Trial document




drksid header

  DRKS00012585

Trial Description

start of 1:1-Block title

Title

Evaluation of the PlaymoCase for the Use of the Operationalized Psychodynamic Diagnosis in Childhood and Adolescence (OPD-CA2)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PlaymoCase

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In order to recognize and treat mental illness, certain tools have to be developed. In the proposed study we will investigate whether the PlaymoCase can be such a tool. The PlaymoCase contains miniature plastic figures from different themes. It is sponsored and compiled by the Medical Academy for Psychotherapy of Children and Adolescents, e. V., Munich, which supports this study, and is used by psychotherapists.
Often, however, it is difficult to recognize relaibly criteria for mental illness. A possible established procedure can be carried out using the "Operationalized Psychodynamic Diagnostics in the Childhood and Adolescence" (OPD-CA2). Operationalized means that certain topics are examined with previously defined procedures, and that these procedures are reliable and repeatable from the respective investigator. Psychodynamically means that internal processes can be investigated, as the typically occur in psychological and psychoanalytic treatment.
In this study, we will investigate whether the PlaymoCase is capable of establishing a diagnosis for intrapsychic processes by applying the assessment system of the OPD-CA2. The areas of interdependence, internal conflicts and psychological structure are assessed. The OPD-CA2 describes these sub-areas, but whether a clinical diagnosis can be found depends on additional investigations.
Children aged 7 to 12 years are asked to play with the PlaymoCase. The session is videotaped and consecutively rated by two independent raters according to the OPD-CA2 criteria. The aim of the study is reached, when the axes of the OPD-CA2 can be assessed.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The Operationalized Psychodynamic Diagnostics in Childhood and Adolescence in the revised version (OPD-CA2) is an effective instrument for recognizing and describing psychodynamics in a structured, valid, objective and reliable manner. It is used for the diagnosis of mental disorders and is an important part of therapy planning in psychological and psychoanalytic therapies. In an interdisciplinary and methodological understanding, OPD-CA2 can also describe interactions between the patient and the therapist. The OPD-CA2 is based on a semi-structured interview, its findings are based on observation of play and behavior as well as therapeutic conversation and scenic understanding. It can describe the axes structure, conflict, relationship and treatment requirements.

In a play-therapeutic approach, the present study protocol aims at investigating whether a psychodynamic assessment based on the OPD-CA2 can be achieved by the use of a semi-standardized setting with specific therapeutic material. Here, plastic figures from the child-like world of play is to be used in a certain composition (PlaymoCase).

Therapy sessions of subjects and patients between 7 and 12 years will be recorded by a video camera, which is then evaluated by independent assessors and evaluated with regard to the axes of the OPD-CA2.
In addition, by means of an empirical-statistical analysis, differences between the subjects and patients with regard to gender, age and presentation of disorders are examined with regard to the frequency of the use of certain figures or figure groups and the theme of the play.

The present study protocol is a prospective observation study as a proof-of-principle of a psychodynamic diagnostic method.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012585
  •   2017/06/27
  •   [---]*
  •   yes
  •   Approved
  •   S-173/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1197-9369 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F90-F98 -  Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
  •   F20-F29 -  Schizophrenia, schizotypal and delusional disorders
  •   F30-F39 -  Mood [affective] disorders
  •   F40-F48 -  Neurotic, stress-related and somatoform disorders
  •   F50-F59 -  Behavioural syndromes associated with physiological disturbances and physical factors
  •   F70-F79 -  Mental retardation
  •   F80-F89 -  Disorders of psychological development
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   A psychotherapy session of 50 minutes duration is filmed by a video camera and recorded on a storage medium.
    Proband and therapist can make use of the PlaymoCase (Medical Academy for Psychotherapy of Children and Adolescents e. V., Munich, Germany, Type L, 2017). The video should give an overview of the room, but has to be detailed enough that individual figures of the PlaymoCase can be identified. In the room, only patient and therapist should be present to minimize disturbances and distractions by third parties.

    Two independent assessors rate the videographed material according to the OPD-CA2. The results are sent to the study center for evaluation. There, a total data record is prepared, on the basis of which the achievement or failure of the target criteria is assessed.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Is it possible to use the PlaymoCase for diagnostics according to the Operationalized Psychodynamic Diagnostics in Childhood and Adolescence, Revision (OPD-CA2) (Proof-of-Principle)? This question is to be answered by the result sheets derived from the videotaped material. The endpoint is reached when the axes of the OPD-CA2 can be filled out.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

a) Is it possible to evaluate the different axes of the OPD-CA2?
b) Are there statistically significant differences in the use of certain figures, or groups of figures, of themes of the play with regard to sex, age, and disorders of proband, or patient, respectively?

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/08/07
  •   52
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   7   Years
  •   11   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Informed consent for the participation in the study by the gare givers and the child.
• Age: 7;0-11;11 year.
• No mental disorder
or
mental or behavioral disorder according to ICD-10 from:
o F2 (Schizophrenia, schizotypal and delusional disorders),
o F3 (Mood [affective] disorders),
o F4 (Neurotic, stress-related and somatoform disorders),
o F5 (Behavioural syndromes associated with physiological disturbances and physical factors),
o F7 (Mental retardation),
o F8 (Disorders of psychological development) and
o F9 (Behavioural and emotional disorders with onset usually occurring in childhood and adolescence).

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• Age <=6;11 oder >=12;0 years.
• Mental or behavioral disorder according to ICD-10 from:
o F0 (Organic, including symptomatic, mental disorders),
o F1 (Mental and behavioural disorders due to psychoactive substance use),
o F6 (Disorders of adult personality and behaviour).
• Simultaneous treatment with medication of mental and behavioral disorders.
• Severe chronic somatic disorder.
• Mental and behavioral co-morbidity.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Ärztliche Akademie für Psychotherapie von Kindern und Jugendlichen e. V.
    • Mr.  Dr. med.  Manfred  Endres 
    • Spiegelstrasse 5
    • 81241  München
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Praxis für Kinder- und Jugendpsychotherapie
    • Ms.  Dipl.-Soz.  Dagmar  Lehmhaus 
    • Sirrenberg 3
    • 45549  Sprockhövel
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Praxis für Kinder- und Jugendpsychotherapie
    • Ms.  Dipl.-Päd.  Bertke  Reiffen-Züger 
    • Lieneschweg 101
    • 49076  Osnabrück
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Praxis für Kinder- und Jugendpsychotherapie
    • Ms.  Sybille  Moisl 
    • Spiegelstr. 5
    • 8124  München
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Praxis für Kinder und Jugendlichenpsychotherapie
    • Ms.  Dipl.-Soz. Päd. (FH)  Sabine  Prentl 
    • Max-Josefs-Platz 23
    • 83022  Rosenheim
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Praxis für Kinder- und Jugendpsychotherapie
    • Ms.  Iris  Rexroth 
    • Am Römling 14
    • 93047  Regensburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • c/o Ärztliche Akademie für Psychotherapie von Kindern und Jugendlichen e. V.
    • Mr.  Prof. Dr. med.  Martin  Maurer 
    • Spiegelstrasse 5
    • 81241  München
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Ärztliche Akademie für Psychotherapie von Kindern und Jugendlichen e. V.
    • Mr.  Prof. Dr. med.  Martin  Maurer 
    • Spiegelstr. 5
    • 81241  München
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Ärztliche Akademie für Psychotherapie von Kindern und Jugendlichen e. V.
    • Mr.  Dr. med.  Manfred  Endres 
    • Spiegelstrasse 5
    • 81241  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • c/o Ärztliche Akademie für Psychotherapie von Kindern und Jugendlichen e.V.
    • Mr.  Prof. Dr.  Martin  Maurer 
    • Spiegelstr. 5
    • 81241  München
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.