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NCT Number: NCT05179655

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.

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Key information

Conditions

Self-Injurious Behavior Behavior Behavioral Symptoms Emotional Regulation Self-Control Social Behavior

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Team for Self-injury, Child and Adolescent Mental Health Services, B195, Copenhagen, Ø, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ERITA

Treatment as Usual

Other

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.

Primary outcomes

  1. Non-suicidal self-injury episodes

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

    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

Secondary outcomes

  1. Kidscreen-10; Quality of life

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

    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.

  2. Symptoms of depression, anxiety and stress

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

    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.

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

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

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

Other outcomes

  1. Difficulties in emotion regulation

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

    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.

  2. Borderline Symptom List (BSL-supplement).

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

    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.

  3. Suicidal ideations

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

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

  4. Coping with Children's Negative Emotions - Adolescents

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

    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.

  5. Coping with Children's Negative Emotions - Parents

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

    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.

  6. Negative Effects Questionnaire

    Time frame: Through trial periode (every three weeks and end of treatment after 12 weeks)

    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.

  7. Working Alliance

    Time frame: Through the trial period (week four and eight)

    The alliance percieved between the participant and the therapist, WAI-SR

Study contacts

Contact information is provided by the study sponsor or research team.

Britt Morthorst

CONTACT

[email protected]

0045 27521085

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Region Zealand
  • Region of Southern Denmark

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2022
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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