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Evaluation of a grouptraining for adolescents (Emotion Regulation Training) with emotion regulation problems - a randomised controlled clinical trial.


- candidate number2603
- NTR NumberNTR984
- ISRCTNISRCTN97589104
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR25-mei-2007
- Secondary IDs 
- Public TitleEvaluation of a grouptraining for adolescents (Emotion Regulation Training) with emotion regulation problems - a randomised controlled clinical trial.
- Scientific TitleEvaluation of a grouptraining for adolescents (Emotion Regulation Training) with emotion regulation problems - a randomised controlled clinical trial using the BPDSI-IV-ado and the LPI as primary outcome measures.
- ACRONYMERT - evaluation
- hypothesisHas the Emotion Regulation Training for adolescents a surplus value compared to treatment as usual?
- Healt Condition(s) or Problem(s) studiedBorderline personality disorder , Adolescents, Emotion regulation training
- Inclusion criteria1. Age 14-18 years; 2. Affective instability due to a marked reactivity of mood (e.g., intense episodic dysphoria, irritability, or anxiety usually lasting a few hours and only rarely more than a few days; 3. At least two other DSM-IV criteria of BPD; 4. Minimum score of 15 on the Borderline Personality Disorder Severity Index - adolescent version.
- Exclusion criteria1. Psychotic disorders (except short, reactive psychotic episodes); 2. Conduct disorder; 3. Addiction of such severity that clinical detoxification is indicated; 4. Mental retardation (IQ less than 80).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-aug-2007
- planned closingdate1-okt-2010
- Target number of participants128
- InterventionsERT consists of 17 weekly group sessions (6-9 participants, 1,75 hours), one psycho-educational session with parents/caretakers and/or partners and two booster sessions, at three and six months after the weekly course. The first aim is to learn how to deal with daily stress and psychological vulnerability. Reducing self-harm or harm to others is an important issue. After the training there will be a session with the adolescent, his or her parents or caretakers, the therapists of the training and the individual therapist, to offer good continuation in the regular treatment.
- Primary outcomePrimary outcome measures at baseline, directly after the training and at 6 months follow-up: 1. Severity of Borderline Personality symptoms (BPDSI-IV-adolescents, semi-structured interview) measuring the current severity and frequency of the DSM-IV BPD manifestations; 2. Life Problems Inventory (LPI, questionnaire), measuring the main symptoms of BPD.
- Secondary outcomeSecondary outcome measures at baseline, directly after the training and at 6 months follow-up: 1. DSM diagnosis axis II (PDQ-4, parts of k-SADS and SCID-II); 2. mental health disorders (CDI, RAPI, SCL-90, SDQ); 3. Locus of Control (MALC-ERT); 4. Quality of Life (YQOL); 5. Raising style, parental stress and parental functioning (EMBU, PSI and GHQ); 6. Consumption of public health services; 7. global functioning (CGAS or GAF score).
- Timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. MD. H.M. Schuppert
- CONTACT for SCIENTIFIC QUERIESDrs. MD. H.M. Schuppert
- Sponsor/Initiator Accare, Division University Center for Child and Adolescent Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications-
- Brief summaryEmotional dysregulation is the main symptom of borderline personality disorder (BPD). BPD is an invalidating disorder with much impact on the patient's functioning. Self-injury and suicide attempts frequently occur. These patients pose an enormous demand on public health care, with frequent interventions and many crises. BPD is rarely diagnosed before the age of 18. Nevertheless, symptoms of BPD are often seen at a younger age and lead to significant distress in the adolescent and his or her family. Treatment at an early stage may prevent the development of a full-blown personality disorder in adulthood as well as the negative consequences related to BPD. Although there are different ways of treating adults with BPD, no effective treatment program for adolescents is available in the Netherlands. At the outpatient clinic of Accare we developed a course for adolescents that was based on a course for adults (STEPPS, developed by Bartels, Crottie and Blum). Adolescents learn to handle emotional dysregulation. A pilot study has currently been conducted. Thus, the practical feasibility of the course is already tested and the measures are explored. Getting control over your emotions and thoughts and taking responsibility for your own behaviour are the main goals of the Emotion Regulation Training. In the pilot study, the ERT gave a significant improvement in patientís feelings of having control over their emotions, shown by an increase on a scale measuring the locus of control. The goal of the study is to evaluate the effectiveness of the course, to obtain information on follow-up, and to give an impuls for implementation of the course in the participating centres for mental health care. The design is a randomised controlled clinical trial. 128 Adolescents in at least five settings for mental health care will be included and randomised into two conditions, namely 1. 17-week course + standardised (embedded) treatment as usual or 2. treatment as usual only. Assessments take place before and after the course and at one-year follow-up. Adolescents aged 14-18 years, who were referred to mental health care centres in the North of the Netherlands, suffering from emotional dysregulation, and their parents or caretakers, will be asked to participate in the study. ERT consists of 17 weekly group sessions (6-9 participants, 1,75 hours), one psycho-educational session with parents/caretakers and/or partners and two booster sessions, at three and six months after the weekly course. The first aim is to learn how to deal with daily stress and psychological vulnerability. Reducing self-harm or harm to others is an important issue. After the training there will be a session with the adolescent, his or her parents or caretakers, the therapists of the training and the individual therapist, to offer good continuation in the regular treatment.
- Main changes (audit trail)
- RECORD25-mei-2007 - 27-aug-2007


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