Treatment for Adolescents With Deliberate Self Harm - Tabular View

Tracking Information

First Received Date ^ICMJE

May 6, 2008

Last Updated Date

March 27, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00675129 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment for Adolescents With Deliberate Self Harm

Official Title ^ICMJE

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 Treatment-as-Usual

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 treatment-as-usual (TAU). 150 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 TAU. 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 TAU.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Intentional Self Harm

Intervention ^ICMJE

Behavioral: Dialectical behavioral therapy for adolescents (DBT-A)
Behavioral: Treatment as usual

Study Arms / Comparison Groups

Experimental: Dialectical behavioral therapy
Active Comparator: Treatment as usual

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Lars Mehlum, Professor	47-22-92-3473	lars.mehlum@medisin.uio.no
Contact: Egil Haga	47-22-92-3442	egil.haga@medisin.uio.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00675129

Responsible Party

Lars Mehlum/MD, Professor, University of Oslo

Study ID Numbers ^ICMJE

SHDIR-04-627

Study Sponsor ^ICMJE

Ullevaal University Hospital

Collaborators ^ICMJE

University Hospital, Aker

Investigators ^ICMJE

Principal Investigator:

Lars Mehlum, Professor

Suicide Research and Prevention Unit/University of Oslo

Information Provided By

Ullevaal University Hospital

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP