Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Trudie Rossouw


Contact details

107a Barley Lane
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

The proposed sample group will be adolescents who harm themselves either through cutting or self poisoning and our hypotheses, which we aim to test in this study, is that the sample group will have a higher incidence of deficit in their capacity to mentalise (the ability to observe and understand invisible mental states of the self and the others, such as intentions, thoughts, desires, expectations, memories). Our hypothesis further is that the self harm group is likely to have a higher incidence of personality dysfunction, in particular of the borderline kind.

Secondly, we aim to compare Mentalisation Based Treatment (MBT) for the clinical sample group against Treatment As Usual (TAU) to test whether MBT will lead to a reduction in self harm behaviour; a reduction in sense of hopelessness and improved interpersonal relationships in comparison to TAU.

Lastly we hope to examine the mentalisation capacity and personality profiles in the parents of the clinical and the non-clinical groups, with the hypothesis being that the clinical group will present with a higher incidence of mentalisation deficit in the parents. We also hope to measure whether mentalisation based family therapy (Short Term Mentalisation and Relational Therapy [SMART]) improves the mentalisation capacity in the parents and in family functioning.

Ethics approval

Ethics approval received from the Redbridge and Waltham Forest Ethics Committee in February 2006.

Study design

Blinded randomised controlled trial with two treatment groups: mentalisation based treatment versus treatment as usual. Pretest-post test design.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Self harm/borderline personality traits


Two treatments: mentalisation based treatment measured against treatment as usual.

MBT Treatment programme:
The treatment will take three forms:
1. Individual once weekly psychotherapy sessions using the MBT approach
2. Family therapy using the SMART technique, fortnightly moving to once monthly after 4 sessions
3. Group therapy fortnightly beginning 6 months into treatment when sufficient participants have been recruited to comprise the groups

Treatment is planned to continue for an 18-month period. At the end of this period, further treatment/monitoring shall be offered to those individuals who still display severe psychopathology and/or risk to themselves or others where it is judged by the clinicians involved that further support may be beneficial. If this applies to a number of individuals this continued treatment may take to form of a group.

Qualified professionals in mental health who have additional training in MBT and in SMART treatment will provide treatment. The clinicians in the study will receive weekly supervision on their clinical work. Some of the individual and family sessions will be randomly selected to be recorded or observed in order that they can be independently rated. This will ensure that the therapy is consistent with the model and that the measure of the therapies’ effect is valid.

Risk will be managed by a detailed risk assessment at the outset of the study, as well as an ongoing monitoring of risk by the clinicians. Dr T Rossouw will provide psychiatric input. Emergencies after hours will be managed via the routine emergency procedures in North East London Mental Health Trust (NELMHT), which is that the young people are seen in Accident and Emergency (A & E) where they are medically examined and managed by the A & E staff and then seen for a mental state examination and risk assessment by the on call psychiatrist, who will liaise telephonically with Dr Rossouw.

Treatment as Usual:
This treatment will be provided by the tier 3 clinicians as they routinely do. Tier 3 clinicians are trained professionals working in child and adolescent psychiatry. For this group we shall be recording the number of times they were seen, the professions of the clinicians they saw and the clinician’s definition of the sessions’ format and purpose, i.e. assessment or intervention, type of assessment and type of intervention.

Intervention type



Not Specified

Drug names

Primary outcome measure

The assessment battery will consist of the following assessments for the identified adolescent:
1. Mood and Feelings Questionnaire
2. Millon Adolescent Clinical Inventory (MACI)
3. Childhood Inventory of Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) Borderline Personality Disorder (CI-BPD)
4. The Reading the Mind in the Eyes Test
5. Trust game and questionnaire
7. Intelligence Quotient (IQ)
8. Self Harming Inventory

Every 3 months the self harm inventory and the mood and feelings questionnaire will be re-adminstered.

Outcome/Post-treatment measures:
1. Mood and Feelings Questionnaire
2. Millon Adolescent Clinical Inventory (MACI)
3. Childhood Inventory of DSM-IV Borderline Personality Disorder (CI-BPD)
4. The Reading the Mind in the Eyes Test
5. Social Functioning
6. Self-harming Inventory

Secondary outcome measures

In addition the following assessments will be given to the adolescents’ parent or guardian:
1. Millon Clinical Multiaxial Inventory-III (MCMI-III)
2. Family assessment tool (Systemic Inventory of Change [STIC])
3. The Reading the mind in the Eyes Test

At the end of the study the following measures will be given to the parents. In addition the following assessments will be given to the adolescents’ parent or guardian:
2. Family assessment tool
3. The Reading the mind in the Eyes Test

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Young people between the ages of 13 - 18 years with a history of self harm
2. Self harm will be defined as any act performed with the intention to harm themselves, e.g. cutting, burning, overdose
3. Eating disorders will only be included if accompanied by another form of self harm as well

Participant type


Age group




Target number of participants

60 for the RCT

Participant exclusion criteria

1. Learning disability
2. Autism and Asperger's
3. Psychosis

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

United Kingdom

Sponsor information


North East London Mental Health Trust (NELMHT) (UK)

Sponsor details

c/o Dr Alex Horne
Goodmayes Hospital
Barley Lane
United Kingdom

Sponsor type




Funder type


Funder name

North East London Mental Health Trust (NELMHT) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2012 results in

Publication citations

  1. Results

    Rossouw TI, Fonagy P, Mentalization-based treatment for self-harm in adolescents: a randomized controlled trial., J Am Acad Child Adolesc Psychiatry, 2012, 51, 12, 1304-1313.e3, doi: 10.1016/j.jaac.2012.09.018.

Additional files

Editorial Notes