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NCT Number: NCT06315075

Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial

The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are:

* to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A. * to investigate how well DBT-A works at 12 months follow-up * to investigate whether pre-treatment factors can predict who will benefit from treatment

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Key information

Conditions

Self-Harm Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide Suicide and Self-harm

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Self-harm and suicidal ideation are prevalent among adolescents and associated with major mental health problems and adverse life events. Dialectical behavior therapy for adolescents (DBT-A) is an empirically supported treatment for self-harm and suicidal ideation in adolescents. However, knowledge is scarce on the effectiveness, long-term outcomes, acceptability, and dropout of DBT-A when implemented and delivered as part of routine clinical practice in the Norwegian national health care system. The main aim of this study is to examine the outcomes from DBT-A in terms of self-harm episodes, suicide attempts, and emergency hospital admission, in addition to acceptability and dropout, when DBT-A is delivered at the Department of Child and adolescent psychiatry (PBU), Haukeland University Hospital (HUS). The study is an uncontrolled pre-post study with one-year follow-up and includes three aims: to evaluate outcomes of DBT-A up to three months post-treatment, at one-year follow-up, and to describe predictors of outcome for adolescents receiving DBT-A.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 13-18 years
  • Ongoing or a history of self-harm the last six months; current suicidal behavior (suicidal thoughts or at least one suicide attempt within the previous six months); at least three criteria of Diagnostic and Statistical Manual -5 (DSM-5) Borderline personality disorder (BPD), or the self-destruction criterion of DSM-5 BPD in addition to minimum two subthreshold criteria as assessed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (First et al., 2016)
  • Fluency in Norwegian
  • One parent/trusted adult that can participate together with the adolescent.

Exclusion criteria

  • Intellectual disability
  • Significant learning or language impairments
  • Autism spectrum disorder
  • Anorexia Nervosa
  • Any psychotic disorder
  • Substance abuse disorder. These patients will be offered treatment as usual at their local outpatient clinic.

Treatment and study plan

Dialectical behavior therapy for adolescents (DBT-A)

Behavioral

A 20-week DBT-A with a weekly individual session (45 minutes), a weekly session of multifamily skills training groups with a caregiver (120 minutes), and telephone consultation with individual therapists outside therapy sessions as needed. The treatment consists of four components and is delivered according to the manual except for the phone coaching that PBU offers workdays until 8 pm.

Other names: DBT-A

Primary outcomes

  1. Lifetime Parasuicide Count Interview

    Time frame: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up

    Number of self-harm episodes in the last four weeks categorized by intention and self-harm method, number of suicide attempts, and number of emergency department visits caused by suicidal behavior.

  2. Number of participants in need of emergency department visits caused by suicidal behavior

    Time frame: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up

    Medical record data extraction

Secondary outcomes

  1. Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ)

    Time frame: pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up

    Depressive symptoms. SMFQ includes 13 items, measured on a 0-2 Likert scale, with higher scores indicating a higher level of depressive symptoms.

  2. Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10)

    Time frame: pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up

    Kidscreen includes 10 items measured on a 5 point Likert scale and gives a global measure from 0-100 of health-related quality of life in addition to the individual aspects. Higher scores reflects higher health related quality of life.

  3. Barriers to Treatment Participation Scale (BTPS) score

    Time frame: pre, at dropout at any time between session 1 and end of treatment at session 20.

    The BTPS questionnaire evaluate reasons for treatment discontinuation, and treatment participation barriers.

  4. Perceived benefit of skills training in DBT-A measured by a study specific questionnaire.

    Time frame: At dropout at any time between session 1 and end of treatment at session 20, or for completers after 20 weeks DBT-A ("post"),

    Perceived benefit of skills training in DBT-A is a study-specific patient- and parent reported evaluation measure of perceived benefits of DBT-A components rated on a 0-5 Likert scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Mari Syversen, Psychol

CONTACT

[email protected]

+47 55975000

Gro Janne H. Wergeland, MD, PhD

CONTACT

[email protected]

+47 48176828

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Mar 18, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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