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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR984 |
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Date of registration:
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25/05/2007 |
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Primary sponsor: |
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Public title:
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Evaluation of a grouptraining for adolescents (Emotion Regulation Training) with emotion regulation problems - a randomised controlled clinical trial.
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Scientific title:
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Evaluation 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. - ERT - evaluation |
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Date of first enrolment:
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1/8/2007 |
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Target sample size:
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128 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=984 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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H.M.
Schuppert |
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Address:
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University Medical Center Groningen (UMCG), Department of Psychiatry,
P.O. Box 30001, Hanzeplein 1
9700 AR
Groningen
The Netherlands |
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Telephone:
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Email:
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m.schuppert@accare.nl |
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Affiliation:
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Name:
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H.M.
Schuppert |
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Address:
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University Medical Center Groningen (UMCG), Department of Psychiatry,
P.O. Box 30001, Hanzeplein 1
9700 AR
Groningen
The Netherlands |
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Telephone:
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Email:
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m.schuppert@accare.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 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 criteria: 1. 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).
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Borderline personality disorder , Adolescents, Emotion regulation training
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Intervention(s)
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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.
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Primary Outcome(s)
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Primary 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.
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Secondary Outcome(s)
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Secondary 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).
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Secondary ID(s)
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ISRCTN97589104
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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