Understanding and Acting to Regulate Suicidal Behavior (CARES)

November 13, 2024 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

108

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 Contact

Study Contact Backup

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

Accepts Healthy Volunteers

No

Description

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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Experimental: 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
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Variation between initial assessment and assessment 6 month post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement assessement (clinician)
Time Frame: 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)
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
Assessment with the Parenting Stress Index short form (PSI-4-SF)
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
Assessment with the Hospital Anxiety and Depression Scale (HADS)
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
Assessment with the Child Depression Inventory (CDI)
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
Assessment with the C-SSRS
Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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)

January 6, 2025

Primary Completion (Estimated)

January 6, 2028

Study Completion (Estimated)

July 6, 2028

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL22_0339 / UF 8379

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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