Treatment for Adolescents With Deliberate Self Harm
Condition: Intentional Self Harm
MeSH terms: Self Mutilation; Self-Injurious Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficiency of dialectical behavior therapy (DBT)
      in treatment of adolescents with deliberate self harm compared to Enhanced Usual Care (EUC).
      Eighty patients in the age of 12-18 yrs old will be included in the study. The main inclusion
      criterion is repetitive deliberate self-harm. The patients will receive 16 weeks treatment in
      outpatient clinics in Oslo, after having been randomized to DBT or EUC. They will be assessed
      on five different time-points: baseline (before starting treatment), 6 weeks (after start of
      treatment), 12 weeks, 16 weeks and 68 weeks.

      The main study hypothesis is:

        -  DBT will be significantly more effective in treatment of self-harm behavior, as
           measured/indicated by reduction in number of self-harm episodes with or without intent
           to die, as well as reduction of number of emergency room visits.

        -  It is also hypothesized that DBT will significantly reduce the level of suicidal
           ideation and depressive symptoms compared to EUC.
    

Detailed description: 
      Power analysis:

      Exact data on the repetition of self-harm over 16-20 week and 12 months observation periods
      for adolescents in outpatient psychiatric treatment are not available. Building on previous
      clinical studies and RCT studies in adults receiving DBT, we anticipate that the 16 week
      repetition rate will be 50% for adolescents who receive EUC and 25% for adolescents who
      receive DBT. With an alpha error level of 5% 60 patients in each group is needed to provide
      80% power with a two tailed test. We anticipate a drop out rate from research assessments of
      no more than 25%. To compensate for this attrition, it is calculated that 15 patients in each
      treatment group should be added, leading to a total number of 150 patients to be included in
      the trial. A more precise power analysis and determination of how many patients to include in
      the study will be based on data from the first 40 patients who have been included.

      A power analysis conducted on the basis of the first 40 patients showed that:

        1. There had been no attrition from research assessments

        2. With an alpha error level of 5% 40 patients in each group is needed to provide 80% power
           with a two tailed test

      A final number of patients to include was therefore fixed at 80.
    

Intervention name(s): Dialectical behavioral therapy for adolescents (DBT-A); Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients randomised to DBT-A will receive 16 weeks treatment, with one weekly session (60 minutes)of individual therapy, one weekly session of multifamily skills training (120 minutes), and telephone coaching outside therapy sessions.
The treatment has been developed by Marsha Linehan (Linehan, 1993a; 1993b)and adapted for adolescents by Alec Miller (Miller, Rathus & Linehan, 2007). Individual DBT therapists have been trained by drs Alec L Miller and Sarah K Reynolds and have a minimum of one year clinical practise as DBT therapists. The therapists are organised in two consultation teams supervised on a bimonthly basis throughout the entire study by drs Miller and Reynolds respectively.; Patients randomised to EUC will received standard care (16 weeks) at five participating child and adolescent outpatient clinics from therapists not trained in or practising DBT. According to pilot study data EUC will most likely consist of psychodynamic therapy, various forms of family therapy and supportive therapy.
Other intervention name(s): Psychosocial intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment