Clinical trial NCT05179655: TEENS Multi-site Trial
Official title: TEENS Multi-site Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self-Injurious Behavior
Keywords: Internet-based intervention
Online therapy
Emotion regulation
ERITA
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Region of Southern Denmark
name: Region Zealand
First posted: 2022-01-05
Enrollment: 356
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Non-suicidal self-injury episodes
timeFrame: End of treatment after 12 weeks and 6 months follow-up
Secondary outcomes:
measure: Kidscreen-10; Quality of life
timeFrame: End of treatment after 12 weeks and 6 months follow-up
measure: Symptoms of depression, anxiety and stress
timeFrame: End of treatment after 12 weeks and 6 months follow-up
measure: Non-suicidal self-injury as dichotomous (any/none)
timeFrame: End of treatment after 12 weeks and 6 months follow-up
Other outcomes:
measure: Difficulties in emotion regulation
timeFrame: End of treatment after 12 weeks and 6 months follow-up
measure: Borderline Symptom List (BSL-supplement).
timeFrame: Through trial periode (every three weeks, end of treatment after 12 weeks and 6 months follow-up)
measure: Suicidal ideations
timeFrame: Through trial period (every three weeks, end of treatment after 12 weeks and 6 months follow-up)
measure: Coping with Children's Negative Emotions - Adolescents
timeFrame: End of treatment after 12 weeks and 6 months follow-up
measure: Coping with Children's Negative Emotions - Parents
timeFrame: End of treatment after 12 weeks and 6 months follow-up
measure: Negative Effects Questionnaire
timeFrame: Through trial periode (every three weeks and end of treatment after 12 weeks)
measure: Working Alliance
timeFrame: Through the trial period (week four and eight)
Locations:
city: Aalborg
country: Denmark
facility: Child and Adolescent Mental Health Services
city: Copenhagen
country: Denmark
facility: Team for Self-injury, Child and Adolescent Mental Health Services, B195
city: Odense
country: Denmark
facility: Child and Adolescent Mental Health Services Southern Region Denmark
city: Roskilde
country: Denmark
facility: Child and Adolescent Mental Health Services in Region Zealand
Study officials:
affiliation: Mental Health Services Capital Region Denmark
name: Anne K Pagsberg, Professor
role: STUDY_CHAIR
References: