Treatment for Adolescents With Deliberate Self Harm

NCT00675129 | Completed Phase 2 DMC

• 1 other identifier: SHDIR-04-627
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Intentional Self Harm

Outcome Measures

Primary Outcomes (2)

• Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm

  16 weeks and 68 weeks

• Severity of suicidal ideation, level of depressive symptoms

  16 weeks and 68 weeks

Secondary Outcomes (1)

• Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of deliberate self-harm behavior

  16 weeks and 68 weeks

Study Arms (2)

1

EXPERIMENTAL

Dialectical behavioral therapy

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

2

ACTIVE COMPARATOR

Enhanced Usual Care (standard care plus monitoring and patient safety protocol implemented)

Behavioral: Treatment as usual

Interventions

Dialectical behavioral therapy for adolescents (DBT-A) BEHAVIORAL

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.

1

Treatment as usual BEHAVIORAL

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.

Also known as: Psychosocial intervention

2

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Psychotic disorders
• Anorexia Nervosa
• Substance dependence disorder
• Mental retardation (IQ less than 70)
• Asperger syndrome/autism

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Suicide Research and Prevention Unit/University of Oslo

Oslo, 0320, Norway

Location

Related Publications (9)

• Linehan, M.M. (1993a). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press

  BACKGROUND

• Linehan, M.M. (1993b). Skills training manual for treating borderline personality disorder. New York: Guilford Press

  BACKGROUND

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

  BACKGROUND

• Dibaj IS, Tormoen AJ, Klungsoyr O, Morken KTE, Haga E, Dymbe KJ, Mehlum L. Early remission of deliberate self-harm predicts emotion regulation capacity in adulthood: 12.4 years follow-up of a randomized controlled trial of adolescents with repeated self-harm and borderline features. Eur Child Adolesc Psychiatry. 2025 Jun;34(6):1837-1848. doi: 10.1007/s00787-024-02602-8. Epub 2024 Oct 29.

  PMID: 39470788 DERIVED

• 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.

  PMID: 33677832 DERIVED

• 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.

  PMID: 32368793 DERIVED

• 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.

  PMID: 29093819 DERIVED

• 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.

  PMID: 27015720 DERIVED

• 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.

  PMID: 25245352 DERIVED

Related Links

• Information about the research project in Norwegian
• The Suicide Research and Prevention Unit/University of Oslo - information in English

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Therapeutics; Psychosocial Intervention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lars Mehlum, Professor

  Suicide Research and Prevention Unit/University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 8, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 23, 2014

Record last verified: 2014-10

Locations

NO (1)