Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05179655
Other study ID # H-21035306
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date December 31, 2026

Study information

Verified date March 2023
Source Mental Health Services in the Capital Region, Denmark
Contact Britt Morthorst
Phone 0045 27521085
Email britt.reuter.morthorst@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 356
Est. completion date December 31, 2026
Est. primary completion date December 31, 2024
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 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Child and Adolescent Mental Health Services Aalborg
Denmark Team for Self-injury, Child and Adolescent Mental Health Services, B195 Copenhagen
Denmark Child and Adolescent Mental Health Services Southern Region Denmark Odense
Denmark Child and Adolescent Mental Health Services in Region Zealand Roskilde

Sponsors (4)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Difficulties in emotion regulation Difficulties in emotion regulation, assessed with Difficulties in Emotion Regulation Scale - 16 Item Version (DERS-16). DERS-16 has 16 items which each generates a score from 1 to 5. The results will be presented as one sum-score. The scores in this scale range from 16-80 with higher scores indicating greater emotion regulation difficulties. End of treatment after 12 weeks and 6 months follow-up
Other Borderline Symptom List (BSL-supplement). Indirect self-destructive behaviours assessed with Borderline Symptom List (BSL-supplement). BSL-supplement has 11 items which each generates a score from 0 to 4. The results will be presented as one sum-score. Through trial periode (every three weeks, end of treatment after 12 weeks and 6 months follow-up)
Other Suicidal ideations Suicidal ideations assessed by SIDAS. A five item scale with questions ranging from 0 to 10. Final sum score from 0-50. Through trial period (every three weeks, end of treatment after 12 weeks and 6 months follow-up)
Other Coping with Children's Negative Emotions - Adolescents Adolescent rated parents' ability to cope with children's negative emotions assessed with The Coping with Children's Negative Emotions Scale (CCNES-APP). 9 main items with 6 sub items (a to f) for each. Each sub item generates a score from 1 to 7. The results will be presented as mean-scores for the six subscales. End of treatment after 12 weeks and 6 months follow-up
Other Coping with Children's Negative Emotions - Parents Parent-rated perceived ability to cope with children's negative emotions assessed with The Coping with Children's Negative Emotions Scale Adolescent (CCNES-A). 9 main items with 6 sub items (a to f) for each. Each sub item generates a score from 1 to 7. The results will be presented as mean-scores for the six subscales. End of treatment after 12 weeks and 6 months follow-up
Other Negative Effects Questionnaire Adverse Events of therapy assessed with Negative Effects Questionnaire (NEQ). NEQ has 20 items, with 5 sub-items The results will be presented as means and standard deviations. Through trial periode (every three weeks and end of treatment after 12 weeks)
Other Working Alliance The alliance percieved between the participant and the therapist, WAI-SR Through the trial period (week four and eight)
Primary 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 Kidscreen-10; Quality of life Quality of life at 12 weeks, assessed with Kidscreen-10, a five point likert scale, range: not at all, a little, moderate, much, very much. End of treatment after 12 weeks and 6 months follow-up
Secondary Symptoms of depression, anxiety and stress Symptoms of depression, anxiety and stress at 12 weeks, assessed with Depression Anxiety Stress Scale (DASS-21) presented as analyses for each subgroup item. Four 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. Total rage for subscores: 0-42. Higher scores reflect worse outcome. End of treatment after 12 weeks and 6 months follow-up
Secondary Non-suicidal self-injury as dichotomous (any/none) The proportion of participants with any NSSI during the past four weeks. End of treatment after 12 weeks and 6 months follow-up
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02914847 - Imaginator: a Pilot of Brief Functional Imagery Training for Self-harm N/A
Terminated NCT00539188 - N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD Phase 2
Recruiting NCT00491478 - Repetitive Behavior Disorders in People With Severe Mental Retardation Phase 3
Terminated NCT02483572 - Treatment of Severe Destructive Behavior: FCT Versus Wait-List Control N/A
Completed NCT02985047 - Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide N/A
Recruiting NCT04463654 - Zero Self-Harm - a Mobile Phone Application to Reduce Non-suicidal Self-injury N/A
Completed NCT04244786 - Treating Self Injurious Behavior: A Novel Brain Stimulation Approach N/A
Not yet recruiting NCT02595164 - Common Decision Making Deficits in Suicidal Behaviors and Eating Disorders N/A
Completed NCT00401102 - Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury Phase 1
Recruiting NCT06110585 - Transcranial Magnetic Stimulation in Patients With Depression and Non-suicidal Self-injury N/A
Completed NCT05563324 - Genetics of Self-injurious Behaviour
Recruiting NCT04045600 - Refinements of Functional Communication Training N/A
Recruiting NCT00694668 - The (Cost-) Effectiveness of Mindfulness-training and Cognitive Behavioural Therapy in Adolescents and Young Adults With Deliberate Self Harm Phase 2/Phase 3
Recruiting NCT05796531 - Therapeutic Evaluative Conditioning to Reduce Adolescents' Self-injurious Thoughts and Behaviors During and After Psychiatric Inpatient Hospitalization N/A
Terminated NCT01823120 - Text Message Intervention to Reduce Repeat Self-harm N/A
Recruiting NCT00169884 - The Efficacy of a Cognitive-Behavioural Intervention in Deliberate Self-Harm Patients Phase 2
Terminated NCT03980366 - Use of Electroconvulsive Therapy to Treat Self-Injurious Behavior in Adults With Autism Spectrum Disorders N/A
Not yet recruiting NCT05969080 - Self-Injury Treatment and Recovery in Veterans N/A
Recruiting NCT06225661 - Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour N/A
Enrolling by invitation NCT03995966 - A Clinical Trial for Self-Injurious Behavior N/A