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

ISRCTN ISRCTN97589104
DOI https://doi.org/10.1186/ISRCTN97589104
Secondary identifying numbers N/A
Submission date
23/08/2007
Registration date
23/08/2007
Last edited
31/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H.M. Schuppert
Scientific

University Medical Centre Groningen (UMCG)
Department of Psychiatry
P.O. Box 30001
Groningen
9700 AR
Netherlands

Email m.schuppert@accare.nl

Study information

Study designMulticentre, randomised, single-blind, active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEvaluation of a group training for adolescents (Emotion Regulation Training) with emotion regulation problems - a randomised controlled clinical trial
Study acronymERT - evaluation
Study objectivesHas the Emotion Regulation Training (ERT) for adolescents a surplus value compared to treatment as usual?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBorderline personality disorder in adolescents
InterventionERT 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 typeOther
Primary outcome measurePrimary 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 measuresSecondary 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 study start date01/08/2007
Completion date01/10/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit14 Years
Upper age limit18 Years
SexNot Specified
Target number of participants128
Total final enrolment109
Key inclusion criteria1. 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
Key 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 (Intelligence Quotient [IQ] less than 80)
Date of first enrolment01/08/2007
Date of final enrolment01/10/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre Groningen (UMCG)
Groningen
9700 AR
Netherlands

Sponsor information

Accare (The Netherlands)
Research organisation

Division University Centre for Child and Adolescent Psychiatry
P.O. Box 660
Groningen
9700 AR
Netherlands

Phone +31 (0)50 361 0973
Email info@accare.nl
Website http://www.accare.nl/
ROR logo "ROR" https://ror.org/02h4pw461

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2012 31/12/2020 Yes No

Editorial Notes

31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.