TEENS Multi-site Trial

Mental Health Services in the Capital Region, Denmark

Status: Enrolling

Conditions: Self-Injurious Behavior

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05179655

H-21035306

Details and patient eligibility

About

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.

Full 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.

Enrollment: 356 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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356 participants in 2 patient groups

ERITA + TAU (Treatment as usual)

Experimental group

Description:

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

Treatment:

Behavioral: Emotion Regulation Individual Therapy for Adolescents (ERITA)

Other: Treatment as usual

TAU (Treatment as usual)

Other group

Description:

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).

Treatment:

Other: Treatment as usual