TEENS Multi-site Trial

NCT ID: NCT05179655

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

Background: A prevalence of non-suicidal self-injury is not easily assessed; however, meta-analyses found a lifetime prevalence of 17% in non-clinical student samples. This estimate increases to 50-74% in psychiatric populations. Non-suicidal self-injury is an important predictor for later suicidal behavior and death by suicide. Although non-suicidal self-injury is highly prevalent, there is no evidence for specific treatment for non-suicidal self-injury in adolescents. Reviews find that internet-based interventions guided by a therapist are effective for several psychiatric disorders such as anxiety and depression in adult population. Patients with stigmatizing illnesses such as non-suicidal self-injury may be reluctant to seek help and adhere with treatment while internet-based interventions are more appealing. There is a need for trials investigating the effect of specialized interventions for non-suicidal self-injury in youth, including digital interventions.

Objective: To investigate the effect of an internet-based intervention, Emotion Regulation Individual Therapy for Adolescents (ERITA), as add-on to treatment as usual in 13-17-year-old patients with non-suicidal self-injury referred to Child- and Adolescent Mental Health Services with subsequent non-suicidal self-injury as primary outcome assessed by Deliberate Self-Harm Inventory - Youth. Further clinical outcomes such as quality of life, depression, anxiety and stress, as well as emotion regulation difficulties will be assessed as secondary outcomes.

Method and materials: This is a randomized, clinical, superiority, multicenter trial in a parallel group design. Patients will be recruited from Child- and Adolescent Mental Health Services in three of the Danish Regions: The trial inclusion period will be from primo 2022 to ultimo 2023. The experimental intervention is therapist guided internet-based ERITA provided exclusively online as add-on to treatment as usual in the experimental group. Treatment as usual is provided by multidisciplinary teams in outpatient clinics in all participating regions. We expect to include 356 participants and one of their parents.

Conditions

Self-Injurious Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ERITA + TAU (Treatment as usual)

The Emotion Regulation Individual Therapy for Adolescents (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

Group Type: EXPERIMENTAL

Emotion Regulation Individual Therapy for Adolescents (ERITA)

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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.

TAU (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 study the control intervention (TAU) consists of clinical assessment and treatment for patient's current primary psychiatric condition (referral condition and A-diagnosis).

Group Type: OTHER

Treatment as usual

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

ERITA

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role: collaborator

Region of Southern Denmark

OTHER

Sponsor Role: collaborator

Region Zealand

OTHER

Sponsor Role: collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Britt Reuter Morthorst

Associate Professor, Senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne K Pagsberg, Professor

Role: STUDY_CHAIR

Mental Health Services Capital Region Denmark

Locations

Child and Adolescent Mental Health Services

Aalborg, , Denmark

Site Status: NOT_YET_RECRUITING

Child and Adolescent Mental Health Services Southern Region Denmark

Odense, , Denmark

Site Status: RECRUITING

Child and Adolescent Mental Health Services in Region Zealand

Roskilde, , Denmark

Site Status: NOT_YET_RECRUITING

Team for Self-injury, Child and Adolescent Mental Health Services, B195

Copenhagen, Ø, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Britt Morthorst

Role: CONTACT

britt.reuter.morthorst@regionh.dk

0045 27521085

Facility Contacts

Marlene B Lauritsen, Professor

Role: primary

marlene.lauritsen@rn.dk

0045 97643317

Rikke T. Wesselhoeft, Assprofessor

Role: primary

rwesselhoeft@health.sdu.dk

0045 22 35 85 90

Pia Jeppesen, Professor

Role: primary

pijep@regionsjaelland.dk

0045 23969929

Lotte Rubæk, MHs

Role: primary

lotte.rubaek@regionh.dk

0045 38 64 10 98

Ida L Jørgensen, MHs

Role: backup

ida.lichtenstein.joergensen@regionh.dk

0045 38 64 10 98

Other Identifiers

H-21035306

Identifier Type: -

Identifier Source: org_study_id