search
Back to results

TEENS Multi-site Trial

Primary Purpose

Self-Injurious Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Emotion Regulation Individual Therapy for Adolescents (ERITA)
Treatment as usual
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-Injurious Behavior focused on measuring Internet-based intervention, Online therapy, Emotion regulation, ERITA

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Child and Adolescent Mental Health Services
  • Team for Self-injury, Child and Adolescent Mental Health Services, B195Recruiting
  • Child and Adolescent Mental Health Services Southern Region DenmarkRecruiting
  • Child and Adolescent Mental Health Services in Region Zealand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ERITA + TAU (Treatment as usual)

TAU (Treatment as usual)

Arm Description

The Emotion Regulation Individual Therapy for Adolescents (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

Within mental health services in Denmark child and adolescent psychiatrists provide specialized treatment for young psychiatric patients as outpatient services. In this study the control intervention (TAU) consists of clinical assessment and treatment for patient's current primary psychiatric condition (referral condition and A-diagnosis).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Non-suicidal self-injury as dichotomous (any/none)
The proportion of participants with any NSSI during the past four weeks.

Full Information

First Posted
December 2, 2021
Last Updated
March 14, 2023
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research, Region of Southern Denmark, Region Zealand
search

1. Study Identification

Unique Protocol Identification Number
NCT05179655
Brief Title
TEENS Multi-site Trial
Official Title
TEENS Multi-site Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research, Region of Southern Denmark, Region Zealand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Injurious Behavior
Keywords
Internet-based intervention, Online therapy, Emotion regulation, ERITA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An investigator-initiated, multi-site randomised, parallel group, clinical superiority trial with blinded outcome assessment investigating the internet-based intervention ERITA as add-on to TAU compared to TAU alone in NSSI engaging psychiatric, outpatient youth. Participants will be randomised at the allocation ratio 1:1. Randomisation will be handled centrally at the Copenhagen Trial Unit (CTU) using a computer-generated allocation sequence with a varying block size concealed from the investigators. The allocation sequence will be stratified NSSI at baseline 1-10 versus 11≤ episodes in the past month, and trial site. CTU will generate the allocation sequence and investigators at the clinical trial sites will assign participants to the intervention groups using an OpenClinica web-based system developed by the CTU
Masking
InvestigatorOutcomes Assessor
Masking Description
Due to the nature of the intervention, a blinding of participants and therapists is not possible. Blinded outcome assessment will be performed by a trained researcher. Statistical analyses will be performed by two blinded statisticians presenting independent reports and with the intervention groups coded as A and B.
Allocation
Randomized
Enrollment
356 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ERITA + TAU (Treatment as usual)
Arm Type
Experimental
Arm Description
The Emotion Regulation Individual Therapy for Adolescents (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
Arm Title
TAU (Treatment as usual)
Arm Type
Other
Arm Description
Within mental health services in Denmark child and adolescent psychiatrists provide specialized treatment for young psychiatric patients as outpatient services. In this study the control intervention (TAU) consists of clinical assessment and treatment for patient's current primary psychiatric condition (referral condition and A-diagnosis).
Intervention Type
Behavioral
Intervention Name(s)
Emotion Regulation Individual Therapy for Adolescents (ERITA)
Other Intervention Name(s)
ERITA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
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 Outcome Measure Information:
Title
Non-suicidal self-injury episodes
Description
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 Outcome Measure Information:
Title
Kidscreen-10; Quality of life
Description
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
Title
Symptoms of depression, anxiety and stress
Description
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
Title
Non-suicidal self-injury as dichotomous (any/none)
Description
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 Pre-specified Outcome Measures:
Title
Difficulties in emotion regulation
Description
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
Title
Borderline Symptom List (BSL-supplement).
Description
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)
Title
Suicidal ideations
Description
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)
Title
Coping with Children's Negative Emotions - Adolescents
Description
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
Title
Coping with Children's Negative Emotions - Parents
Description
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.
Time Frame
End of treatment after 12 weeks and 6 months follow-up
Title
Negative Effects Questionnaire
Description
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.
Time Frame
Through trial periode (every three weeks and end of treatment after 12 weeks)
Title
Working Alliance
Description
The alliance percieved between the participant and the therapist, WAI-SR
Time Frame
Through the trial period (week four and eight)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Britt Morthorst
Phone
0045 27521085
Email
britt.reuter.morthorst@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne K Pagsberg, Professor
Organizational Affiliation
Mental Health Services Capital Region Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Child and Adolescent Mental Health Services
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlene B Lauritsen, Professor
Phone
0045 97643317
Email
marlene.lauritsen@rn.dk
Facility Name
Team for Self-injury, Child and Adolescent Mental Health Services, B195
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lotte Rubæk, MHs
Phone
0045 38 64 10 98
Email
lotte.rubaek@regionh.dk
First Name & Middle Initial & Last Name & Degree
Ida L Jørgensen, MHs
Phone
0045 38 64 10 98
Email
ida.lichtenstein.joergensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Britt R Morthorst, PhD
Facility Name
Child and Adolescent Mental Health Services Southern Region Denmark
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rikke T. Wesselhoeft, Assprofessor
Phone
0045 22 35 85 90
Email
rwesselhoeft@health.sdu.dk
Facility Name
Child and Adolescent Mental Health Services in Region Zealand
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pia Jeppesen, Professor
Phone
0045 23969929
Email
pijep@regionsjaelland.dk

12. IPD Sharing Statement

Learn more about this trial

TEENS Multi-site Trial

We'll reach out to this number within 24 hrs