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
Scientific
University Medical Centre Groningen (UMCG)
Department of Psychiatry
P.O. Box 30001
Groningen
9700 AR
Netherlands
m.schuppert@accare.nl |
Study information
Study design | Multicentre, randomised, single-blind, active controlled parallel group trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 01/08/2007 |
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 number of participants | 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
9700 AR
Netherlands
Sponsor information
Accare (The Netherlands)
Research organisation
Research organisation
Division University Centre for Child and Adolescent Psychiatry
P.O. Box 660
Groningen
9700 AR
Netherlands
Phone | +31 (0)50 361 0973 |
---|---|
info@accare.nl | |
Website | http://www.accare.nl/ |
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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.