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Sponsors and Collaborators: |
Ullevaal University Hospital University Hospital, Aker |
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Information provided by: | Ullevaal University Hospital |
ClinicalTrials.gov Identifier: | NCT00675129 |
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:
Condition | Intervention | Phase |
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Intentional Self Harm |
Behavioral: Dialectical behavioral therapy for adolescents (DBT-A) Behavioral: Treatment as usual |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
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 Treatment-as-Usual |
Estimated Enrollment: | 150 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Dialectical behavioral therapy
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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. |
2: Active Comparator
Treatment as usual
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Behavioral: Treatment as usual
Patients randomised to TAU 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 TAU will most likely consist of psychodynamic therapy, various forms of family therapy and supportive therapy.
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Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
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 |
Norway | |
Suicide Research and Prevention Unit/University of Oslo | Recruiting |
Oslo, Norway, 0320 | |
Principal Investigator: Lars Mehlum, Dr med |
Principal Investigator: | Lars Mehlum, Professor | Suicide Research and Prevention Unit/University of Oslo |
Responsible Party: | University of Oslo ( Lars Mehlum/MD, Professor ) |
Study ID Numbers: | SHDIR-04-627 |
Study First Received: | May 6, 2008 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00675129 History of Changes |
Health Authority: | Norway: Norwegian Social Science Data Services |
Behavioral Symptoms Self-Injurious Behavior |
Behavioral Symptoms Self-Injurious Behavior |