Trial document




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  DRKS00023281

Trial Description

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Title

CBASP@YoungAge - An individualized, modular therapy program for children and adolescents with depression and interpersonal problems

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Trial Acronym

CBASP@YoungAge

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URL of the Trial

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Brief Summary in Lay Language

The planned study is the first implementation of the CBASP@YoungAge therapy program, specifically developed for children, adolescents and their caregivers, which aims to treat depression in children and adolescents on an individualized basis. The therapy is based on the CBASP psychotherapy for chronic depression developed for adults (McCullough, 2003).
Thereby already proven techniques from CBASP are adapted for different young age groups. The Caregivers are directly involved in the therapy. The aim of the study is to assess the general feasibility and effectiveness of CBASP@YoungAge on the depressive symptoms of children and adolescents.

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Brief Summary in Scientific Language

Depressions are relevant diseases in childhood and adolescence. There is clear evidence that early onsets of depressive disorders can predict a more severe and chronic course in adulthood. In adults with chronic depression, the majority of depressions are characterized by a beginning in childhood or adolescence. It is therefore of high clinical relevance to detect and treat depression in childhood and adolescence at an early stage. CBASP is a therapy program for adults with chronic depressive disorders and shows good efficacy especially in persons who have experienced early childhood trauma (Nemeroff et al., 2003; Schramm et al., 2015). The CBASP@YoungAge project addresses this issue and represents an individualized, module-based intervention for children and adolescents with depressive disorders. CBASP@YoungAge is being implemented for the first time in a pilot study of outpatient psychotherapy for children and adolescents.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00023281
  •   2020/11/17
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  •   yes
  •   Approved
  •   Aktenzeichen 2020-75k, Marburg - Ethik-Kommission des Fachbereichs Psychologie der Philipps-Universität Marburg
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Secondary IDs

  •   U1111-1259-5590 
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34.1 -  Dysthymia
  •   F41.2 -  Mixed anxiety and depressive disorder
  •   F92.0 -  Depressive conduct disorder
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Interventions/Observational Groups

  •   CBASP@YoungAge: Outpatient therapy procedure (up to 24 individual sessions with the involvement of caregivers)
  •   "Treatment as usual" (standard treatment according to guidelines for psychotherapy)
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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)
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Depressive symptoms of the index patient. Operationalized by the Kinder DIPS (child or parent version)
Measurement: T1 (after diagnostics), T2 (therapy start), T3 (after therapy)

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Secondary Outcome

1. interaction behavior of the index patient and participating caregivers
- Impact Message Inventory (IMI-KJ) in the male and female version for children and caregivers

2. parenting behavior of the participating caregivers
- Erziehungsfragebogen (EFB)

3. global health index of the index patient
- KIDSCREEN-27 Index Health Questionnaire (Child and Parent Version)
4. health status of the participating caregivers
- Positive Mental Health Scale (PMH)
- Brief Symptom Inventory (BSI)

Measurement: T1 (after diagnostics), T2 (therapy start), T3 (after therapy)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2020/11/09
  •   25
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   10   Years
  •   21   Years
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Additional Inclusion Criteria

The index patients meet the criteria for depression as an index diagnosis (according to DSM-5)

The index patients and their participating caregiver are fluent in German language and writing

The intelligence quotient of the index patient is ≥ 80 (Measuring not older than 2 years)

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Exclusion Criteria

Already running psychotherapeutic treatments.

Severity of the disorder/ comorbid diseases requires an inpatient stay or specific outpatient treatment.

Acute suicidal ideation of the index patient.

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Addresses

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    • Philipps-Universität Marburg
    • 35037   Marburg
    • Germany
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    • Philipps-Universität Marburg
    • Ms.  Prof. Dr.  Hanna  Christiansen 
    • Gutenbergstraße 18
    • 35032  Marburg
    • Germany
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    • Universität Greifswald
    • Ms.  Prof. Dr.  Eva-Lotta  Brakemeier 
    • Franz-Mehring-Str. 47
    • 17489  Greifswald
    • Germany
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    • Philipps-Universität-Marburg
    • Ms.  Dipl.-Psych.  Nele  Dippel 
    • Gutenbergstraße 29
    • 35032  Marburg
    • Germany
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    • Philipps-Universität-Marburg
    • Ms.  Dipl.-Psych.  Nele  Dippel 
    • Gutenbergstraße 29
    • 35032  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Philipps-Universität Marburg
    • Ms.  Prof. Dr.  Hanna  Christiansen 
    • Gutenbergstraße 18
    • 35037  Marburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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