Contact information
Type
Scientific
Primary contact
Dr H.M. Schuppert
ORCID ID
Contact details
University Medical Centre Groningen (UMCG)
Department of Psychiatry
P.O. Box 30001
Groningen
9700 AR
Netherlands
m.schuppert@accare.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ERT - evaluation
Study hypothesis
Has the Emotion Regulation Training (ERT) for adolescents a surplus value compared to treatment as usual?
Ethics approval
Not provided at time of registration
Study design
Multicentre, randomised, single-blind, active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Borderline personality disorder in adolescents
Intervention
ERT consists of 17 weekly group sessions (6 to 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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Primary outcome measures at baseline, directly after the training and at six months follow-up:
1. Severity of Borderline Personality symptoms (Borderline Personality Disorder Severity Index for adolescents, fourth version [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 outcome measures
Secondary outcome measures at baseline, directly after the training and at six months follow-up:
1. DSM diagnosis axis II (Personality Diagnostic Questionnaire [PDQ-4], parts of kiddie-Schedule for Affective Disorders and Schizophrenia [k-SADS] and Structured Clinical Interview for DSM-IV [SCID-II])
2. Mental health disorders (Child Depression Inventory [CDI], Rutgers Alcohol Problems Index [RAPI], Symptom Check List [SCL-90], Strengths and Difficulties Questionnaire [SDQ])
3. Locus of Control (Multidimensional Anxiety Locus of Control scale [MALC-ERT])
4. Quality of Life (Youth 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)
Overall trial start date
01/08/2007
Overall trial end date
01/10/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 14 to 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 Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria of Borderline Personality Disorder (BPD)
4. Minimum score of 15 on the Borderline Personality Disorder Severity Index - adolescent version
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
128
Participant 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 (Intelligence Quotient [IQ] less than 80)
Recruitment start date
01/08/2007
Recruitment end date
01/10/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Groningen (UMCG)
Groningen
9700 AR
Netherlands
Sponsor information
Organisation
Accare (The Netherlands)
Sponsor details
Division University Centre for Child and Adolescent Psychiatry
P.O. Box 660
Groningen
9700 AR
Netherlands
+31 (0)50 361 0973
info@accare.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary