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

Non-suicidal Self-injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243603
• Other study ID #: H-19042904
• Status: Completed
• Phase: N/A
• Start date: May 11, 2020
• Est. completion date: January 22, 2021

Study information

• Verified date: May 2021
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Non-suicidal Self-injury
• Self-Injurious Behavior
• Wounds and Injuries

Intervention

Behavioral:
• Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)
Please see description of experimental arm (arm one)

Locations

Country	Name	City	State
Denmark	Team for Self-injury, Child and Adolescent Mental Health Services, B195	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Copenhagen Trial Unit, Center for Clinical Intervention Research, Karolinska Institutet

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difficulties in emotion regulation as further explorative clinical outcome	Difficulties in emotion regulation, assessed weekly during 12 weeks with Difficulties in Emotion Regulation Scale (DERS-16). 5-point Likert scale, range: almost never, some times, half of the time, most of the time, all the time. Total scores range from 16 to 80, with higher scores reflecting grater levels of emotion dysregulation.	At end of treatment and once a week for 12 weeks
Other	Indirect self-destructive behaviours as further explorative clinical outcome	Indirect self-destructive behaviours at 12 weeks, assessed with Borderline Symptom List (BSL-supplement). 5-point Likert scale, range: not at all, once, 2-3 times, 4-6 times, daily or more often. Total scores range from 0-44 and higher scores reflect worse outcome.	End of treatment at 12 weeks
Other	Suicidal ideations, plans and actions as further explorative clinical outcome	Suicidal ideations, plans and actions at 12 weeks, assessed with Columbia (C-SSRS). Dichotomous outcome yes/no; if yes intensity is rated on a 5-point Likert scale, total score range: 2-25. Higher scores reflect worse outcome.	End of treatment at 12 weeks
Other	Parents' ability to cope with children's negative emotions as further explorative clinical outcome	Adolescent's perception of Parents' ability to cope with children's negative emotions at 6 weeks and 12 weeks, assessed with The Coping with Children's Negative Emotions Scale (CCNES-APP). 7-point Likert scale, Range from very unlikely to very likely. Six Sub scales with total score range: 0-42. The sub scale are inversely related.	After week six and week 12
Other	Parents' perceived ability to cope with children's negative emotions as further explorative clinical outcome	Parents' perceived ability to cope with children's negative emotions at 6 weeks and 12 weeks, assessed with The Coping with Children's Negative Emotions Scale Adolescent (CCNES-A). 7-point Likert scale, Range from very unlikely to very likely. Six Sub scales with total score range: 0-42. The sub scale are inversely related.	After week six and week 12
Other	Adverse Events as further explorative clinical outcome	Adverse Events 4, 8 and 12 weeks assessed with Negative Effects Questionnaire (NEQ). Dichotomous outcomes as yes/no; if yes then a 5-point Likert scale of the impact, range not at all, a little, moderately, much, very much. The total score range 0-80. Higher scores reflect worse outcome.	After week 4, 8, and 12
Other	Strengths and difficulties as further explorative clinical outcome	Strengths and difficulties assessed by Strengths and difficulties questionnaire (SDQ) at 4, 8, and 12 weeks. 3-point Likert scale, range: doesn't fit, fits moderately, fits very much. Total score range 0-40. Sub scales of strengths and difficulties that are inversely related.	After week 4, 8, and 12
Other	Working alliance with online therapist as further explorative clinical outcome	Working alliance with online therapist assessed with Working Alliance Inventory (WAI-SR). 5-point Likert scale, range: seldom, some times, fairly often, very often, always. Total score range 12-60. Higher scores reflect higher working alliance/better outcome.	After week 4, 8, and 12
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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