Trial document




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  DRKS00003605

Trial Description

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Title

short term therapy in adolescents with self-destructive and risk-taking behaviours

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Trial Acronym

[---]*

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URL of the Trial

https://www.klinikum.uni-heidelberg.de/RCT-bei-NSSV.127255.0.html

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Brief Summary in Lay Language

Most current data from Heidelberg and the Rhein-Neckar-Kreis show, that more than 20% of all adolescents have already shown nonsuicidal self-injury (NSSI) during their life. 4% of all adolescents show this behavior even repeatedly (Brunner et al., 2007). Often this is leading to chronification and poses a severe threat to adolescent development. But only 10% of the adolescents, who often harm themselves, are introduced to professional establishments. Additionally, there is still a lack of specific and efficient treatment programs for this particular group of adolescents.

In this study, a new therapeutic program is to be compared with other, in the public helping system already existing, treatments. The new treatment concept is a manualised short-term therapy that especially includes elements of cognitive-behavioral therapy but also dialectic-behavioral therapy and was developed especially for adolescents. 70 adolescents aged between 12 and 17 years from Heidelberg and the Rhein-Neckar-Kreis, who harm themselves regularly in the past 6 months, are to be assigned to one of the both treatment concepts by lot. To test the effectiveness of the therapy, the adolescents shall achieve a broad diagnostic assessment at four points in time (before treatment , direct after treatment, 6 months after treatment and 24-48 months after baseline). The follow-up 2 was added in the context of an ethics amendment (S-363/2011, 16/06/2016) to investigate long-term effects of the therapy. Within the follow-up 2 we want to gather samples for genetic analyses. Therefore, we perform smears of the mouth mucosa to investigate polymorphisms that are assoicated with nonsuicidal self-injury. We want to investigate polymorphisms of three prominent receptors: dopamin, serotonin and oxytocin.
Main objective of the study is to investigate, if the new treatment causes a significant reduction in the frequency of NSSI in the therapy group compared to control group, ergo therapy in the existing helping system.

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Brief Summary in Scientific Language

Current data from Heidelberg and the Rhein-Neckar-Kreis show, that more than 20% of all adolescents have already shown nonsuicidal self-injury (NSSI). 4% of all adolescents show this behavior even repeatedly (Brunner et al., 2007), which often leads to a chronification and poses a severe threat to the development of the adolescents. Even repetitive forms of NSSI only infrequently (10%) lead to introductions of adolescents in professional healthcare by their parents. Additionally, there is still a lack of evidence-based, specific, and effective manualised treatment approaches for this particular group. The existing new treatment manual – the Cutting Down-Programme by Taylor et al. (2011) –whose development based on MACT (Evans et al.,1999) and which was especially adapted for adolescents, is to be applied for the first time in Germany and its effectiveness is to be tested the first time ever. Therefore, 70 adolescents aged between 12 and 17 from Heidelberg and the Rhein-Neckar-Kreis, who regularly have shown NSSI in the last 6 months, are to be involved in a randomized controlled therapy study. The adolescents shall achieve a broad diagnostic assessment by means of structured interviews and questionnaires at four measurement time points (before treatment, direct after treatment, 6 months after treatment and 24-48 months after baseline). The follow-up 2 was added in the context of an ethics amendment (S-363/2011, 16/06/2016) to investigate long-term effects of the therapy. Within the follow-up 2 we also gather samples for genetic analyses. Therefore, we perform smears of the mouth mucosa to investigate polymorphisms that are assoicated with nonsuicidal self-injury. We want to investigate polymorphisms of three prominent receptors: dopamin, serotonin and oxytocin.
Main objective is to test, if a significant reduction (or rather a remission) in the frequency of NSSI can be reached in the therapy group compared to a control group, which achieves “Treatment as Usual” (TAU). Secondary, an amelioration of well-being and self-worth as well as a reduction of depressiveness shall also be aims of the existing study.
To examine the causes and conditions of this clinical picture, which is not studied very broadly yet, it shall be tested, if the existence of comorbid emotional disturbances or wearing childhood memories can be regarded as prognostic factors for the course and the response to therapy.

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Organizational Data

  •   DRKS00003605
  •   2012/07/10
  •   [---]*
  •   yes
  •   Approved
  •   S-363/2011, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1130-1097 
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Health Condition or Problem studied

  •   X84 -  Intentional self-harm by unspecified means
  •   R45.8 -  Other symptoms and signs involving emotional state
  •   F32 -  Depressive episode
  •   self-worth
  •   quality of life
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Interventions/Observational Groups

  •   The used short-term treatment programm called “The Cutting Down-Program” is a manualised short-term therapy, which is designed for 8 to 12 therapy sessions. It includes elements of the cognitive-behavioral therapy but also elements of the dialectic-behavioral therapy. The program comprises four main modules, which can be individually expanded by optional modules – according to requirements of the patient. The four main modules are about the creation of therapy motivation and compliance of the subjects, the identification of reasons for the existing behavior, the testing of alternative behaviors instead of nonsuicidal self-injury and the stabilization of alternative behaviors to reduce aversive strains, which often activate nonsuicidal self-injury. In addition to individual therapy sessions, the subjects have to do some homework with regard to preparation and post- processing of the therapy sessions, to increase their effectiveness.
  •   After the diagnostic assessment is finished, the adolescents are advised of their allocation to the control group by phone. During this telephone call, they will be assured over again to do a therapy and then they are referred to the existing health care system by giving them contact details of established child psychotherapists, psychiatrists, clinics or advice centers. The concerned establishments are informed beforehand about the study and they are asked to take part in the study. This fact shall ensure a near-term introduction and a fast therapy offer.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Main outcome is the significant reduction of the frequency of nonsuicidal self-injury in the group of subjects, who receive the treatment programme compared to the group, which receives TAU. The reduction shall be measured with the Self-Injurous Thoughts and Behaviors Interview-German (SITBI-G) at the Baseline (before therapy), the Postline (directly after therapy), the Follow- Up (6 month after therapy) and the Follow-Up 2 (24-48 months after baseline).

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Secondary Outcome

Other goal criteria are to be the amelioration of well-being in the KIDSCREEN and self-worth in the Self-esteem Scale (SES) by Rosenberg as well as the reduction of depressiveness in Beck Depression Inventory (BDI- II). It shall also be examined, if the existence of a comorbid emotional disturbance, which can be diagnosed by means of the Structured Clinical Interview for DSM-IV (SKID-II) and the Mini-International Neuropsychiatric Interview-Kid (M.I.N.I.-Kid), or traumatic childhood experiences, which can be acquired by the Childhood Experience of Care and Abuse (CECA) Interview, are of use as prognostic factors. Furthermore, with the Questionnaire of patient contentedness (ZUF), it shall be examined, if the subject was content with the therapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/09/17
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   17   Years
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Additional Inclusion Criteria

Subjects aged between 12 and 17, who name nonsuicidal self-injury in terms of snags and burn injuries and similar injuries in at least 5 cases in the last 6 months by means of a structured clinical interview, are to be recruited for the study. The last nonsuicidal self-injury should not date back longer than a month.

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Exclusion Criteria

Adolescents, who have acute psychotic symptoms as well as acute suicidal tendencies or other severe self-endangerment, which require an immediate intensive or stationary intervention, are not allowed to take part in the study. Also the existence of a mental retardation (IQ<80) is a criterion for exclusion. Also adolescents, who are already in a current therapy at the beginning of the study or who already finished a therapy, are excluded from the study.

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Addresses

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    • Klinik für Kinder- und Jugendpsychiatrie Psychosoziales Zentrum Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Romuald  Brunner 
    • Blumenstraße 8
    • 69115  Heidelberg
    • Germany
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    • Klinik für Kinder- und Jugendpsychiatrie Psychosoziales Zentrum Universitätsklinikum Heidelberg
    • Mr.  Dr.   Michael  Kaess 
    • Blumenstraße 8
    • 69115  Heidelberg
    • Germany
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    • Klinik für Kinder- und Jugendpsychiatrie Psychosoziales Zentrum Universitätsklinikum Heidelberg
    • Ms.  Dipl. Psych.  Gloria  Fischer 
    • Blumenstraße 8
    • 69115  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Kinder- und Jugendpsychiatrie am Psychosozialen Zentrum der Universität Heidelberg
    • Blumenstraße 8
    • 69115  Heidelberg
    • Germany
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    •   06221-566915
    •   06221-566941
    •   [---]*
    •   [---]*
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    • Dietmar Hopp Stiftung gGmbH
    • Raiffeisenstraße 51
    • 68789  St. Leon
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/02/01
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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.