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
Protocol serial number	N/A
Sponsor	Accare (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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

Primary study design	Interventional
Study design	Multicentre, randomised, single-blind, active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Evaluation of a group training for adolescents (Emotion Regulation Training) with emotion regulation problems - a randomised controlled clinical trial
Study acronym	ERT - evaluation
Study objectives	Has 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) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	14 Years
Upper age limit	18 Years
Sex	Not Specified
Target sample size at registration	128
Total final enrolment	109
Key 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
Key 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)
Date of first enrolment	01/08/2007
Date of final enrolment	01/10/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre Groningen (UMCG)

Groningen
9700 AR
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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.