brown, Stanley et al., 2011). It is composed of 6 questions, which take into account the potential method of suicide, the presence of suicidal intent and/or ideation with a plan or intention. This scale has high reliability and validity in general paediatric emergencies (Scudder et al., 2023) and psychiatric samples (Campos et al., 2023).

It classifies people as being at low or high risk of suicide, based on the presence or absence of significant active suicidal ideation in the last three months.

Primary outcomes

  1. Suicidal ideation and behaviors

    Time frame: At inclusion

    C-SSRS score (screen version) out of 6

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Collaborators

  • Centre Hospitalier Spécialisé de la Savoie (Chambéry)
  • Université Savoie Mont Blanc

Registry information

Official study title

Intra-personal and Interpersonal Psychological Processes Involved in Risk-taking and Suicidal Behaviors Among Vulnerable Adolescents and Adults

Acronym: RISKY

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 10, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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