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

April 8, 2025 updated by: Centre Hospitalier Metropole Savoie

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. To explore the mediating effect of risk-taking, as a behavioral variable, on the relationship between suicidal ideation and behavior and impulsivity.
  2. To explore the mediating effect of risk-taking, as a self-reported variable, on the relationship between suicidal ideation and behavior and impulsivity.
  3. To explore the mediating effect of risk-taking, as a cognitive variable, on the relationship between suicidal ideation and behavior and impulsivity.
  4. To explore the mediating effect of PB on the relationship between SR and suicidal ideation and behavior.
  5. To explore the mediating effect of TW, on the relationship between SR and suicidal ideation and behavior.
  6. 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.

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bassens, France, 73000
        • Centre Hospitalier Spécialisé de la Savoie (CHS)
        • Contact:
        • Contact:
          • Nicolas RAINTEAU
      • Francin, France, 73800
    • Savoie
      • Chambery, Savoie, France, 73011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procedure based on questionnaires and a computer task

This study begins with an initial screening phase. Only individuals exhibiting suicidal ideation and/or behavior, as identified by at least one affirmative response out of six on the C-SSRS scale (Posner et al., 2011), will be eligible to proceed with the study.

Subsequently, they will complete seven questionnaires and one computer task:

  • Risk-taking behaviors via a computer task via the Balloon Analogue Risk Task (BART, Lejuez et al., 2002, 2007) and questionnaires (NRTB and PRTB, Duell et al., 2020; Fryts et al., 2024)
  • Decision-making styles (GDMS, Scott and Bruce, 1995)
  • Impulsivity (UPPS-Short, Billieux et al., 2012)
  • Depressive symptoms (CES-D, Fuhrer and Rouillon, 1989)
  • Interpersonal needs (INQ, Landrault et al., 2019)
  • Suicidal ruminations (SRS, Rogers et al., 2022)
Other: Psychological Processes
  • 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.
Other: Risk-taking variables
  • 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.
Other: Suicidal ideation and behavior

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicidal ideation and behaviors
Time Frame: At inclusion
C-SSRS score (screen version) out of 6
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Metropole Savoie

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2025

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHMS24005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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