Treatment for Adolescents With Deliberate Self Harm

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ClinicalTrials.gov Identifier: NCT00675129

Recruitment Status : Completed

First Posted : May 8, 2008

Last Update Posted : October 23, 2014

Sponsor:

Information provided by (Responsible Party):

Lars Mehlum, Oslo University Hospital

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.

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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	77 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (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)
Study Start Date :	May 2008
Actual Primary Completion Date :	February 2013
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm Suicide

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Arm

Intervention/treatment

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

Outcome Measures

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 ]
Severity of suicidal ideation, level of depressive symptoms [ Time Frame: 16 weeks and 68 weeks ]

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675129

Locations

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Norway
Suicide Research and Prevention Unit/University of Oslo
Oslo, Norway, 0320

Sponsors and Collaborators

Oslo University Hospital

Investigators

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Principal Investigator:	Lars Mehlum, Professor	Suicide Research and Prevention Unit/University of Oslo

More Information

Additional Information:

Information about the research project in Norwegian This link exits the ClinicalTrials.gov site

The Suicide Research and Prevention Unit/University of Oslo - information in English This link exits the ClinicalTrials.gov site

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

Miller, A.L., Rathus J.H., Linehan, M.M. (2007). Dialectical behavioral therapy with suicidal adolescents. New York: Guilford Press

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:CD013667. doi: 10.1002/14651858.CD013667.pub2.

Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Jørgensen 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:CD012955. doi: 10.1002/14651858.CD012955.pub2.

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.

Mehlum L, Ramberg M, Tørmoen AJ, Haga E, Diep LM, Stanley BH, Miller AL, Sund AM, Grøholt 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.

Mehlum L, Tørmoen AJ, Ramberg M, Haga E, Diep LM, Laberg S, Larsson BS, Stanley BH, Miller AL, Sund AM, Grøholt 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.

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Responsible Party:	Lars Mehlum, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT00675129
Other Study ID Numbers:	SHDIR-04-627
First Posted:	May 8, 2008 Key Record Dates
Last Update Posted:	October 23, 2014
Last Verified:	October 2014

Additional relevant MeSH terms:

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Self Mutilation Self-Injurious Behavior Behavioral Symptoms Wounds and Injuries

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