Trial document




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  DRKS00017586

Trial Description

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Title

Evaluation of a standardized outpatient emergency management for adolescents with non-suicidal self-harming behaviors and suicidal behavior

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

By participating in the trial, the adolescents and their parents play a key role in assessing how effective our emergency management is. This will allow us to develop new approaches and ideas for the care of adolescents who are in a similar situation as they are.
The study starts like the normal emergency procedure as follows:
The teenagers present themselves and their parents to the emergency room.
There we will try to help them quickly. Further appointments include diagnostic and advice (safety plan, recommendations, etc.).
If they are interested in the study and the participation is approved after detailed information, the adolescents and their parents will receive two more appointments, which should take place approximately 4 and 8 weeks after the last regular appointment.
Interviews and questionnaires are used to check to what extent the appointments which have taken place so far helped, how the adolescents and their families came to terms with the safety plan and recommendations, and how we can improve the process in our emergency room.

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Brief Summary in Scientific Language

The study is a catamnestic trial with two consecutively follow-up examinations to prove whether the existing standardized emergency management in the outpatient department of Child and Adolescent Psychiatry is effective.
The standardized emergency management in the outpatient department of child and adolescent psychiatry includes diagnostics tailored to adolescents with non-suicidal self-harming behavior and suicidal behavior combined with short-term intervention and recommendations for further counseling and treatment. The follow - up examinations are used to assess the course of the psychopathology of the affected persons and to evaluate whether the counseling situation or emergency management has had a positive effect on the affected families / patients. In particular, it should be examined whether the recommendations given for follow-up were implemented. As part of the follow-up with the help of clinical interviews and questionnaires application experiences should be systematically evaluated. The trial examines the consecutive occupancy population of emergency situations of adolescents in the outpatient department.
The two follow-up examinations should be carried out on at least 70 patients / volunteers. We estimate a drop-out rate of about 20-30% with an initial sample of 100 adolescents who have gone through the outpatient's standardized emergency management.

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Organizational Data

  •   DRKS00017586
  •   2019/08/13
  •   [---]*
  •   yes
  •   Approved
  •   19-1426-101, Ethikkommission an der Universität Regensburg
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Secondary IDs

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Health Condition or Problem studied

  •   non-suicidal self-harming behaviour
  •   X84 -  Intentional self-harm by unspecified means
  •   suicidal behaviour
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Interventions/Observational Groups

  •   Two follow-up appointments after 4-6 and 8-10 weeks after completion of the standardized emergency management to evaluate the effectiveness.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1. Optimization of the existing emergency management with the help of the information gained through the catamnesis.
2. Reduction of self-harming during the course by targeted indication and by use of a safety plan.
The endpoint is recorded when 70 study participants are enrolled.

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Secondary Outcome

Survey of general functional level and severity of mental illness:
• GAF - Global assesment of functioning (Endicott et al., 1976)
• CGI-S - Clinical global Impressions - Disease severity (Busner and Targum, 2007)

Dimensional psychiatric diagnosis for follow-up with regard to general psychopathology and self-harming as well as suicidal behavior:
- SCL-90-S: This is a self-assessment method used worldwide to record mental stress in patients ("SCL-90®-S - Symptom Checklist 90® Standard - Hogrefe, Psychology Publishing," n.d.)
- SITBI - Follow-Up: The Self-Injurious Thoughts and Behaviors Interview (Nock et al., 2007) is a structured interview broken down into six modules, within the presence, frequency, and characteristics of six types of self-harming thoughts and behaviors are recorded ("Diagnosis of Suicidality - Hogrefe, Psychology," n.d.).
It is also used for a problem analysis for the causal research and as a basis for the following recommendations. This is a appropriate diagnostic tool for clinics and research (Fischer et al., 2014). This examines the course of suicidal and non-suicidal self-harming behavior.
- ERS: Emotion Reactivity Scale: This examines the emotional reactivity of adolescents; this is also related to psychopathology and self-harming thoughts or behavior (Nock et al., 2008)
- Questions about the motivation of young people to end self-harming behavior, from the study by Armitage et al. (Armitage et al., 2016). This is to determine whether the motivation of the adolescents has changed.
- Questions about the benefits of the safety plan and the implementation of the recommendations
 
With the guardians / caregivers:
• SITBI follow-up: problem analysis with the guardian
• Questions about the benefits of the safety plan and the implementation of the recommendations
• Parent Motivation Inventory: This instrument is used to measure the motivation of the guardians to participate in a treatment (Nock and Photos, 2006), as well as to check whether the motivation of the guardians has changed.

The endpoint is recorded when 70 study participants are enrolled.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/08/15
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   11   Years
  •   19   Years
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Additional Inclusion Criteria

• Sufficient understanding of the German language
• Informed consent of the study participant and their legal guardians
• Patients who are presented as emergency in the clinical outpatient department with suicidal behavior and / or self-harming behavior
• Age at the start of the study: 11-19 years

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Exclusion Criteria

• Acute psychotic disorder or other acute psychiatric condition that may affect the patient's capacity to consent
• Intellectual disability (IQ <80) according to clinical assessment
• Acute suicidality requiring longer stationary treatment (more than 4 nights) at one of the medical wards
• regular outpatient treatment by established child and adolescent psychiatric colleagues, which does not require a specified treatment
• Lack of consent

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Addresses

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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg
    • Mr.  Prof. Dr. med  Romuald  Brunner 
    • Universitätsstr. 84
    • 93053  Regensburg
    • Germany
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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg
    • Mr.  Prof. Dr. med  Romuald  Brunner 
    • Universitätsstr. 84
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address scientific-contact
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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg
    • Mr.  Prof. Dr. med  Romuald  Brunner 
    • Universitätsstr. 84
    • 93053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg
    • Mr.  Prof. Dr. med  Romuald  Brunner 
    • Universitätsstr. 84
    • 93053  Regensburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.