Trial document





This trial has been registered retrospectively.
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  DRKS00025125

Trial Description

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Title

A prospective investigation of developmental trajectories of psychosocial adjustment in adolescents facing a chronic condition

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Trial Acronym

COACH

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URL of the Trial

https://www.uni-pots-dam.de/de/beratungspsychologie/forschung/laufende-projekte; https://www.gesundheitsforschung-bmbf.de/de/coach-patientenzentrierte-interdisziplinare-gesundheitsversorgung-bei-chronisch-kranken-7261.php

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Brief Summary in Lay Language

Chronic diseases mean facing an additional challenge in life. Individuals with chronic diseases are at higher risk of psychological stress and reduced health-related quality of life. Especially during adolescence, youths are confronted with a range of developmental tasks, e.g. finding a partner, preparing for future family and work life, accepting the own body, which can strongly interfere with the demands of a chronic disease.
The study aims to understand which personal strengths, skills and resources help adolescents and emerging adults to cope with the challenges of a chronic disease (type 1 diabetes, juvenile idiopathic arthritis, cystic fibrosis).

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Brief Summary in Scientific Language

Based on resilience-in-illness models, we will examine resources and adaptive processes in adolescents with a chronic disease (type 1 diabetes, juvenile idiopathic arthritis, cystic fibrosis). These analyses might contribute to a lasting improvement of the treatment of this patient group. Therefore, we investigate the dynamic relationship between intrapersonal resilience factors (resiliency) and coping strategies in order to explain individual differences in psychosocial adjustment of adolescents with chronic conditions. The key question is whether resiliency and coping strategies play a significant role in psychosocial adjustment beyond the influence of general demographic and disease-related factors and as a consequence whether possible high-risk groups could be identified. A deeper understanding of adaptive, potentially modifiable processes within this sensitive developmental phase will help to develop novel, tailored interventions for positive adaptation in youths with chronic diseases. These strategies should not only support those at risk but also promote the maintenance of a successful adaptation.

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

Yes

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Description IPD sharing plan:

The following documents will be provided:
• Study protocol
• Scale manual

Period:
• Fully anonymized data will be made available after a moratorium of five years.

Procedure:
• A reasonable request must be made.

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Organizational Data

  •   DRKS00025125
  •   2021/05/17
  •   [---]*
  •   yes
  •   Approved
  •   37/2018, Universität Potsdam, Ethikkommission, Am Neuen Palais 10, Haus 9, 14469 Potsdam
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Secondary IDs

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Health Condition or Problem studied

  •   E10 -  Type 1 diabetes mellitus
  •   M08 -  Juvenile arthritis
  •   E84 -  Cystic fibrosis
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Interventions/Observational Groups

  •   Children and adolescents with chronic physical diseases (type 1 diabetes, juvenile idiopathic arthritis or cystic fibro-sis), participate in an online questionnaire survey via SoSci-Survey at two measurement time points one year apart. Two groups are considered: Adolescents who were conspicuous in a screening for anxiety (GAD-7) or depression (PHQ-9) and those who were inconspicous (GAD7 and PHQ-9 below 7 points). The subjects are asked about the following aspects:

    Sociodemographic and disease specific information
    • Disease severity, age at disease diagnosis, etc.

    Outcome: Health related quality of life and well-being (T1 and T2)
    • Well-being (WHO-5)
    • Health related quality of life (DCGM-37)
    • Satisfaction with life (SWLS)
    • General well-being (SAM)

    Resources (T1 and T2)
    • Resources (FRKJ 8-16)
    • Self-control (SCS-K-D)
    • Self-compassion (SCS-D Kurzversion)
    • Social skills (FSK-KJ)
    • Social support in coping with illness (BSSS)
    • Body functionality (FAS)

    Coping strategies (T1 and T2)
    • Strategies (CODI)
    • Problem solving (SSKJ 3-8)
    • Cognitive emotion regulation (ERQ; CERQ)
    • Posttraumatic growth (BFSC)

    Psychopathology (T2)
    • Depression (PHQ-8)
    • Anxiety (GAD-7)

    Developmental tasks and critical life events (T2)
    • Developmental Tasks
    • Critical Life Events

    Psychological distress (T2)
    • Perceived stress (PSS-4)
    • Impact of Covid pandemic

    Corona-specific Items
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Health related quality of life (DCGM-37/DCGM-12)

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Secondary Outcome

Well-being (WHO-5), Satisfaction with life (SWLS), Depression (PHQ-9), Anxiety (GAD-7), Posttraumatic growth (BFSC)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/06/03
  •   450
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Recruitment conducted through institutions participating in the three disease-related patient registries (see homepage for overview of cooperating clinics).

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Exclusion Criteria

none

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Potsdam Department Psychologie Beratungspsychologie
    • Ms.  Prof. Dr.  Petra  Warschburger 
    • Karl-Liebknecht-Straße 24-25
    • 14476  Potsdam
    • Germany
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    • German Rheumatism Research Center (DRFZ), Program Area Epidemiology, and University Medicine Charité Berlin
    • Ms.  Prof. Dr.  Kirsten  Minden 
    • Berlin
    • Germany
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    •   0049 30 28460669
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    •   minden at drfz.de
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    • Pediatric pulmonology and immunology, Charité University Hospital Berlin
    • Ms.  PD Dr.  Doris  Staab 
    • Berlin
    • Germany
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    • Institute of Epidemiology and medical Biometry, ZIBMT, University of Ulm
    • Mr.  Prof. Dr.  Reinhard W.  Holl 
    • 89081  Ulm
    • Germany
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    • University of Düsseldorf, Department of General Pediatrics, Neonatology and Pediatric Cardiology
    • Mr.  Prof. Dr.  Thomas  Meissner 
    • Düsseldorf
    • Germany
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    • Abteilung für Klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik, Universität Ulm
    • Mr.  Prof. Dr.  Harald  Baumeister 
    • Ulm
    • Germany
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    • Sektion Gesundheitsökonomie und Versorgungsfor-schung, Klinik für Psychiatrie und Psychotherapie II, Universität Ulm
    • Mr.  Prof. Dr. rer. soc.  Reinhold  Kilian 
    • Ulm
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Universität Potsdam Department Psychologie Beratungspsychologie
    • Ms.  Prof. Dr.  Petra  Warschburger 
    • Karl-Liebknecht-Straße 24-25
    • 14476  Potsdam
    • Germany
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  • start of 1:1-Block address public-contact
    • Universität Potsdam Department Psychologie Beratungspsychologie
    • Ms.  Prof. Dr.  Petra  Warschburger 
    • Karl-Liebknecht-Straße 24-25
    • 14476  Potsdam
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • Kapelle-Ufer 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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