Effects of Internet-based ERITA Added to TAU in Young People With Non-Suicidal Self-Injury (TEENS) Feasibility Trial

Study Overview
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Brief Summary
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There has been a significant increase in non-suicidal self-injury the last decades especially among young people and treatment initiative are sparse. We aim to assess the feasibility of methods, procedures, and safety of internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as add on to treatment as usual (TAU) in 13-17-year-old patients with non-suicidal self-injury referred to psychiatric services.

Detailed Description
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Non-suicidal self-injury has disseminated almost epidemically through the last decades in young persons. There is no evidence of any experimental treatment for non-suicidal self-injury in adolescents, superior to treatment as usual. Patients with stigmatizing illness such as non-suicidal self-injury may find internet-based interventions more acceptable. The study is a feasibility trial, with a randomization procedure in a parallel group design. Patients will be recruited from Child- and Adolescent Mental Health Services (age 13 to 17 years). The experimental intervention is internet-based, and therapist guided; ERITA consists of online Emotion Regulation Individual Therapy for Adolescents (ERITA) as add-on to treatment as usual. Treatment as usual is provided by multidisciplinary teams in nine outpatient clinics within Child and Adolescent Mental Health Services in the Capital Region of Denmark. Feasibility of recruitment and trial procedures will be monitored as well as explorative clinical outcomes.

Official Title
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Treatment Effects of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) Added to Treatment as Usual in Young People With Non-Suicidal Self-Injury - (TEENS) Feasibility Trial

Conditions
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Non-suicidal Self-injury

Intervention / Treatment
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* Behavioral: Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 5 non-suicidal self-injury episodes in the past year and ≥ 1 non-suicidal self-injury episodes in the past month (DSM-5 criteria for a diagnosis of non-suicidal self-injury disorder in terms of frequency of NSSI). Age-appropriate literacy. Having at least one parent committing to participate in the parent program. Informed consent from parents/legal caretakers. Exclusion Criteria: Imminent suicidal risk assessed by clinicians during routine screening procedure (rated as no risk, elevated risk, imminent risk) in need of admission or other life saving strategies.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, feasibility trial including a randomization procedure in a parallel group design with blinded outcome assessment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based ERITA-DK<br>ERITA is a youth-adapted version of Emotion Regulation Group Therapy (ERGT), based on cognitive behavioral therapy (CBT), dialectical behavior therapy (DBT), and Acceptance and Commitment Therapy (ACT), which encounters emotional recognition and regulation, crisis strategies and skills training. The ERITA intervention is provided as add-on to TAU and consists of 12 weeks, manualized, therapist guided internet-based therapy. The intervention also provides six modules for the parents focusing on NSSI and other risk-taking behaviors, emotional awareness, and validation skills. The participants must complete one module every week while the parents must complete a module every second week. A mobile app is available to complement the online treatment. The app includes reminders of homework and skills and allows to report on both self-destructive behaviors and impulses daily. | Behavioral: Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)<br>* Please see description of experimental arm (arm one)<br>|
| Active Comparator: Treatment as Usual (TAU)<br>Child and Adolescent Mental Health Services (CAMHS) offer specialized treatment for children and adolescents. TAU encounters a variety of clinical treatment and assessment offers, representing a highly inhomogeneous group of treatments, for instance: Pharmacological treatment, Family-Based Treatment (FBT), Cognitive Behavioral Therapy, supportive counselling and psychoeducation. Throughout the trial course the treatment responsibility is handled by clinicians providing TAU. | Behavioral: Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)<br>* Please see description of experimental arm (arm one)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of follow-up | Completion of follow-up will be defined as completing at least one clinical outcome (non-suicidal self-injury events) at end of intervention. If the number participants with completed outcomes is 26 out of 30, the fraction will be 87%, 95% CI 75% to 99%. A follow-up fraction of 87% or more will be acceptable for a future trial while a fraction below 75% will impose serious problems of interpreting the trial result in a future large pragmatic trial. | End of treatment at 12 weeks | 
| The fraction of eligible participants who consent to inclusion and randomization | We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomized persons. If the number of participants randomized out of the number of eligible persons is 30 out of 75, the fraction will be 40%, 95% confidence interval (CI) will be: 29% to 51%. A randomization fraction of 29% or more will be acceptable for a future trial, while a fraction below 29% will impose serious problems of recruitment for a future large pragmatic trial. | End of treatment at 12 weeks | 
| Compliance | Compliance with the experimental intervention will be defined as completing at least six of 12 ERITA sessions. ERITA will automatically register time for login and save the exercises that have been completed. If the number of compliant experimental participants is 11 out of 15, the fraction will be 73%, 95% CI 51% to 96%. A compliance fraction of 51% or more will be acceptable for a future trial while a fraction below 51% will impose serious problems of interpreting the trial result in a future large pragmatic trial. | End of treatment at 12 weeks | 
| Non-suicidal self-injury as explorative primary clinical outcome | Non-suicidal self-injury, assessed at baseline and end of therapy (12 weeks) by blinded outcome assessment by phone with Deliberate Self-Harm Inventory (DSHI-Y) | End of treatment at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as explorative secondary clinical outcomes | Quality of life at 12 weeks, assessed with Kidscreen-10. 5-point Likert scale, range: not at all, a little, modearte, much, very much. | End of treatment at 12 weeks | 
| Symptoms of depression, anxiety and stress as explorative secondary clinical outcomes | Symptoms of depression, anxiety and stress at 12 weeks, assessed with Depression Anxiety Stress Scale (DASS-21). 4-point Likert scale, range: did not apply to me, applied to me to some degree, applied to me to a considerable degree, applied to me much/most of the time. Totale range for subscores: 0-42. Higher scores reflects worse outcome. | End of treatment at 12 weeks | 
| Non-suicidal self-injury as dichotomous variables as explorative secondary clinical outcome | Non-suicidal self-injury as dichotomous variables (Yes/No) | End of treatment at 12 weeks | 
| Number of sick days the last month as explorative secondary clinical outcome | Number of sick days the last month | End of treatment at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-suicidal Self-injury, Internet-based intervention