Trial document




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  DRKS00015017

Trial Description

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Title

Development of a psycho-educative prevention program for children and adolescents with parents in detoxification treatment

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Trial Acronym

PEPE Kids

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URL of the Trial

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Brief Summary in Lay Language

The project focuses on the development of a brochure and website containing information and support offers for children of parents with substance use issues. The materials are supposed especially address the situation of children and adolescents with parents currently in detoxification treatment. Main goal is to receive feedback on the materials from affected children, to adjust them specifically to their needs. Additionally, existing resources and supports needs of affected children are intended to be identified.

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Brief Summary in Scientific Language

The project primarily aims at the development of a psycho-educative intervention for children and adolescents whose parents are currently in qualified detoxification treatment (legal and illegal substances). It is relevant that the materials developed can be implemented easily in a clinical setting and strengthen children’s psychosocial resources and coping strategies in an age-appropriate way. The target group is approached in course of their parents’ detoxification treatment.
To meet the needs of different developmental stages of children and adolescents, the materials are separately designed for a) children between the age of 8 and 12 and b) adolescents between the age of 13 and 16.
The prevention materials relate to coping with the parental addiction, reflection on own substance use/abuse, enhancing stress management and problem solving skills as well as information on target group specific support offers. For the younger group of children, a printed brochure will be developed, while the older adolescents will receive access to interactive online modules. Primary research questions concern the practicability and acceptance of the measure in a clinical setting with the intended target group. Secondary research questions relate to the analysis of proportions and characteristics of parents in detoxification treatment and their children.
Overarching goal of the study is the selective primary prevention of disorders relating to substance use and associated psychiatric disorders as well the enhancement of mental health and resources of the specific high-risk group of children whose parents are currently in detoxification treatment.

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Organizational Data

  •   DRKS00015017
  •   2019/02/19
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  •   yes
  •   Approved
  •   /, Köln - Katholische Hochschule NRW, K2 Ethikkommission
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Secondary IDs

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Health Condition or Problem studied

  •   F90-F98 -  Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
  •   F10-F19 -  Mental and behavioural disorders due to psychoactive substance use
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Interventions/Observational Groups

  •   Children and adolescents are asked to evaluate the prevention materials one time after receiving them. In addition, personal and social resources, emotion regulation strategies and health related quality of life are assessed in the cross-sectional design.
    Parents currently in qualified detoxification treatment also participate in a onetime assessment reporting on their children’s health related quality of life, behavioral strengths and difficulties and stress management strategies.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Positive acceptance and evaluation of the developed materials for children and adolescents (free feedback and 5-point Rating scale) with regard to content, benefits and appearance. Singular measurement with the target group.

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Secondary Outcome

Identification of available resources (FRKJ) of children as well as other needs for support of parents and children with regard to health-related quality of life (Kidscreen), behavioural problems (SDQ) and emotion regulation (ERQ).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2019/09/01
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Parents who are currently in qualified detoxification treatment (legal and illegal substances) and have children between 8 and 16 years.

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Exclusion Criteria

no parental detoxification treatment, other age group, no parental consent for participation, lacking knowledge of the German language

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Addresses

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    • Deutsches Institut für Sucht- und Präventionsforschung, Katholische Hochschule NRW
    • Mr.  Prof. Dr.  Michael  Klein 
    • Wörthstr. 10
    • 50668  Köln
    • Germany
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    • Deutsches Institut für Sucht- und Präventionsforschung, Katholische Hochschule NRW
    • Mr.  Prof. Dr.  Michael   Klein 
    • Wörthstr. 10
    • 50668  Köln
    • Germany
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    • Deutsches Institut für Sucht- und Präventionsforschung, Katholische Hochschule NRW
    • Ms.  Dipl. Psych.  Janina  Dyba 
    • Wörthstr. 10
    • 50668  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Postfach 12606
    • 10623  Berlin
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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