Trial document





This trial has been registered retrospectively.
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  DRKS00004949

Trial Description

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Title

Development of a screening procedure on the need for early pedeatric aids in early detection examaniation

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Trial Acronym

Early Aid 2

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Early prevention in Germany focuses on families with infants and small children under high stress that may potentially put the healthy development of their children at risk. The most important group coming into professional contact with young families are resident paediatricians. Yet, until now, there does not exist a validated instrument for pediatricians to assess the families´ need for psychosocial support.
In the first study phase (11/1/2011 to 12/31/2012) a paediatric instrument to assess psychosocial problems of families with young children was developed by using a web-based Delphi approach (N = 41). The paediatric instrument contains 13 items. The items are divided into two hierarchical groups. First, clinically relevant symptoms: regulation disorders on the side of the infant and postpartum depression on the side of the primary caregiver. Second, psychosocial problems in a narrower sense: problems concerning the infant (care, nutrition, development/behavior), problems of the primary caregiver (heavy exhaustion, lack of support), and problems in the parent-child interaction (e.g. deficient closeness, warmth).
In the second study phase (1/1/2013 to 12/31/2013) the instrument will be evaluated by comparing the assessments of resident paediatricians using the paediatric instrument with the assessments of trained interviewees undertaking a reference interview in the domestic environment of the participating families (n = 500).

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Brief Summary in Scientific Language

The aim of the present study is the development and evaluation of a time saving instrument for resident pediatricians to assess psychosocial problems of families with children aged 0-1 years. We used a web-based Delphi approach to reach consensus about the content of the instrument. A panel of 41 experts in the field of social paediatrics, child development and psychosocial risk factors evaluated the relevance and practicability of a set of 100 items in an iterative process. After reaching consensus about the items, an expert workshop (n = 21) was carried out to discuss the hierarchical structure and the design of the instrument. The paediatric instrument contains 13 items. The items are divided into two hierarchical groups. First, clinically relevant symptoms: regulation disorders on the side of the infant and postpartum depression on the side of the primary caregiver. Second, psychosocial problems in a narrower sense: problems concerning the infant (care, nutrition, development/behavior), problems of the primary caregiver (heavy exhaustion, lack of support), and problems in the parent-child interaction (e.g. deficient closeness, warmth).
Now in the second study phase (1/1/2013 to 12/31/2013) the paediatric instrument for the assessment of psychosocial support will be evaluated on the basis of the calculation of sensitivity and specificity indices. The assessments of resident paediatricians using the paediatric instrument are compared to the assessments of trained interviewees undertaking a reference interview in the domestic environment of the participating families (n = 500).

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Organizational Data

  •   DRKS00004949
  •   2013/08/15
  •   [---]*
  •   yes
  •   Approved
  •   102/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F43.2 -  Adjustment disorders
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Interventions/Observational Groups

  •   Resident paediatricians use the developed paediatric instrument to assess the need for psychosocial support of families with children in the first year of life (n = 500). Every family who is screened “positive” as well as a random draw (of the same size) of the “negative” screened families will be interviewed by trained interviewers in the domestic environment of the families. The concordance of the assessments of the resident pediatricians and the interviewers will be determined by calculating sensitivity and specificity indices.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Blinded
  •   assessor
  •   Other
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of a paediatric instrument to assess the need for psychosocial support of families with young children. The aim of the present study is to provide a time-saving instrument which helps padiatricians in private practice to identify the need for psychosocial support of families with young children and to provide them the support they need at an early stage.

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Secondary Outcome

Concordance of the assessments of resident paediatricians using the paediatric instrument are compared to the assessments of trained interviewees undertaking a reference interview in the domestic environment of the participating families (sensitivity and specificity)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/05/27
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Months
  •   6   Months
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Additional Inclusion Criteria

Sufficient German knowledge of the parents

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Exclusion Criteria

Severe psychiatric disorder of the parents

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Addresses

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    • UNIVERSITAETSKLINIKUM FREIBURG Klinik I für Allg. Pädiatrie Zentrum für Kinder- und Jugendmedizin
    • Mr.  Dr. Dipl. Psych.  Michael  Barth 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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    • Lehrstuhl für Sozialpädiatrie, TU München
    • Mr.  Prof. Dr.  Volker  Mall 
    • Heiglhofstr. 63
    • 81377  München
    • Germany
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    • UNIVERSITAETSKLINIKUM FREIBURG Klinik I für Allg. Pädiatrie Zentrum für Kinder- und Jugendmedizin
    • Mr.  Dipl. Psych.  Florian  Belzer 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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    • UNIVERSITAETSKLINIKUM FREIBURG Klinik I für Allg. Pädiatrie Zentrum für Kinder- und Jugendmedizin
    • Mr.  Dipl. Psych.  Florian  Belzer 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Nationales Zentrum Frühe Hilfen (NZFH) in der Bundeszentrale für gesundheitliche Aufklärung
    • Ostmerheimer Straße 220
    • 51109  Köln
    • Germany
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Status

  •   Recruiting ongoing
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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.