TEENS Multi-site Trial

Self-Injurious Behavior Clinical Trial

Official title:

TEENS Multi-site Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179655
• Other study ID #: H-21035306
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Self-Injurious Behavior

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