TEENS Multi-site Trial

NCT05179655 | Recruiting

• 1 other identifier: H-21035306
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 4

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.

Conditions

Self-Injurious Behavior

Keywords

Internet-based intervention; Online therapy; Emotion regulation; ERITA

Outcome Measures

Primary Outcomes (1)

• Non-suicidal self-injury episodes

  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

  End of treatment after 12 weeks and 6 months follow-up

Secondary Outcomes (3)

• Kidscreen-10; Quality of life

  End of treatment after 12 weeks and 6 months follow-up

• Symptoms of depression, anxiety and stress

  End of treatment after 12 weeks and 6 months follow-up

• Non-suicidal self-injury as dichotomous (any/none)

  End of treatment after 12 weeks and 6 months follow-up

Other Outcomes (7)

• Difficulties in emotion regulation

  End of treatment after 12 weeks and 6 months follow-up

• Borderline Symptom List (BSL-supplement).

  Through trial periode (every three weeks, end of treatment after 12 weeks and 6 months follow-up)

• Suicidal ideations

  Through trial period (every three weeks, end of treatment after 12 weeks and 6 months follow-up)

Study Arms (2)

ERITA + TAU (Treatment as usual)

EXPERIMENTAL

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

Behavioral: Emotion Regulation Individual Therapy for Adolescents (ERITA); Other: Treatment as usual

TAU (Treatment as usual)

OTHER

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).

Other: Treatment as usual

Interventions

Emotion Regulation Individual Therapy for Adolescents (ERITA) 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.

Also known as: ERITA

ERITA + TAU (Treatment as usual)

Treatment as usual 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.

ERITA + TAU (Treatment as usual); TAU (Treatment as usual)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Region of Southern Denmark: collaborator
• Region Zealand: collaborator

Study Sites (4)

Child and Adolescent Mental Health Services

Aalborg, 9000, Denmark

NOT YET RECRUITING

Child and Adolescent Mental Health Services Southern Region Denmark

Odense, 5000, Denmark

RECRUITING

Child and Adolescent Mental Health Services in Region Zealand

Roskilde, 4000, Denmark

NOT YET RECRUITING

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

Copenhagen, Ø, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior; Emotional Regulation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Anne K Pagsberg, Professor

  Mental Health Services Capital Region Denmark

  STUDY CHAIR

Central Study Contacts

Britt Morthorst

CONTACT

0045 27521085; britt.reuter.morthorst@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, a blinding of participants and therapists is not possible. Blinded outcome assessment will be performed by a trained researcher. Statistical analyses will be performed by two blinded statisticians presenting independent reports and with the intervention groups coded as A and B.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Senior researcher

Model Details: An investigator-initiated, multi-site randomised, parallel group, clinical superiority trial with blinded outcome assessment investigating the internet-based intervention ERITA as add-on to TAU compared to TAU alone in NSSI engaging psychiatric, outpatient youth. Participants will be randomised at the allocation ratio 1:1. Randomisation will be handled centrally at the Copenhagen Trial Unit (CTU) using a computer-generated allocation sequence with a varying block size concealed from the investigators. The allocation sequence will be stratified NSSI at baseline 1-10 versus 11≤ episodes in the past month, and trial site. CTU will generate the allocation sequence and investigators at the clinical trial sites will assign participants to the intervention groups using an OpenClinica web-based system developed by the CTU

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 5, 2022
• Study Start: February 1, 2022
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2025

Record last verified: 2024-11

Locations

DK (4)