Treatment for Adolescents With Deliberate Self Harm
Primary Purpose
Intentional Self Harm
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Dialectical behavioral therapy for adolescents (DBT-A)
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Intentional Self Harm
Eligibility 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
Sites / Locations
- Suicide Research and Prevention Unit/University of Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Dialectical behavioral therapy
Enhanced Usual Care (standard care plus monitoring and patient safety protocol implemented)
Outcomes
Primary Outcome Measures
Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm
Severity of suicidal ideation, level of depressive symptoms
Secondary Outcome Measures
Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of deliberate self-harm behavior
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00675129
Brief Title
Treatment for Adolescents With Deliberate Self Harm
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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:
There had been no attrition from research assessments
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intentional Self Harm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dialectical behavioral therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Enhanced Usual Care (standard care plus monitoring and patient safety protocol implemented)
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavioral therapy for adolescents (DBT-A)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
Psychosocial intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Severity of suicidal ideation, level of depressive symptoms
Time Frame
16 weeks and 68 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Mehlum, Professor
Organizational Affiliation
Suicide Research and Prevention Unit/University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suicide Research and Prevention Unit/University of Oslo
City
Oslo
ZIP/Postal Code
0320
Country
Norway
12. IPD Sharing Statement
Citations:
Citation
Linehan, M.M. (1993a). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press
Results Reference
background
Citation
Linehan, M.M. (1993b). Skills training manual for treating borderline personality disorder. New York: Guilford Press
Results Reference
background
Citation
Miller, A.L., Rathus J.H., Linehan, M.M. (2007). Dialectical behavioral therapy with suicidal adolescents. New York: Guilford Press
Results Reference
background
PubMed Identifier
33677832
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
Results Reference
derived
PubMed Identifier
32368793
Citation
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Results Reference
derived
PubMed Identifier
29093819
Citation
Ramleth RK, Groholt B, Diep LM, Walby FA, Mehlum L. The impact of borderline personality disorder and sub-threshold borderline personality disorder on the course of self-reported and clinician-rated depression in self-harming adolescents. Borderline Personal Disord Emot Dysregul. 2017 Oct 31;4:22. doi: 10.1186/s40479-017-0073-5. eCollection 2017.
Results Reference
derived
PubMed Identifier
27015720
Citation
Mehlum L, Ramberg M, Tormoen AJ, Haga E, Diep LM, Stanley BH, Miller AL, Sund AM, Groholt B. Dialectical Behavior Therapy Compared With Enhanced Usual Care for Adolescents With Repeated Suicidal and Self-Harming Behavior: Outcomes Over a One-Year Follow-Up. J Am Acad Child Adolesc Psychiatry. 2016 Apr;55(4):295-300. doi: 10.1016/j.jaac.2016.01.005. Epub 2016 Jan 27.
Results Reference
derived
PubMed Identifier
25245352
Citation
Mehlum L, Tormoen AJ, Ramberg M, Haga E, Diep LM, Laberg S, Larsson BS, Stanley BH, Miller AL, Sund AM, Groholt B. Dialectical behavior therapy for adolescents with repeated suicidal and self-harming behavior: a randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Oct;53(10):1082-91. doi: 10.1016/j.jaac.2014.07.003. Epub 2014 Jul 22.
Results Reference
derived
Links:
URL
http://www.med.uio.no/ipsy/ssff/forskning/dbt/forskningsprosjekt_dbt.html
Description
Information about the research project in Norwegian
URL
http://www.med.uio.no/ipsy/ssff/english/index_english.html
Description
The Suicide Research and Prevention Unit/University of Oslo - information in English
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Treatment for Adolescents With Deliberate Self Harm
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