TEENS Multi-site Trial

NCT05179655 · tracked via the Priya Life Science Denmark tracker

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Phase

Not applicable

Started

2022-02-01

Last updated

2025-03-10

Condition(s) studied

Self-Injurious Behavior

Investigational drug(s) / intervention(s)

Emotion Regulation Individual Therapy for Adolescents (ERITA)Treatment as usual

Emotion 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.

Treatment 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.

Study 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

Sex

ALL

Min age

13 Years

Max age

17 Years

Healthy volunteers

Inclusion Criteria: * ≥ 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 Criteria: * 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.

Primary outcome measure(s)

Non-suicidal self-injury episodes — End of treatment after 12 weeks and 6 months follow-up
Non-suicidal self-injury within the last four weeks, at end of intervention (12 weeks) by blinded outcome assessment by phone or video conference measured by Deliberate Self-Harm Inventory

Trial sites (4)

Facility	City	Region	Status
Child and Adolescent Mental Health Services	Aalborg	Denmark	Not Yet Recruiting
Child and Adolescent Mental Health Services Southern Region Denmark	Odense	Denmark	Recruiting
Child and Adolescent Mental Health Services in Region Zealand	Roskilde	Denmark	Not Yet Recruiting
Team for Self-injury, Child and Adolescent Mental Health Services, B195	Copenhagen	Ø	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05179655 on ClinicalTrials.gov ↗ ← All trials in Denmark