|- candidate number||1558|
|- NTR Number||NTR356|
|- Date ISRCTN created||19-dec-2005|
|- date ISRCTN requested||28-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||1558 |
|- Public Title||Evaluation of a group training for adolescents (Emotion Regulation Training) with emotion regulation problems.|
|- Scientific Title||Randomised controlled clinical trial of a group training for adolescents with emotion regulation problems.|
|- ACRONYM||Borderline Personality Disorder, Adolescents, Therapy, Randomised Controlled Trial|
|- hypothesis||Adolescents with emotion regulation problems who followed the Emotion Regulation Training will show improvement on the following items: |
1. Symptoms of emotional dysregulation;
2. Positive and negative coping behaviour;
3. Stress symptoms in the adolescent;
4. Stress symptoms in the parents (or care-takers);
5. Consumption of public health services
compared to a waitlist control group.
|- Healt Condition(s) or Problem(s) studied||Mental illness, Borderline personality disorder |
|- Inclusion criteria||1. Age 14-18 years;|
2. Emotion regulation problems;
3. Some self-awareness;
4. Sufficient internal motivation;
5. Willing to share his or her experiences in a group;
6. Environment is rather stable;
7. Capable to join a group-session without agressive behaviour;
8. No substance abuse and self-mutilating behaviour during the session.
|- Exclusion criteria||If the adolescent does not meet the inclusion criteria.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2005|
|- planned closingdate||1-sep-2006|
|- Target number of participants||48|
|- Interventions||The Emotion Regulation Training (ERT) is a skills-training (17 weekly sessions of 1,75 hours as weel as one session for significant others) based on psycho-education, cognitive behavioural principles, and excercises for relaxation.|
Care as usual generally includes individual sessions with the adolescent and medication checks, sometimes combined with family sessions, crisis intervention or parent training.
|- Primary outcome||1. Borderline Personality Disorder Severity Index (BPDSI and BPDSI - parent version): |
a semi-structured interview based on the DSM-IV classification of psychopathology. Trained psychologists will conduct this semi-structured interview;
2. VERS-scale: to measure negative as well as positive behaviour in a certain period. This questionnaire is to be completed by the adolescent as well as the parents.
|- Secondary outcome||Questionnaires completed by the adolescents as well as the parents:|
1. Frequency list of Emotion Regulation Problems (F-ERP);
2. Global Assessment of Functioning (GAF): present level of funcioning (axis V of DSM-IV);
3. MALC-ERT: list of 18 items to draw up an inventory of cognitions on emotional dysregulation (locus of control);
4. Child Behaviour Checlist (CBCL): consists of 118 items describing a wide domain of behaviour problems of children.
Questionnaire only to be completed bij parents:
Nijmeegse Ouderlijke Stress Index (NOSI; Parental Stress Index): to measure stress in parents (124 items).
Questionnaire only to be completed by the adolescent:
Healthcare consumption: a short list to be completed weekly during the training, about different types of healthcare being used in the last week (e.a.: primay healthcare, emergency rooms, crisis contact psychiatry department.
|- Trial web site||http://www.accare.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. MD. H.M. Schuppert|
|- CONTACT for SCIENTIFIC QUERIES||Drs. MD. H.M. Schuppert|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Accare, Division University Center for Child and Adolescent Psychiatry|
(Source(s) of Monetary or Material Support)
|- Publications||Clin Psychol Psychother. 2009 Nov;16(6):467-78.|
|- Brief summary||Emotional 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 (developed by Bartels, Crottie and Blum). Adolescents learn to handle emotional dysregulation.
This study is a pilot study in the North of the Netherlands.
48 Adolescents will be included and randomised into two conditions, namely: 1. 17-week course + care as usual or 2. waitlist with care as usual. Assessments take place before and after the course and at a half year follow-up.
|- Main changes (audit trail)|
|- RECORD||12-sep-2005 - 27-okt-2010|