Understanding and Acting to Regulate Suicidal Behavior

NCT ID: NCT06689657

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2028-07-06

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).

Conditions

Suicidal Ideation; Suicidal Behavior; Self-harm Behavior; Adolescents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Adolescent group therapy (CARES) and parent group therapy (RNV)

In the adolescent group, they will attend 8 group sessions during 1 month (2 sessions/week). There also will be a "boost" session 3 month after the last session.

Parents will attend 4 group sessions during 1 month too (1 session/week). There will be 2 "boost" sessions : 1 month and 3 month after the last session

Patients will be randomized in each group with blinded assessment

Group Type: OTHER

Adolescent group therapy (CARES) and parent group therapy (RNV)

Intervention Type: OTHER

In the adolescent group, they will attend 8 group sessions during 1 month (2 sessions/week). There also will be a "boost" session 3 month after the last session. Parents will attend 4 group sessions during 1 month too (1 session/week). There will be 2 "boost" sessions : 1 month and 3 month after the last session Patients will be randomized in each group with blinded assessment

Adolescent groupe therapy (CARES) only

In the adolescent group, they will attend 8 group sessions during 1 month (2 sessions/week).

There will be a "boost" session 3 month after the last session

Patients will be randomized in each group with blinded assessment

Group Type: EXPERIMENTAL

Cognitive behavioral group therapy for adolescents and non violent resistance group for parents

Intervention Type: BEHAVIORAL

In the adolescents group, this cognitive-behavioral group therapy will include emotion regulation skills, distress tolerance skills, cognitive strategies, work on values and problem-solving strategies

Those sessions will include psychoeducation about adolescents, about suicidal ideation and suicidal behavior, coping with adolescent emotional distress, support on how to be a parent today (screen regulation...) and manage daily life

Interventions

Cognitive behavioral group therapy for adolescents and non violent resistance group for parents

In the adolescents group, this cognitive-behavioral group therapy will include emotion regulation skills, distress tolerance skills, cognitive strategies, work on values and problem-solving strategies

Those sessions will include psychoeducation about adolescents, about suicidal ideation and suicidal behavior, coping with adolescent emotional distress, support on how to be a parent today (screen regulation...) and manage daily life

Intervention Type: BEHAVIORAL

Adolescent group therapy (CARES) and parent group therapy (RNV)

In the adolescent group, they will attend 8 group sessions during 1 month (2 sessions/week). There also will be a "boost" session 3 month after the last session. Parents will attend 4 group sessions during 1 month too (1 session/week). There will be 2 "boost" sessions : 1 month and 3 month after the last session Patients will be randomized in each group with blinded assessment

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Julie CABROL

Role: CONTACT

cares@chu-montpellier.fr

0467337196 ext. +33

Allison GOUJON

Role: CONTACT

cares@chu-montpellier.fr

0467337195 ext. +33

Other Identifiers

RECHMPL22_0339 / UF 8379

Identifier Type: -

Identifier Source: org_study_id