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Understanding and Acting to Regulate Suicidal Behavior

Randomized Study of Two Modalities of Cognitive-behavioral Group Therapy in Adolescents with Suicidal Ideation or Suicidal Behavior

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06689657
Acronym
CARES
Enrollment
108
Registered
2024-11-14
Start date
2025-01-06
Completion date
2028-07-06
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescents, Self-harm Behavior, Suicidal Behavior, Suicidal Ideation

Keywords

Suicide prevention, Cognitive-behavioral therapy, Dialectical Behavior Therapy, Non pharmacological intervention, Adolescent

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).

Interventions

BEHAVIORALCognitive 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

OTHERAdolescent 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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Adolescent group therapy (CARES) and parent group therapy (RNV) vs Adolescent groupe therapy (CARES) only

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurence of suicidal behaviorVariation between initial assessment and assessment 6 month post interventionAssessed with the Columbia Suicide Severity Rating Scale (C-SSRS)

Secondary

MeasureTime frameDescription
Clinical improvement assessement (clinician)Variation between initial assessment and post-intervention and between initial assessment and 6 months post-interventionAssessment with the Clinical Global Impression-Improvement (CGI-I)
Parenting stressVariation between initial assessment and post-intervention and between initial assessment and 6 months post-interventionAssessment with the Parenting Stress Index short form (PSI-4-SF)
Parenting anxiety and depressionVariation between initial assessment and post-intervention and between initial assessment and 6 months post-interventionAssessment with the Hospital Anxiety and Depression Scale (HADS)
Adolescent depressionVariation between initial assessment and post-intervention and between initial assessment and 6 months post-interventionAssessment with the Child Depression Inventory (CDI)
Suicidal ideationVariation between initial assessment and post-intervention and between initial assessment and 6 months post-interventionAssessment with the C-SSRS

Contacts

Primary ContactJulie CABROL
cares@chu-montpellier.fr0467337196
Backup ContactAllison GOUJON
cares@chu-montpellier.fr0467337195

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026