Understanding and Acting to Regulate Suicidal Behavior

Not Applicable

Not yet recruiting

• Conditions: Suicidal Ideation; Suicidal Behavior; Self-harm Behavior; Adolescents

• Registration Number: NCT06689657
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Data from Santé Publique France show that since the onset of the health crisis (covid-19), there has been an increase in emergency room visits for mood disorders among children under 15 years of age, with a notable rise in the number of visits since early September 2020 compared to previous years. Recent literature considers Dialectical Behavior Therapy (DBT) as the only approach that has demonstrated (albeit weak to moderate) effects on the recurrence of self-harming behaviors. It is within this context, and based on these various findings, that the CARES program was developed (Understanding and Acting to Regulate Emotions and Suicidal Behaviors), aimed at adolescents who have engaged in suicidal behaviors or who have active suicidal ideation.

The objective of this study is to compare the CARES program for adolescents alone to the CARES program for adolescents combined with a parent group using Non-Violent Resistance (NVR) on the occurrence of self-harming behaviors among adolescents who have engaged in suicidal acts and/or have active suicidal ideation, six months after the conclusion of the intervention.

This is a prospective, randomized, open-label, single-center, controlled study with two parallel arms, with blinded assessment of the outcome measures.

Detailed Description

The CARES adolescent program consists of a group intervention with 8 biweekly sessions over a total duration of one month, followed by a booster session 3 months post-intervention. These sessions are conducted by nurses and psychologists trained in Cognitive Behavioral Therapies (CBT). The content of the group aims to provide adolescents with cognitive and behavioral strategies to improve their emotional distress tolerance and to expand their repertoire of solutions in times of emotional crisis.

The CARES adolescent and NVR parent program includes the same adolescent group described above, supplemented by an NVR parent group. This parent group meets once a week for one month (4 sessions), with two additional booster sessions at 1 month and 3 months post-intervention. The content of the parent program is a parent management training composed of strategies for managing their adolescent's emotional crises through emotional regulation techniques based on Non-Violent Resistance (NVR) methods (Omer, 2021).

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14
• Study Start: 2025-01-06
• Primary Completion: 2028-01-06
• Study Completion: 2028-07-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Age from 12 to 16 years 11 months old
• Active suicidal ideation and/or suicidal behavior during the last 6 months
• The patient is referred by a healthcare professional

Exclusion Criteria

• Intellectual developmental disorder
• Non-french speaking
• Planned travel not allowing the complete following of the study
• The patient, the parents or the legal guardian can not be correctly informed
• The patient presents symptoms that prevent him from group interaction (behavior disorders, hallucinations, delirium)
• The family already followed the same kind of program
• The patient is already enrolled in a clinical trial or is taking a treatment off full market approval during 4 weeks before screening
• The patient and the family are not affiliated to any healthcare insurance
• No signed consent from parents or a legual guardian nor one of the parental authority holder
• The patient did not consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurence of suicidal behavior	Variation between initial assessment and assessment 6 month post intervention	Assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)

Secondary Outcome Measures

Name	Time	Method
Clinical improvement assessement (clinician)	Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention	Assessment with the Clinical Global Impression-Improvement (CGI-I)
Parenting stress	Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention	Assessment with the Parenting Stress Index short form (PSI-4-SF)
Parenting anxiety and depression	Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention	Assessment with the Hospital Anxiety and Depression Scale (HADS)
Adolescent depression	Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention	Assessment with the Child Depression Inventory (CDI)
Suicidal ideation	Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention	Assessment with the C-SSRS