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. 2015 Dec 21;2015(12):CD012013. doi: 10.1002/14651858.CD012013

Rossouw 2012a.

Study characteristics
Methods Allocation: randomisation using a minimisation procedure controlling for: i) age; ii) gender; iii) number of prior hospital admissions for SH.
Follow‐up period: 3, 6, 9, and 12 months.
N lost to follow up: 9/80 (11.2%) for SH at the 12 month follow‐up.
Participants Inclusion criteria: i) 12‐17 years; ii) presented with at least one episode of SH within the past month; iii) episode of SH was primary reason for referral to psychiatric services.
Exclusion criteria: i) required inpatient psychiatric treatment; ii) diagnosed with comorbid psychosis, a severe learning disability, a pervasive developmental disorder, or an eating disorder in the absence of SH; iii) diagnosed with any chemical dependence.
Numbers: Of the 80 participants, 40 were allocated to the intervention arm and 40 to the control arm.
Profile: 85.0% (n = 68) were female; 96.2% (n = 77) were diagnosed with depression; 72.5% (n = 58) were diagnosed with borderline personality disorder.
Source of participants: patients presenting to community health services or acute hospital emergency rooms following an episode of SH.
Location: London, UK.
Interventions Experimental: mentalisation‐based treatment adapted for adolescents involving manualised psychodynamic psychotherapy sessions for both the adolescent and his/her family.
Control: treatment as usual according to current NICE guidelines (NICE 2004). "The majority of...participants in the TAU group received the following: an individual therapeutic session alone (28%), consisting of counselling (in 38% of cases receiving an individual intervention), generic supportive interventions (24%), cognitive behavioral therapy (19%), or psychodynamic psychotherapy (19%); a combination of individual therapy and family work (25%); or psychiatric review alone (27.5%)" (p.1306).
Therapist: 22 therapists from a variety of different professional backgrounds who received 6 days training in delivering mentalisation‐based treatment.
Type of therapy offered: mentalisation.
Length of treatment: 12 months.
Outcomes Included: i) repetition of SH according to scores on SH scale of the Risk‐Taking and Self‐Harm Inventory; ii) depression; iii) hopelessness; iv) compliance.
Excluded: i) borderline personality disorder symptom severity; ii) feelings.
Notes Source of funding: no details on funding are provided.
Declaration of author interests: "Dr. Fonagy is the Chief Executive of the Anna Freud Centre, London, which regularly offers training courses in mentalization based treatment...and National Clinical Lead for the Department of Health's Improved Access to Psychological Therapies (IAPT) for Children and Young People Programme. He has received grant income from the National Institute of Clinical Excellence, the UK Mental Health Research Network, the British Academy, the Wellcome Trust, the National Institute of Health Research (Senior Investigator Award and Research for Patient Benefit Programme), the Pulitzer Foundation, the Department for Children, Schools, and Families, the Central and East London Comprehensive Local Research Network (CLRN) Programme, the NHS Health Technology Assessment (HTA) programme, the Department of Health's IAPT Programme, and the Hope for Depression Foundation. Dr. Rossouw reports no biomedical, financial interests, or potential conflicts of interest" (p.1312).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Allocation was by minimization, controlling for past hospital admissions, gender, and age." (p.1305).
Comment: Use of a minimisation procedure is likely to have minimised the role of bias in the generation of the randomisation sequence.
Allocation concealment (selection bias) Low risk Quote: "...participants were randomized by an independent statistician working off‐site..." (p.1306).
Blinding (performance bias and detection bias)
Of participants Low risk Quote: "...participants were...blinded to assignment" (p.1305).
Blinding (performance bias and detection bias)
Of personnel High risk Comment: The nature of the study means personnel are likely to have known which participant was receiving which treatment.
Blinding (performance bias and detection bias)
Of outcome assessors Low risk Quote: "assessors...were...blinded to assignment" (p.1305).
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "Data analysis was by intention to treat" (p.1306).
Selective reporting (reporting bias) Unclear risk Comment: No reason to suspect that all outcomes were not measured, however, in the absence of the trial protocol, this cannot be ascertained.
Other bias Low risk Comment: No apparent other sources of bias.