Understanding and Acting to Regulate Suicidal Behavior
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-16
SponsorUniversity Hospital, Montpellier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive behavioral group therapy for adolescents and non violent resistance group for parents
BehavioralIn 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 interventionIn 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
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Adolescent group therapy (CARES) and parent group therapy (RNV)Other 1 intervention
Group B: Adolescent groupe therapy (CARES) onlyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurence of suicidal behavior
Assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame
Variation between initial assessment and assessment 6 month post interventionSecondary outcomes
1
Clinical improvement assessement (clinician)
Assessment with the Clinical Global Impression-Improvement (CGI-I)
Time frame
Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention2
Parenting stress
Assessment with the Parenting Stress Index short form (PSI-4-SF)
Time frame
Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention3
Parenting anxiety and depression
Assessment with the Hospital Anxiety and Depression Scale (HADS)
Time frame
Variation between initial assessment and post-intervention and between initial assessment and 6 months post-intervention4
Adolescent depression
Assessment with the Child Depression Inventory (CDI)
Time frame
Variation between initial assessment and post-intervention and between initial assessment and 6 months post-interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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