RecruitingNot ApplicableNCT05179655

TEENS Multi-site Trial

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Enrollment

356 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Self-Injurious Behavior

Summary

Emotion Regulation Individual Therapy for Adolescents, also called ERITA, is a youth friendly online therapy aiming to provide skills and train emotion regulation. The aim of the TEENS Multi-site Trial is to investigate the effect of ERITA, including an app, as add-on to treatment as usual in young patients referred to Mental Health Services. We expect 356 families to participate from three designated Regions in Denmark.

Eligibility

Min Age: 13 YearsMax Age: 17 Years

Inclusion Criteria4

≥ 5 non-suicidal self-injury episodes in the past year and ≥ 1 non-suicidal self-injury episodes in the past month assessed by the Deliberate Self-Harm Inventory, Youth version (DSHI-Y).
Age-appropriate literacy assessed by referring clinicians and the self-injury team, i.e. age between 13 and 17.
Having at least one parent committing to participate in the parent program.
Informed consent from parents/legal caretakers and assent from participants above 15 years of age.

Exclusion Criteria3

Imminent suicidal risk assessed by clinicians during routine screening procedure (that can be rated as no risk, elevated risk, or imminent risk) in need of admission or other life saving strategies.
Lack of informed consent from parents/legal caretakers.
Lack of informed assent from the participant above 15 years of age.

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Interventions

BEHAVIORALEmotion Regulation Individual Therapy for Adolescents (ERITA)

The ERITA intervention as add-on to TAU consists of 11 weeks, manualized online therapy based on the methods of Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), and Acceptance and Commitment Therapy (ACT) adapted for youth. The ERITA content consists of psychoeducation, emotion recognition, awareness training and theory of emotion regulation, including acceptance and validation skills.

OTHERTreatment as usual

Within Mental Health Services in Denmark child and adolescent psychiatrists provide specialized treatment for young psychiatric patients as outpatient services. In this trial the control intervention is treatment as usual (TAU) and consists of clinical assessment and treatment for patient's current primary psychiatric condition. TAU encounters a variety of clinical treatment and assessment offers, however, all within the field of expertise in child and adolescent psychiatry; out-patient care may consist of treatment for OCD, eating disorders, psychoses or affective disorders. TAU may consist of pharmacological treatment, Family-Based Treatment (FBT), Cognitive Behavioral Therapy (CBT), supportive counselling and/or psychoeducation.