Treatment for Adolescents With Deliberate Self Harm

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lars Mehlum, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00675129
First received: May 6, 2008
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention Phase
Intentional Self Harm
Behavioral: Dialectical behavioral therapy for adolescents (DBT-A)
Behavioral: Treatment as usual
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial for Repetitive Deliberate Self-harm and Suicidal Behaviours Among Norwegian Adolescents: a Comparison Between Dialectical Behaviour Therapy Adapted for Adolescents (DBT-A) and Enhanced Usual Care (EUC)

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm [ Time Frame: 16 weeks and 68 weeks ] [ Designated as safety issue: Yes ]
  • Severity of suicidal ideation, level of depressive symptoms [ Time Frame: 16 weeks and 68 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of deliberate self-harm behavior [ Time Frame: 16 weeks and 68 weeks ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: May 2008
Estimated Study Completion Date: September 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dialectical behavioral therapy
Behavioral: Dialectical behavioral therapy for adolescents (DBT-A)

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.

Active Comparator: 2
Enhanced Usual Care (standard care plus monitoring and patient safety protocol implemented)
Behavioral: Treatment as usual
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 Name: Psychosocial intervention

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of repeated deliberate self harm (last episode within last months)
  • Satisfies at least 2 criteria of DSM-IV Borderline Personality Disorder (as measured by SCID-II) in addition to the self-destructive criterion.

Or: Satisfies at least 1 criterion + 2 criteria scored below threshold (score 2) of DSM-IV Borderline Personality Disorder (as measured by SCID-II) in addition to the self-destructive criterion.

Exclusion Criteria:

  • Psychotic disorders
  • Anorexia Nervosa
  • Substance dependence disorder
  • Mental retardation (IQ less than 70)
  • Asperger syndrome/autism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675129

Locations
Norway
Suicide Research and Prevention Unit/University of Oslo
Oslo, Norway, 0320
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Lars Mehlum, Professor Suicide Research and Prevention Unit/University of Oslo
  More Information

Additional Information:
Publications:
Linehan, M.M. (1993a). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press
Linehan, M.M. (1993b). Skills training manual for treating borderline personality disorder. New York: Guilford Press

Responsible Party: Lars Mehlum, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00675129     History of Changes
Other Study ID Numbers: SHDIR-04-627
Study First Received: May 6, 2008
Last Updated: March 7, 2013
Health Authority: Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 22, 2014