Condition category
Mental and Behavioural Disorders
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
23/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.accare.nl/

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

Publication citations

Additional files

Editorial Notes