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NCT Number: NCT06689657

Understanding and Acting to Regulate 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.

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Key information

Conditions

Suicidal Ideation Adolescents Behavior Behavioral Symptoms Self-Injurious Behavior Self-harm Behavior Suicidal Behavior Suicide Suicide Prevention

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Allison GOUJON

CONTACT

[email protected]

0467337195 ext. +33

Julie CABROL

CONTACT

[email protected]

0467337196 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: CARES

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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