Clinical trial NCT06315075: Dialectical Behavior Therapy for Adolescents with Self-harm and Suicidal Behavior- an Open Trial
Official title: Dialectical Behavior Therapy for Adolescents with Self-harm and Suicidal Behavior- an Open
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self-harm
Suicidal Ideation
Suicide and Self-harm
Keywords: Suicide and Self-harm
Adolescents
Dialectical behavior therapy for adolescents
Routine clinical practice
Effectiveness study
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 140
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, uncontrolled, pre-post-one year follow-up study
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lifetime Parasuicide Count Interview
timeFrame: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up
measure: Number of participants in need of emergency department visits caused by suicidal behavior
timeFrame: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up
Secondary outcomes:
measure: Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ)
timeFrame: pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up
measure: Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10)
timeFrame: pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up
measure: Barriers to Treatment Participation Scale (BTPS) score
timeFrame: pre, at dropout at any time between session 1 and end of treatment at session 20.
measure: Perceived benefit of skills training in DBT-A measured by a study specific questionnaire.
timeFrame: At dropout at any time between session 1 and end of treatment at session 20, or for completers after 20 weeks DBT-A ("post"),
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Dept. of child and adolescent psychiatry, Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Gro Janne H. Wergeland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: