Emotion Regulation Group Study

Study Overview
=================
Brief Summary
-----------------
A clinical trial to evaluate the effects of an eight-week emotion regulation group intervention designed for adolescents (16-20 years old) on the levels of emotion dysregulation both self-reported by the adolescent and reported by his/her parent/caregiver (pre-post comparison). The long-term effect will also be measured at a third-time point, three months after the end of the intervention. The intervention will consist of 90-minute sessions once a week for 8 weeks, in groups of eight participants. The intervention proposed for this study is an adaptation from different interventions already in use for adolescents in clinical practice, such as Dialectical Behavior Therapy (DBT), Mentalization-Based Treatment (MBT) and Mindfulness-Based Intervention (MBI).

Official Title
-----------------
Emotion Regulation Group Intervention for Late Adolescents: a Clinical Trial

Conditions
-----------------
Emotional Dysfunction, Borderline Personality Disorder

Intervention / Treatment
-----------------
* Behavioral: Emotion regulation group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 16 to 20 years old. > 4 criteria of borderline symptoms (out of the 9 listed in the DSM-5) including emotional liability French speaking Availability during the whole study Willingness in participating to the intervention and the research Informed consent read and signed Exclusion Criteria: Current hospitalization Psychotic disorder Severe and persistent substance addiction Antisocial personality disorder Inability to participate in group sessions Current pregnancy Non-French speaking Previous enrolment into the current study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: psychotherapeutic intervention with class risk A (low risk, no invasive procedure)<br>an eight-week emotion regulation group intervention | Behavioral: Emotion regulation group<br>* 90 minute sessions once a week for 8 weeks, in groups of eight participants. DBT, MBT and MBI inspired, psychoeducative intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline in Difficulties in emotion regulation scale (DERS) | 36 items self-report scale: Higher scores suggest greater problems with emotion regulation. | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in Difficulties in emotion regulation scale (DERS) | 36 items self-report scale: Higher scores suggest greater problems with emotion regulation. | V3 (3 months after the intervention) | 
| Changes from Baseline in Emotion Dysregulation Inventory (EDI) | Informant-report measure of emotion dysregulation | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in Emotion Dysregulation Inventory (EDI) | Informant-report measure of emotion dysregulation | V3 (3 months after the intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline in Beck Depression Inventory (BDI-II) | Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms) | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in Beck Depression Inventory (BDI-II) | Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms) | V3 (3 months after the intervention) | 
| Changes from Baseline in State-Trait Anxiety Inventory (STAI) | 40 self-report items on a 4-point Likert scale: higher scores = greater anxiety | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in State-Trait Anxiety Inventory (STAI) | 40 self-report items on a 4-point Likert scale: higher scores = greater anxiety | V3 (3 months after the intervention) | 
| Changes from Baseline in self-report Family Attitude Scale (FAS) | 30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment) | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in self-report Family Attitude Scale (FAS) | 30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment) | V3 (3 months after the intervention) | 
| Changes from Baseline in parent-report Family Attitude Scale (FAS) | 30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment) | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in parent-report Family Attitude Scale (FAS) | 30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment) | V3 (3 months after the intervention) | 
| Changes from Baseline in Borderline Symptom List (BSL-23) | Self-rating tool for Borderline Personality Disorder (BPD) symptoms: higher scores = more likely to have BPD and associated challenges | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in Borderline Symptom List (BSL-23) | Self-rating tool for BPD symptoms: higher scores = more likely to have BPD and associated challenges | V3 (3 months after the intervention) | 
| Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ) | brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative. | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ) | brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative. | V3 (3 months after the intervention) | 
| Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ) | brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative. | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ) | brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative. | V3 (3 months after the intervention) | 
| Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ) | Self-report measure designed to assess individual differences in cognitive regulation of emotions in response to stressful events. subscale scores can range from 4 to 20 with higher subscale scores indicating greater frequency of use of the specific cognitive strategy. | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ) | Self-report measure designed to assess individual differences in cognitive regulation of emotions in response to stressful events. subscale scores can range from 4 to 20 with higher subscale scores indicating greater frequency of use of the specific cognitive strategy. | V3 (3 months after the intervention) | 
| Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS) | self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS) | self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness | V3 (3 months after the intervention) | 
| Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS) | Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale. | V2 (within two weeks after the end of the intervention) | 
| Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS) | Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale. | V3 (3 months after the intervention) |