Treatment for Adolescents With Deliberate Self Harm - Full Text View

Sponsor:	Ullevaal University Hospital
Collaborator:	University Hospital, Aker
Information provided by:	Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT00675129

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 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.

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

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 Treatment-as-usual

Resource links provided by NLM:

MedlinePlus related topics: Suicide

U.S. FDA Resources

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: 20 weeks and 72 weeks ] [ Designated as safety issue: Yes ]
Severity of suicidal ideation, level of depressive symptoms [ Time Frame: 20 weeks and 72 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: 20 weeks and 72 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (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 Treatment as usual	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. Other Name: Psychosocial intervention

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

Treatment as usual

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.

Other Name: Psychosocial intervention

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

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

Contacts

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

Locations

Norway
Suicide Research and Prevention Unit/University of Oslo	Recruiting
Oslo, Norway, 0320
Principal Investigator: Lars Mehlum, Dr med

Sponsors and Collaborators

Ullevaal University Hospital

University Hospital, Aker

Investigators

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

Responsible Party:	Lars Mehlum/MD, Professor, University of Oslo
ClinicalTrials.gov Identifier:	NCT00675129 History of Changes
Other Study ID Numbers:	SHDIR-04-627
Study First Received:	May 6, 2008
Last Updated:	July 18, 2011
Health Authority:	Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:

Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 12, 2012