The overarching aim of this study is to develop and evaluate a new blended treatment format, which combines face-to-face and digital treatment components, for Emotion Regulation Individual Therapy for Adolescents (ERITA). This brief, transdiagnostic, and blended treatment targeting nonsuicidal self-injury (NSSI) - referred to as blended ERITA - will be specifically designed for adolescents with NSSI and low levels of functioning within intensive outpatient psychiatric services. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.
12-17 years old
At least one NSSI episode in the past three months
A parent willing to engage in the parent program
Global functioning corresponding to a rating ≤50 of the Children's Global Assessment Scale (CGAS)
Immediate suicide risk
Social problems needing immediate intervention (e.g., violence within the family)
Other psychiatric disorder or symptoms requiring immediate treatment (e.g., severe anorexia nervosa, acute psychosis, severe substance abuse)
Ongoing dialectical behavior therapy for adolescents
Parallel
Blended ERITA
BehavioralBlended ERITA is an acceptance-based behavioral therapy. The goal of ERITA is to reduce self-injury through learning and using other ways to regulate emotions. ERITA includes both an adolescent treatment and a separate parent course. The adolescent treatment includes skills training in emotional awareness, impulse control, emotional acceptance, emotional willingness, emotional modulation effectiveness and flexibility, validation, and valued direction. The parent course includes skills training in emotional awareness, validation, self-validation, and behavioral activation. The adolescent treatment is 11 modules, and the parent course is six. The modules include text, videos, and audio resources. The family and therapist decide on how to combine sessions with digital material based on preferences and needs.
Treatment as Usual (TAU)
BehavioralTreatment as usual (TAU) will constitute treatment for NSSI according to local clinical guidelines.
Concomitant care
Other interventionParticipants are free to receive concomitant care (counselling or medication) in addition to self-injury treatment according to their needs during the trial.
Degree of participation in data collection
Proportion of adolescents completing the primary clinical outcome, Deliberate Self-harm Inventory - Youth version, either through interview or self-report questionnaire at one-month post-treatment.
Treatment completion
Proportion of adolescents completing ≥ six ERITA modules. Only in the experimental condition. Clinician-rated
Therapist time
Therapists will report time for having sessions with adolescents and/or parents or giving feedback on the digital platform. Only in the experimental condition.
Credibility/Expectancy Questionnaire (CEQ)
CEQ measures treatment credibility and expectancy. Scale points range from 0-9, and 0-100%, where higher scores indicate greater credibility and expectancy. Self-rated by adolescents. Only in the experimental condition.
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
The DSHI-Y is a youth-adaptation of the DSHI and measures the six most common NSSI methods. The primary clinical outcome will be the proportion of treatment remission. Remission will be defined as the absence of NSSI in the past month and measured dichotomously (yes/no). The primary data source will be blinded assessor-rated DSHI-Y. If these data are missing, self-reported DSHI-Y will be used.
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
The DSHI-Y measures the frequency of the most common NSSI behaviors. Change in NSSI frequency from baseline to respective follow-up will be a secondary outcome. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.
Difficulties in Emotion Regulation Scale - 16 items version (DERS-16)
The DERS-16 measures difficulties in emotion regulation. The total score ranges from 16 to 80, with higher scores indicating greater difficulties. Self-rated (adolescent and parent).
Clinical Global Assessment Scale (CGAS)
The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Clinician-rated.
Credibility/Expectancy Questionnaire (CEQ) - 1 item version
CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent).
Columbia-Suicide Severity Rating Scale (C-SSRS) - 6 item version
The C-SSRS - 6 item version measures the frequency and severity of suicidal ideation and behaviors. Clinician-rated.
Care consumption
Degree and type of care consumption as registered by the health care. Registry data from the local Stockholm register for Child and Adolescent Mental Health Services.
Inventory of Statements About Self-injury (ISAS)
ISAS measures frequency, function, age of onset, experience of, and willingness to stop engaging in self-injury. There are 39 items describing common functions of self-injury. Participants are asked to rate if a certain function applies to them, by marking the statement as "Not relevant", "Partly relevant", or "Very relevant". Self-rated (adolescent).
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Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
