Trial document





This trial has been registered retrospectively.
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  DRKS00003356

Trial Description

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Title

Psychoanalytic Treatment with ADHD and ODD children - Frankfurt ADHD and ODD Effectiveness Study

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Trial Acronym

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URL of the Trial

http://www.sfi-frankfurt.de/de/forschung/forschungsfeld-1/therapiewirksamkeitsstudie.html

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Brief Summary in Lay Language

Although research has been conducted in the pharmacological and behavioural treatment of attention deficit/ hyperactivity disorder (ADHD) over the past decade, the empirical evidence for the differential effectiveness of psychoanalytic treatment has not yet been sufficiently studied. Between 2003 and 2006 the Sigmund-Freud-Institute, in cooperation with the Institute for Psychoanalytic Treatments of Children and Adolescents, conducted the Frankfurt Prevention Study (FPS). The FPS demonstrated that a two-year psychoanalytic (non-psychopharmacological) prevention and intervention program in Kindergarten resulted in a statistically significant decrease in ADHD symptoms, such as aggressive and impulsive behavior (Leuzinger-Bohleber et al. 2006, 2006a, 2007, Staufenberg 2011).
Recognizing the FPS-indicated benefits of psychoanalytic treatment for ADHD children, and the opportunity to deepen established research in collaboration with child analysts in Frankfurt, the Frankfurt ADHD and ODD Effectiveness Study was initiated in 2006.

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Brief Summary in Scientific Language

The effectiveness of long-term psychoanalytic treatment in children with ADHD or ODD children was investigated using a prospective, controlled design. The children, meeting the ICD-10 criteria for ADHD or ODD, were allocated, according to their first contact, to the intervention group (psychoanalytic treatment) or to one of the control groups (a. behavioral/medical treatment, b. treatment as usual, c. untreated control group). This means that if parents first consulted a psychoanalyst or the psychoanalytic outpatient clinic, the child was assigned to the psychoanalytic treatment group.

Psychoanalytic treatment: In accordance with the manual for psychoanalytic treatment (Staufenberg, 2011), psychoanalytic treatment was conducted by a psychoanalyst in private practice. Usually, children in psychoanalytic treatment saw the therapist twice a week, for 2 years on average. Parents saw the therapist once in two weeks.

Control group a) behavioral/medical treatment: Children within the behavioral/medical treatment group attended either a six-week attention and concentration training program (Marburger Konzentrationstraining, Krowatschek, Albrecht & Kowatschek, 1990, 2004) meeting once a week for two hours, accompanied by a parent training program, or they attended a two-week anti-aggression training program that took place in the hospital, daily from 8 AM to 7 PM (Anti-Aggression training, Grasmann & Stadler, 2008). At the beginning, children in the behavioral/medical treatment group were examined and diagnosed by a psychiatrist and medicated accordingly, if needed.

Control group b) Treatment As Usual (TAU): This treatment refers to a low-frequency child psychiatric treatment that includes parent counseling and optional medication, ergotherapy, social training and parents’ management-training.

Control group c) untreated control group: The untreated control group was selected from the untreated control group of the Frankfurt Prevention study.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003356
  •   2012/01/19
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  •   yes
  •   Approved
  •   [---]*, Ethikkommission - Landeskammer für Psychologische Psychotherapeutinnen und -therapeuten und Kinder- und Jugendlichenpsychotherapeutinnen und -therapeuten Hessen (LPPKJP Hessen), Gutenbergplatz 1, 65187 Wiesbaden
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Secondary IDs

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Health Condition or Problem studied

  •   F90.1 -  Hyperkinetic conduct disorder
  •   F91.3 -  Oppositional defiant disorder
  •   F90.0 -  Disturbance of activity and attention
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Interventions/Observational Groups

  •   psychoanalytic longterm treatment (no medication)
  •   behavioral therapy /medical treatment
  •   treatment as usual (psychiatric treatment)
  •   untreated controll group
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Diagnostic System for Mental Disorders in Children and Adolescents (DISYPS-KP, Döpfner & Lehmkuhl, 2003). The DISYPS-KP – Diagnostic System for mental Disorders in Children and Adolescents – consists of different types of data: a parental questionnaire (that can be used as a structured parent interview), a teacher questionnaire and a self-reporting questionnaire (for children aged 11-18). The clinical assessment is performed by clinicians and psychological professionals using the DISYPS-KP checklists for ADHD and ODD which are related to the stipulated in DSM-IV and ICD-10.
Three measurement thresholds: pre-measurement, post-measurement and follow-up measurement, one year after finishing treatment.

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Secondary Outcome

Conners Teacher Rating Scale. The Conners Teacher Rating Scale (CTRS-S) (Conners, 2001) includes four subscales: Hyperactivity, Attention Deficit, Conduct-Problem, and ADHD-Index. The CTRS-S has been found to be sensitive to changes in children with ADHD before and after (medical) treatment in the general school-age population (e.g., Pearson et al., 2003).
Conners Parent Rating Scale. The Conners Parent Rating Scale (CPRS-S) (Conners, 2001) includes four subscales: Hyperactivity, Attention Deficit, Conduct-Problem, ADHD-Index. The CTRS-S has been found to be sensitive to changes in children with ADHD before and after (medical) treatment in the general school-age population (e.g., Pearson et al., 2003).


Children were examined by use of different questionnaires and psychological tests. Intelligence was assessed using the Culture Fair Test, CFT-20R (Weiß, 2008). The child’s behavior during examination was reported by the observation questionnaire “behavior during examination” (VWU, Döpfner, Schurmann & Frölich 1998). Using the “d2 Test of attention” (Brickenkamp & Zillmer, 1998), we obtained a consistent and valid measure of visual scanning accuracy and speed. Furthermore, we applied the projective “Schweinchen-Schwarzfuss Test” as a psychoanalytically proven instrument for children. This narrative story stem test, including 17 cards with black and white drawings, features a little pig with a black foot as the main character (Corman, 1995). The test was tape recorded and transcribed, permitting the researchers to consider the inner psychic states and fantasies of the child.
Moreover, the Inventory for the Assessment of the Quality of Life in Children and Adolescents, ILK (Mattejat, 2006) was completed by children as well as by parents and therapists. The ILK addresses seven different areas of life such as school, family and friendship, and provides the opportunity to compare the different perspectives.
Regarding the assessment of children with ADHD and ODD, comorbidity is an important issue (e.g. Biederman et al., 2010, Germano et al., 2010). In order to further assess the children’s comorbidity, parents and teachers were requested to complete the Child Behavior Checklist and the Teacher Report Form, respectively (Achenbach, 1991, Arbeitsgruppe Deutsche Child Behavior Checklist 1998).
Primary data included a questionnaire of behavior that provides information about the first years of life, personal disease history, and family history (Englert, Jungmann, Lam, Wienand & Poustka, 1998).

Three measurement thresholds: pre-measurement, post-measurement and follow-up measurement, one year after finishing treatment.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2007/07/02
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

disturbens of activity and attention, hyperkinetic conduct disorder, conduct disorders

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Exclusion Criteria

schizophrenia, psychosis, developmental disorder

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Addresses

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    • Sigmund-Freud-Institut
    • Ms.  Prof. Dr.  Marianne  Leuzinger-Bohleber 
    • Myliusstraße 20
    • D-60323  Frankfurt am Main
    • Germany
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    • Sigmund-Freud-Institut
    • Ms.  PD Dr.  Katrin Luise  Läzer 
    • Myliusstr. 20
    • D-60323  Frankfurt am Main
    • Germany
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    • Sigmund-Freud-Institut
    • Ms.  PD Dr.  Katrin Luise  Läzer 
    • Myliusstr. 20
    • D-60323  Frankfurt am Main
    • Germany
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Sources of Monetary or Material Support

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    • VAKJP - Vereinigung Analytischer Kinder- und Jugendlichenpsychotherapeuten in Deutschland e.V. gegr. 1953.
    • 70190  Stuttgart
    • Germany
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    • Hessisches Ministerium für Wissenschaft und Kunst (HMWK)
    • Rheinstraße 23 - 25
    • 65185  Wiesbaden
    • Germany
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    • Zinkann-Stiftung
    • 33617  Bielefeld
    • Germany
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    • Sigmund-Freud-Institut Frankfurt. Forschungsinstitut für Psychoanalyse und ihre Anwendungen
    • c/o J.W. Goethe-Universität Frankfurt am Main Mertonstr. 17/ Hauspostfach 55
    • D-60325  Frankfurt am Main
    • Germany
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    • Institut für analytische Kinder- und Jugendlichenpsychotherapie in Hessen e.V.
    • D-60325  Frankfurt am Main
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/30
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Trial Publications, Results and other Documents

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