Understanding and Acting to Regulate Suicidal Behavior

NCT06689657 | Not Yet Recruiting DMC

• 1 other identifier: RECHMPL22_0339 / UF 8379
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Occurence of suicidal behavior

  Assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)

  Variation between initial assessment and assessment 6 month post intervention

Secondary Outcomes (5)

• Clinical improvement assessement (clinician)

  Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention

• Parenting stress

  Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention

• Parenting anxiety and depression

  Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention

• Adolescent depression

  Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention

• Suicidal ideation

  Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention

Study Arms (2)

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

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

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

Interventions

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 groupe therapy (CARES) only

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

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

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

MeSH Terms

Conditions

Suicidal Ideation; Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Julie CABROL

CONTACT

0467337196; cares@chu-montpellier.fr

Allison GOUJON

CONTACT

0467337195; cares@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 14, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): January 6, 2028
• Study Completion (Estimated): July 6, 2028
• Last Updated: November 14, 2024

Record last verified: 2024-11