Self-Injurious Behavior Clinical Trial
Official title:
TEENS Multi-site Trial
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.
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. |
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 |
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 |
Denmark,
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 |
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