Trial document

This trial has been registered retrospectively.
drksid header


Trial Description

start of 1:1-Block title


Intervention study of school refusing students and truants in Essen

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

Trial Acronym


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

About 5-10% of all German children and youths fail to appear in school regularly. So far, there is only few scientific knowledge what can be done to help these students to participate regularly in class. Hence, we have developped a multiprofessional treatment concept (for school-refusing or school-truant children and youths suffering from mental illnesses) whose efficacy is going to be evaluated in comparison to traditional treatment concepts.

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

Brief Summary in Scientific Language

About 5-10% of all German children and youths fail to appear in school regularly (Jans & Warnke, 2004; Schreiber-Kittl & Schröpfer, 2002; Wagner, Dunkake, & Weiß, 2004). If regular school absentism and mental disorders occur together , Knollmann et al. (2010) talk about school avoiding behavior. According to literature, the possible causes for school avoiding behavior must be differentiated. Truancy i.e. oppositional, delinquent behavior as well as anxiety or phobia can cause school absenteeism. School refusal that is related to anxiety disorders can be distinguished into two different types: “School anxiety” refers to exam nerves, social anxiety disorders and bullying ; secondly, “school phobia” describes the phenomenon of separation anxiety.
Whereas parents of school refusing students know that their children are absent from school and sometimes support their children’s school absenteeism, parents of truants are initially not informed about their child’s behavior.
Kearney (2007) states four different functions that school avoiding behavior, i.e. school refusal and truancy, can satisfy:
• Attention-seeking behavior/Separation anxiety
• Avoidance of stimuli that provoke a general sense of negative affectivity
• Positive tangible reinforcement
• Escape from aversive and evaluative situations
Most clinical intervention studies focus on the treatment of (anxiety-based) school refusing students (Heyne et al., 2002; Ohmann et al., 2007). The results indicate that a combination of behavior therapy with medication is a successful treatment (e.g. Bernstein et al., 2001). Regular consultations with teachers are integrated in some studies’ treatment concept (Last, Hansen & Falco, 1998; Heyne et al., 2002). Nevertheless some of these intervention studies show a lack of appropriate methods, e.g. missing randomization (Blagg & Yule, 1984) or no control group (Ohmann et al., 2007).
Combined treatment approaches integrating cognitive strategies as well as behavioral strategies, family therapy, social skill training and regular consultations with school staff into one treatment concept are still seldom to be found; sometimes results of such combined approaches are not persuasive (Kearney, 2008, S. 463; Heyne et al, 2002).
Heyne et al. (2002) treated 7 to 14 year old school refusing students either by an isolated child therapy or by an isolated parent training (including consultations with teachers) or by a combined child therapy with a parent training. Contrary to expectations, the combined intervention did not prove to be more effective than an isolated parent training. Both parental interventions revealed better results than the isolated child therapy. However follow-up-data showed no significant differences between the three groups. Thus it seems that the indication for an isolated or a combined treatment approach is crucial (Heyne, 2002).
Behavioral therapy is one component of a multi-professional treatment: According to Blagg and Yule (1984), behavioral therapy was more successful than inpatient treatment or homeschooling plus general psychotherapy. Probably because of lack of randomization, inpatients were more severely impaired than ambulant patients so that despite of multi-professional treatment impatient treatment resulted less often in school reintegration than ambulant therapy.
In our study the success of a combined treatment approach will be evaluated: Is an out-patient, combined multiprofessional and motivational treatment including cognitive behavioral therapy, family- and school counselling as well as the possibility taking part in a coached sports course more effective than an uni-professional treatment as ususal in the regular treatment system?

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

Organizational Data

  •   DRKS00000738
  •   2011/09/28
  •   [---]*
  •   yes
  •   Approved
  •   11-4606, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1120-4332 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Schoolrefusing and schooltruant youth with mental disorders
  •   F99 -  Mental disorder, not otherwise specified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   MBT: Ambulant therapy according to manual
    • School refusing student and psychological parent participate in two diagnostic sessions (screening & pretest).
    • School refusing student and psychological parent participate in four individual sessions à 60 minutes as preparation for 12 subsequent group sessions (in combination with optional individual sessions every two weeks).
    • Parents can participate in a parent training during 9 weeks.
    Total time: minimum 16 weeks. It’s possible to continue with group sessions after 16 weeks. A first evaluation of treatment success is going to be evaluated in week 9 (inter): If at this moment the patient is highly affected by his disorder according to a standardized rating (ICD-10, 6th axis), the patient will be assigned to inpatient treatment. The preparation for inpatient treatment as well as out-patient aftercare will occur manual-based.
    • Indications of assignment to inpatient treatment:
    The therapy team judges according to their rating (ICD-10, 6th axis) if an assignment to inpatient treatment is required: The 6th axis of ICD-10 describes the patient’s psychosocial functioning. If according to the therapy team’s rating, the patient’s functioning scores at least 6, the therapy team assigns him to inpatient treatment.
  •   TAU: Treatment as usual
    • After randomization patients get a standardized recommendation to ambulant therapy or to inpatient therapy if necessary. Patients themselves will decide if they accept our recommendation and get treatment according to it.
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Percentage of attended school lessons within the five school days before the initial interview, after 16 weeks (post), after 26 (follow-up 1) and after 52 weeks (follow-up 2), each with teachers’ and parents’ information. For data analysis teachers’ information are favored. If teachers’ information are not available, parents’ information are used. The data are surveyed using the SV-outcome-questionnaire.

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

Secondary Outcome

Secondary outcome: Percentage of school weeks during which school lessons were attended regularly within the last 25 weeks before the initial interview, before the first (after 26 weeks) and the second follow-up measurement (after 52 weeks) (teachers’ and parents’ information). A regularly attended school week is defined as school week with no more than 60 minutes absence from school (this corresponds a 95% quota of attendance).

Tertiary outcome:
Tertiary outcome variables are mental well-being (Child Behavior Checklist - CBCL, Teacher's Report Form -TRF, Symtom-Checklist 90-Revised - SCL 90-R (during the phone interview are only the scales for anxiety and depression surveyed, KINDL - questionnaire for assessment of health-related well-being), general self-efficacy or rather self-efficacy concerning school situations (questionnnaire of general self-efficacy - WIRKALL), patients’ functioning (Global Assessment of Functioning -GAF) as well as parents’ well-being (SCL 90-R) and parents’ self-efficacy (WIRKALL).

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

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   Actual
  •   2011/03/01
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

• Students avoiding school, i.e. students avoiding school regularly and at least for a few lessons.
• Age: 6 to inclusively 20
• Child/youth must be fluent in German so that participation in therapy is possible.
• Adequate reading and writing skills
• Informed consent to participation in study of parents or person holding the right of child custody
• Child’s completion of screening- and pretests
• Consent to release confidential or privileged information to the current class teacher and in case of changing class or school towards his replacement
• Diagnosed mental disorder (according to ICD-10)
• Exclusion of major or severe illness concerning the cardio-pulmonary, abdominal, nervous or locomotor system

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

Exclusion Criteria

• IQ < 70 (as measured by CFT 20-R)
• Physically handicapped students and /or students with a severe physical disease (e.g. cardiac insufficiency, tumor)
• Lack of a diagnosis of a mental disorder (according to ICD-10)
• Students with a diagnosed mental disorder such as Schizophrenia and delusional disorders or other F2-Diagnosis from ICD 10 or acute risk-to-self or risk-to-others
• Students avoiding school only by displaying little interest for school and by not participating in lessons
• Students regularly arriving too late to lessons but without absence for at least one lesson
• Students who are kept away from school by their parents (e.g. because of concealing abuse or because of financial advantages)
• Students that are not allowed to attend school because of school penalty
• Students currently undergoing a regular psychotherapy which also focuses school avoiding behavior

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


  • start of 1:1-Block address primary-sponsor
    • LVR-Klinikum Essen d. Universität Duisburg-Essen Klinik f. Psychiatrie u. Psychotherapie des Kindes- und Jugendalters
    • Mr.  Prof. Dr. med.  Johannes   Hebebrand 
    • Virchowstr. 174
    • 45147  Essen
    • 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 scientific-contact
    • LVR-Klinikum Essen d. Universität Duisburg-Essen Klinik f. Psychiatrie u. Psychotherapie des Kindes- und Jugendalters
    • Mr.  Dr. med.  Volker  Reissner 
    • Virchowstr. 174
    • 45147  Essen
    • 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
    • LVR-Klinikum Essen d. Universität Duisburg-Essen Klinik f. Psychiatrie u. Psychotherapie des Kindes- und Jugendalters
    • Mr.  Dr. med.  Volker  Reissner 
    • Virchowstr. 174
    • 45147  Essen
    • 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
    • Forschungszentrum Jülich Entwicklung, Technologie, Nachhaltigkeit (ETN)
    • Ms.  Dr.   Jutta  von Reis 
    • Karl-Heinz-Beckurts-Str. 13
    • 52428  Jülich
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   0049/ 2461/ 690-694
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting complete, follow-up complete
  •   2013/10/01
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.