TEENS Multi-site Trial

ConditionSelf-Injurious Behavior

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age13-17

SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

356 Participants

are divided into 2 treatment groups

Group A: ERITA + TAU (Treatment as usual)Experimental treatment 2 interventions

Group B: TAU (Treatment as usual)Other 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

End of treatment after 12 weeks and 6 months follow-up

Secondary outcomes

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.

Time frame

End of treatment after 12 weeks and 6 months follow-up

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.

Time frame

End of treatment after 12 weeks and 6 months follow-up

Non-suicidal self-injury as dichotomous (any/none)

The proportion of participants with any NSSI during the past four weeks.

Time frame

End of treatment after 12 weeks and 6 months follow-up

Other outcomes

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.

Time frame

End of treatment after 12 weeks and 6 months follow-up

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.

Time frame

Through trial periode (every three weeks, end of treatment after 12 weeks and 6 months follow-up)

Suicidal ideations

Suicidal ideations assessed by SIDAS. A five item scale with questions ranging from 0 to 10. Final sum score from 0-50.

Time frame

Through trial period (every three weeks, end of treatment after 12 weeks and 6 months follow-up)

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.

Time frame

End of treatment after 12 weeks and 6 months follow-up