Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007232

Trial Description

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Title

PRimary Prevention Of Depression in Offspring of Depressed Parents

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Trial Acronym

PRODO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this randomised controlled trial is to see whether a group-based
psychological intervention for families can reduce the inflated risk of depression in
children and adolescents who have at least one parent who suffers from depression (or who
has suffered from depressed in the child's lifetime).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007232
  •   2016/01/29
  •   2014/04/07
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02115880  (ClinicalTrials.gov)
  •   LP00216_PRODO  (Ludwig-Maximilians - University of Munich)
  •   LP00216 
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Health Condition or Problem studied

  •   Depression
  •   F32 -  Depressive episode
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Interventions/Observational Groups

  •   Behavioral: Prevention programme
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- Presence or absence of a depressive episode (child); time frame: T4 (9 months after completion of the programme); The German version of the Diagnostic Interview for Psychiatric Disorders in Children and Adolescents (Kinder DIPS) will be used to assess whether the child meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a depressive episode.

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Secondary Outcome

- Symptoms of depression (child); time frame: Within 2 weeks of the last session of the intervention (T2) as well as 3 months after the intervention (T3) and 9 months after the intervention (T4); Self-reported symptoms of depression will be collected using the German questionnaires "Depression Inventory for Children and Adolescents" (DIKJ) and Beck Depression Inventory (BDI-II; depending on the child's age).
- Psychopathological symptoms (child); time frame: Within 2 weeks of the last session of the intervention (T2) as well as 3 months after the intervention (T3) and 9 months after the intervention (T4); More general internal and external psychopathological symptoms will be measured using German versions of the questionnaires "Youth Self-Report" (YSR; child self-report) and "Child Behaviour Checklist" (CBCL; parent-report).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2014/05/31
  •   100
  •   [---]*
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   17   Years
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Additional Inclusion Criteria

- At least one parent who meets diagnostic criteria for a current (or past, during the
child's lifetime) diagnosis of depression

- The participating child is aged 8-17

- The participating child has an IQ of at least 85

- Both child and parent(s) have adequate German-language skills

- Both child and parents consent to intervention sessions being video-recorded

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Exclusion Criteria

- The participating parent(s) has current symptoms of bipolar disorder, psychotic
symptoms, personality disorder, substance addiction, or is suicidal

- The participating child meets criteria for a current, or previous, episode of any
psychiatric disorder

- The participating child is undergoing or has undergone treatment for depression

- The participating child or parent have serious symptoms of a disorder (or are in
crisis) that may hamper their ability to take part in the study

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Addresses

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    • Ludwig-Maximilians - University of Munich
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    •   [---]*
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    • Bavarian State Ministry of Environment, Public Health and Consumer Protection
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    •   [---]*
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    • Ludwig-Maximilians - University of Munich
    • Gerd Schulte-Körne, MD 
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    •   [---]*
    •   [---]*
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    • Belinda J Platt, DPhil. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   [---]*
  •   Compas BE, Forehand R, Thigpen JC, Keller G, Hardcastle EJ, Cole DA, Potts J, Watson KH, Rakow A, Colletti C, Reeslund K, Fear J, Garai E, McKee L, Merchant MJ, Roberts L. Family group cognitive-behavioral preventive intervention for families of depressed parents: 18- and 24-month outcomes. J Consult Clin Psychol. 2011 Aug;79(4):488-99. doi: 10.1037/a0024254.; 21707137
  •   Compas BE, Forehand R, Keller G, Champion JE, Rakow A, Reeslund KL, McKee L, Fear JM, Colletti CJ, Hardcastle E, Merchant MJ, Roberts L, Potts J, Garai E, Coffelt N, Roland E, Sterba SK, Cole DA. Randomized controlled trial of a family cognitive-behavioral preventive intervention for children of depressed parents. J Consult Clin Psychol. 2009 Dec;77(6):1007-20. doi: 10.1037/a0016930.; 19968378
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.