Suicidal IdeationCARESNCT06689657
Understanding and Acting to Regulate Suicidal Behavior
A study testing Cognitive behavioral group therapy for adolescents and non violent resistance group for parents and Adolescent group therapy (CARES) and parent group therapy (RNV) in people with Suicidal Ideation and Suicidal Behavior, run by University Hospital, Montpellier.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Suicidal Ideation, Suicidal Behavior, Self-harm Behavior
- What is being tested?
- Cognitive behavioral group therapy for adolescents and non violent resistance group for parents and Adolescent group therapy (CARES) and parent group therapy (RNV)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2025to 6 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Study of Two Modalities of Cognitive-behavioral Group Therapy in Adolescents with Suicidal Ideation or Suicidal Behavior
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.
Read the 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
- Being tested
- Cognitive behavioral group therapy for adolescents and non violent resistance group for parents, Adolescent group therapy (CARES) and parent group therapy (RNV)
- Keywords
- Suicide prevention, Cognitive-behavioral therapy, Dialectical Behavior Therapy, Non pharmacological intervention, Adolescent
- Medical subject headings
- Suicidal Ideation, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral group therapy for adolescents and non violent resistance group for parentsBehavioural
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
Adolescent group therapy (CARES) and parent group therapy (RNV)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
| Study group | Role | What they receive |
|---|---|---|
| Adolescent group therapy (CARES) and parent group therapy (RNV) | 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 Receives: Other: Adolescent group therapy (CARES) and parent group therapy (RNV) |
| Adolescent groupe therapy (CARES) only | Experimental | 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 Receives: Behavioral: Cognitive behavioral group therapy for adolescents and non violent resistance group for parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of suicidal behavior
Assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Variation between initial assessment and assessment 6 month post intervention
Secondary outcomes (5)
Clinical improvement assessement (clinician)
Assessment with the Clinical Global Impression-Improvement (CGI-I)
Measured: Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention
Parenting stress
Assessment with the Parenting Stress Index short form (PSI-4-SF)
Measured: Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention
Parenting anxiety and depression
Assessment with the Hospital Anxiety and Depression Scale (HADS)
Measured: Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention
Adolescent depression
Assessment with the Child Depression Inventory (CDI)
Measured: Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention
Suicidal ideation
Assessment with the C-SSRS
Measured: Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start6 Jan 2025 (estimated)
- Primary completion6 Jan 2028 (estimated)
- Study completion6 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adolescent group therapy (CARES) and parent group therapy (RNV) vs Adolescent groupe therapy (CARES) only
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689657
- Sponsor's protocol ID
- RECHMPL22_0339 / UF 8379
- Acronym
- CARES
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Two Modalities of Cognitive-behavioral Group Therapy in Adolescents with Suicidal Ideation or Suicidal Behavior
- ClinicalTrials.gov ID
- NCT06689657
- Acronym / sponsor ID
- CARES / RECHMPL22_0339 / UF 8379
- Conditions
- Suicidal Ideation, Suicidal Behavior, Self-harm Behavior, Adolescents
- Keywords
- Suicide prevention, Cognitive-behavioral therapy, Dialectical Behavior Therapy, Non pharmacological intervention, Adolescent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 6 Jan 2025 (estimated)
- Primary completion
- 6 Jan 2028 (estimated)
- Study completion
- 6 Jul 2028 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Adolescent group therapy (CARES) and parent group therapy (RNV) vs Adolescent groupe therapy (CARES) only
| Arm | Type | Receives |
|---|---|---|
| Adolescent group therapy (CARES) and parent group therapy (RNV) | Other | Other: 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 |
| Adolescent groupe therapy (CARES) only | Experimental | Behavioral: Cognitive behavioral group therapy for adolescents and non violent resistance group for parentsIn 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 |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral group therapy for adolescents and non violent resistance group for parentsIn 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 | Behavioural | Adolescent groupe therapy (CARES) only |
| 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 | Other | Adolescent group therapy (CARES) and parent group therapy (RNV) |
Primary outcome
Occurence of suicidal behavior
Time frame: Variation between initial assessment and assessment 6 month post intervention
Assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
5 secondary outcomes
Clinical improvement assessement (clinician)
Time frame: Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention
Parenting stress
Time frame: Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention
Parenting anxiety and depression
Time frame: Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention
Adolescent depression
Time frame: Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention
Suicidal ideation
Time frame: Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral group therapy for adolescents and non violent resistance group for parents and Adolescent group therapy (CARES) and parent group therapy (RNV) in people with Suicidal Ideation and Suicidal Behavior, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie CABROL (0467337196 ext. +33, cares@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of suicidal behavior (time frame: Variation between initial assessment and assessment 6 month post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.