Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorHaukeland University Hospital
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Intellectual disability
Significant learning or language impairments
Autism spectrum disorder
Anorexia Nervosa
Trial design
Design model
Single group
Treatments tested in this trial
Dialectical behavior therapy for adolescents (DBT-A)
BehavioralA 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.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: DBT-AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional Assessment of Self-Mutilation (FASM)
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. In addition, FASM includes functional assessment of self-mutilation.
Time frame
pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up2
Number of participants in need of emergency department visits caused by suicidal behavior
Medical record data extraction
Time frame
pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-upSecondary outcomes
1
Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ)
Depressive symptoms. SMFQ includes 13 items, measured on a 0-2 Likert scale, with higher scores indicating a higher level of depressive symptoms.
Time frame
pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up2
Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10)
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.
Time frame
pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up3
Barriers to Treatment Participation Scale (BTPS) score
The BTPS questionnaire evaluate reasons for treatment discontinuation, and treatment participation barriers.
Time frame
pre, at dropout at any time between session 1 and end of treatment at session 20.4
Perceived benefit of skills training in DBT-A measured by a study specific questionnaire.
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.
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"),Sponsors and contacts
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Source ClinicalTrials.gov