Trial document



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  DRKS00015859

Trial Description

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Title

Children affected by rare diseases, their siblings and their families (CARE-FAM-NET)

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Trial Acronym

CARE-FAM-NET

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URL of the Trial

https://www.carefamnet.org/

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Brief Summary in Lay Language

Families of children with rare diseases (i.e., not more than 5 out of 10.000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and his/her siblings. The project at hand will test two innovative forms of care (CARE-FAM and WEP-CARE) at 18 sites in 13 federal states of Germany. The goal is to improve the mental health and quality of life of children affected by rare diseases and their relatives in a sustainable manner. If successful, these interventions will be introduced into regular care.

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Brief Summary in Scientific Language

The central objective of the study at hand is to close the supply gap for families with children and adolescents affected by rare diseases. Two innovative forms of care (CARE-FAM and WEP-CARE) will be implemented and evaluated at the 18 participating study sites. Both interventions include psychological diagnostics, early detection and treatment of concomitant mental diseases.
The study is a prospective, randomized controlled multicenter study (RCT) with a factorial design with four groups: CARE-FAM (face to face), WEP-CARE (online), both interventions, control group (TAU = treatment as usual).
Central psychosocial outcomes will be assessed at four time points (i.e., Baseline and after six, 12 and 18 months) from the perspectives of the parents, the affected child and the siblings (0 – 9 years only external assessment; from 10 years of age additional self-assessment) and the professionals.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00015859
  •   2018/12/18
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  •   yes
  •   Approved
  •   PV5749, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1223-2871 
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Health Condition or Problem studied

  •   rare diseases
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Interventions/Observational Groups

  •   The face-to-face intervention CARE-FAM is a family-based intervention for the diagnostic, early detection and early treatment of mental health issues of children affected by rare diseases, their siblings and their parents. CARE-FAM is a brief low-frequency intervention comprising six to eight sessions per family over a period of six months. Following a preliminary talk, 2 sessions with the parents, 1 session with each affected child and each sibling and 3 sessions with the whole family will take place. This low-frequency approach (sessions every 2 to 3 weeks) allows families to integrate the intervention into their daily life. Upon request, the sessions will take place at the family’s home (home-treatment). The disease of the affected child and the burdens on the family associated with this disease will be discussed with all family members. Key topics of the intervention are the coping with the disease, the social situation of the family, family relationships, current and future professional support, the mental health and the quality of life and life satisfaction of all family members. If further support is required, families will be placed at existing health care services. The intervention is not limited to any disorder and all sessions are described in a manual. The aim of this innovative form of care is the improvement of the mental health and the quality of life of all family members.
  •   The Online intervention WEP-CARE addresses parents of children and adolescents affected by rare diseases. The program is based on principles of cognitive-behavioral writing therapy. Supported by trained professionals, the participants perform 10 standardized writing tasks on a secured internet platform. The 10 writing tasks will be conducted with a weekly frequency and participants will receive personalized feedback. WEP-CARE aims at enhancing mental health problems and the coping strategies of the family.
  •   The families will receive both the face-to-face intervention CARE-FAM and the online intervention WEP-CARE.
  •   "Treatment as usual":
    The treatment as usual implies that families of the control group receive the treatment that is customary in regular care. Thus, these families normally don't receive any post-treatment. If, however, a member of a control group family appears to have an urgent need for treatment (every family receives a comprehensive diagnostic investigation at the beginning of the study), the respective family will be placed in the ambulatory care system.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Treatment
  •   Factorial
  •   N/A
  •   N/A
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Primary Outcome

Proportion of parents without mental abnormities among the parents with initial mental abnormities, assessed by the external, independent “Structured clinical interview for DSM-IV” (SCID; Wittchen, Zaudig & Fydrich,1997) 18 months after randomization.

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Secondary Outcome

Sociodemographic information of the parents, assessed from the perspective of the parents by ad-hoc items at the beginning of the study.
Health-related quality of life of the parents, assessed from the perspective of the parents by the EQ-5D (Brooks, Rabin & Charro, 2003; Hinz, Klaiberg, Brahler & Konig, 2006), by the „Ulmer Lebensqualitäts-inventar für Eltern chronisch kranker Kinder“ (ULQIE; Goldbeck & Storck, 2002) and by the “Short Form 12” (SF-12; Bullinger & Kirchberger, 1998) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Health-related quality of life of the chronically-ill children/adolescents, assessed from the perspective of the child/adolescent (from 10 years of age) and from the perspective of the parents by the „Disabkids Chronic Generic Measure“ (DCGM-37; Bullinger, Schmidt, Petersen & The DISABKIDS Group, 2002) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Health-related quality of life of the chronically-ill children/adolescents and of the siblings, assessed from the perspective of the child/adolescent (from 10 years of age) and from the perspective of the parents by the Kidscreen-27 (The KIDSCREEN Group Europe, 2006) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Mental health of the parents, assessed from the perspective of the parents by the “Patient Health Questionnaire” (PHQ; PHQ; Löwe, Spitzer, Zipfel & Herzog, 2002) and by the corresponding “GAD-7” as well as by the “Brief Symptom Inventory“ (BSI; BSI; Franke, 2000) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Mental health of the chronically-ill children/adolescents and the siblings, assessed from the perspective of the parents and from the perspective of the children/adolescents (from 10 years of age) by an external independent interview „Diagnostic Interview Kiddie-Sads-Present and Lifetime Version” (Kiddie-SADS-PL; Delmo, Weiffenbach, Gabriel, Stadler & Poustka, 2001) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Psychiatric disorders of the chronically-ill children/adolescents and the siblings, assessed from the perspective of the parents by the “Child Behaviour Checklist” (CBCL; Döpfner, Pflück, Kinnen & Arbeitsgruppe Deutsche Child Behavior Checklist, 2014) and from the perspective of the children/adolescents (from 10 years of age) by the “Youth Self Report” (YSR; Döpfner, Pflück, Kinnen & Arbeitsgruppe Deutsche Child Behavior Checklist, 2014) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Coping of the parents, assessed from the perspective of the parents by the German version of the „Coping Health Inventory for Parents“ (CHIP-D; McCubbin, McCubbin, Cauble & Goldbeck, 2001) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Coping of the chronically-ill children/adolescents and the siblings, assessed from the perspective of the children/adolescents (from 10 years of age) by the „Kidcope Checklist“ (Kidcope; Spirito, Stark & Williams, 1988) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Social support of the parents, of the chronically-ill children/adolescents and of the siblings, assessed from the perspective of the parents, of the chronically-ill children/adolescents and from the sibling, respectively, by the „Oslo Social Support Questionnaire“ (OSSQ; Dalgard, 2006) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Family functioning, assessed from the perspective of the therapist by the „Global Assessment of Relational Functioning“ (GARF; Saß, Wittchen, Zaudig & Houben, 2003) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Sibling relationship, assessed from the perspective of the siblings (from 10 years of age) by the „Sibling Relationship Questionnaire“ (SRQ; Fuhrmann & Burmester, 1985) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Satisfaction with the relationship and parenting relationship of the parents, assessed from the perspective of the parents by the „Partnerschaftsfragebogen“ (PFB; Hahlweg, 2016) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Eating behaviour of the chronically-ill children/adolescents, assessed from the perspective of the parents and from the perspective of the chronically-ill children/adolescents (from 10 years of age) by the „Eating Disorders in Youth - Questionnaire“ (EDY-Q; van Dyck & Hilbert, 2016) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Body-related eating behaviour of the chronically-ill children/adolescents, assesse from the persepective of the chronically-ill children/adolescents (from 10 years of age) by the „Eating Disorder Examination - Questionnaire (Short Form)“ (ChEDE-Q8; Kliem, Schmidt, Vogel, Hiemisch, Kiess & Hilbert, 2017) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Elimination disorders of the chronically-ill children/adolescents, assessed from the perspective of the parents by the “Anamnesebogen Enuresis/Funktionelle Harninkontinenz" (von Gontard, 2010) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Adherence of the parents, assessed from the perspective of the parents by ad-hoc items (?) at the beginning of the study as well as six months after the randomization.
Previous diagnostics of the rare diseases of the chronically-ill children/adolescents, assessed from the perspective of the parents by ad-hoc items (?) at the beginning of the study.
Treatment costs of the parents, assessed from the perspective of an external rater by the German version of the "Client Socioeconomic and Services Receipt Inventory" (CSSRI-DE; Roick, Kilian, Matschinger, Bernert, Mory & Angermeyer, 2001) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Treatment costs of the chronically-ill children/adolescents and the siblings, assessed from the perspective of an external rater by the German version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian, Losert, McDaid, Park, Knapp, Beecham, Kusakovskaja, Murauskiene & the CAMHEE Project, 2009) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Previous experiences with the quality of supply of the parents and of the chronically-ill children/adolescents as well as of the siblings, assessed from the perspective of the parents and from the perspective of the children/adolescents (from 10 years of age) by ad-hoc items at the beginning of the study.
Treatment expectations of the parents, of the chronically-ill children/adolescents as well as of the siblings, assessed from the perspective of the parents and from the perspective of the children/adolescents (from 10 years of age) by ad-hoc items at the beginning of the study.
Objectives of the treatment of the parents, the chronically-ill children/adolescents as well as of the siblings, assessed from the perspective of the parents and from the perspective of the children/adolescents (from 10 years of age) and from the perspective of the therapist by ad-hoc items at the beginning of the study.
Satisfaction with the treatment of the parents, of the chronically-ill children/adolescents as well as of the siblings, assessed from the perspective of the parents and from the perspective of the children/adolescents (from 10 years of age) and from the perspective of the therapist by ad-hoc items six, 12 and 18 months after randomization.
Treatment assessment of the parents and the chronically ill children/adolescents and their siblings, in self-assessment from the age of 10 years and by the therapist, assessed on the basis of the treatment assessment questionnaire (FBB-T; Mattejat & Remschmid, 1998) and on the basis of ad hoc items 6, 12 and 18 months after randomization. Patient satisfaction of the parents and the chronically ill children/adolescents and their siblings, assessed on the basis of the questionnaire on patient satisfaction (ZUF-8; Schmid & Nübling, 2002) and on the basis of ad hoc items in the self-assessment from the age of 10 and in the external assessment by the parents 6, 12 and 18 months after randomization.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/01/01
  •   620
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. Families with at least one child between the age of 0 and 21 years with a rare disease or with a suspected rare disease.
2. Consent to participate in the study.
3. Sufficient knowledge of the German language of parents and children.
4. Insured at the participating insurance companies.

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Exclusion Criteria

Severe psychiatric disorders and impairments with acute symptoms such as suicidal tendencies, severe depression, addictions, acute psychotic symptoms etc., which will not be sufficiently supplied by this new low-frequency intervention. Children and parents with acute treatment demand in the control group will be placed at psychotherapists. Nevertheless, they stay in the control group

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf Klinik für Kinder- und Jugendpsychiatrie, -psychotherapie und -psychosomatik
    • Ms.  Prof. Dr.  Silke  Wiegand-Grefe 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    • Techniker Krankenkasse
    • Mr.  Markus  Jochem 
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    • Barmer-GEK
    • Ms.  Dr.  Ursula  Marschall 
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    • DAK-Gesundheit
    • Ms.  Petra  Heßmann 
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    • KKH Kaufmännische Krankenkasse
    • Ms.  Corinna  Beutel 
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    • BKK Mobil Oil
    • Ms.  Sandra  LoBianco 
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    • Achse e.V.
    • Ms.  Christine  Mundlos 
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    • Universitätsklinikum Hamburg-Eppendorf Institut und Poliklinik für Medizinische Psychologie
    • Mr.  PD Dr.  Jörg  Dirmaier 
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    • Universität Ulm Klinik für Kinder- und Jugendpsychiatrie und Psychotherapie Universität Ulm WEP-CARE
    • Mr.  Prof. Dr.   Paul  Plener 
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    • Universitätsklinikum Hamburg-Eppendorf Klinik für Kinder- und Jugendmedizin
    • Mr.  PD Dr.  Jonas  Denecke 
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    • Universitätsklinikum Schleswig-Holstein Klinik für Kinder- und Jugendmedizin II
    • Mr.  Prof. Dr.  Ulrich  Stephani 
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    • Universitätsmedizin Rostock Kinder- und Jugendklinik
    • Mr.  Prof. Dr.  Michael  Radke 
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    • Universitätsmedizin Rostock Institut für Medizinische Psychologie und Medizinische Soziologie
    • Mr.  Prof. Dr.  Peter  Kropp 
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    • Universitätsklinikum Münster Klinik für Kinder- und Jugendmedizin
    • Mr.  Prof. Dr.  Frank  Rutsch 
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    • Universitätsklinikum Münster Klinik für Kinder- und Jugendmedizin (Psychosomatik)
    • Ms.  Dr.  Martina  Monninger 
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    • Universitätsklinikum Essen Kinderklinik I, Neuropädiatrie
    • Ms.  Prof. Dr.  Ulrike  Schara 
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    • Universitätsklinikum Essen Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
    • Mr.  Prof. Dr.  Johannes  Hebebrand 
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    • Universitätsklinikum der Ruhr-Universität Bochum Klinik für Kinder- und Jugendmedizin
    • Mr.  Prof. Dr.  Thomas  Lücke 
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    • Ruhr-Universität Bochum, Institut für Psychologie Arbeitseinheit Klinischer Kinder- und Jugendpsychologie
    • Ms.  Prof. Dr.  Silvia  Schneider 
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    • Universitätsklinik Köln Klinik für Kinder- und Jugendmedizin
    • Mr.  Prof. Dr.  Jörg  Dötsch 
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    • Universitätsklinik Köln Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
    • Mr.  Prof. Dr.  Stephan  Bender 
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    • Universitätsmedizin Göttingen Klinik für Kinder- und Jugendmedizin, SPZ
    • Mr.  Prof. Dr.  Knut  Brockmann 
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    • Universitätsmedizin Göttingen Klinik für Psychosomatische Medizin und Psychotherapie
    • Mr.  Prof. Dr.  Eric  Leibing 
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    • Medizinische Hochschule Hannover Klinik für Pädiatrische Nieren-, Leber- und Stoffwechselerkrankungen
    • Mr.  Prof. Dr.  Anibh  Das 
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    • Medizinische Hochschule Hannover Forschungs- und Lehreinheit Medizinische Psychologie
    • Ms.  Prof. Dr.  Karin  Lange 
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    • Evangelisches Klinikum Bethel Kinder- und Jugendpsychiatrie und Psychotherapie
    • Mr.  Prof. Dr.  Michael  Siniatchkin 
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    • Charité-Universitätsmedizin Berlin Klinik für Kinder- und Jugendmedizin
    • Ms.  Prof. Dr.  Angelika  Kaindl 
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    • Charité-Universitätsmedizin Berlin Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
    • Ms.  PD Dr.  Sibylle  Winter 
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    • DRK Kliniken Berlin Westend Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Prof. Dr.  Arpad  von Moers 
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    • DRK Kliniken Berlin Westend Klinik für Kinder- und Jugendmedizin
    • Mr.  Prof. Dr.  Michael  von Aster 
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    • Universitätsmedizin Leipzig Universitätskinderklinik
    • Mr.  Prof. Dr.  Wieland  Kieß 
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    • Universitätsmedizin Leipzig Medizinische Psychologie und Medizinische Soziologie
    • Ms.  Prof. Dr.  Anja  Hilbert 
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    • Universitätsklinikum Gießen und Marburg Kinderklinik, Abteilung für Kinderneurologie
    • Mr.  Prof. Dr.  Bernd  Neubauer 
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    • Universitätsklinikum Gießen und Marburg Klinik für Psychosomatik und Psychotherapie
    • Mr.  Prof. Dr.  Johannes  Kruse 
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    • Universitätsklinikum Freiburg Zentrum für Allgemeine Kinder- und Jugendmedizin, Klinik I
    • Ms.  Prof. Dr.  Ute  Spiekerkötter 
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    • Universitätsklinikum Freiburg Klinik für Psychiatrie, Psychotherapie und Psychosomatik des Kindes- und Jugendalters
    • Mr.  Prof. Dr.  Christian  Fleischhaker 
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    • Klinikum Augsburg Kinderklinik Augsburg I, Klinik für Kinder und Jugendliche
    • Mr.  Prof. Dr. Dr.  Michael  Frühwald 
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    • Josefinum Augsburg Klinik für Kinder- und Jugendpsychiatrie
    • Ms.  Prof. Dr.  Michele  Noterdaeme 
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    • Universitätsklinikum des Saarlandes Klinik für Allgemeine Pädiatrie und Neonatologie
    • Mr.  Prof. Dr.  Michael  Zemlin 
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    • Universitätsklinikum des Saarlandes Kinder- und Jugendpsychiatrie
    • Mr.  Prof. Dr.  Alexander  von Gontard 
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    • Universitätsklinik Jena Klinik für Kinder- und Jugendmedizin
    • Mr.  Prof. Dr.  Ulrich  Brandl 
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    • Universitätsklinik Jena Sozialpädiatrisches Zentrum
    • Ms.  Dr.  Andrea  Dieckmann 
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    • Leibniz Universität, Center for Health Economics Research Hannover (CHERH)
    • Mr.  Prof. Dr.  Matthias  Graf von der Schulenburg 
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    • Universitätsklinikum Hamburg-Eppendorf Medizinische Biometrie und Epidemiologie
    • Mr.  Prof. Dr.  Karl  Wegscheider 
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    • aQua-Institut
    • Mr.  Dr.  Gerald  Willms 
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    • Universitätsklinikum Hamburg-Eppendorf Institut und Poliklinik für Medizinische Psychologie
    • Ms.  Prof. Dr.  Monika  Bullinger 
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    • Universitätsklinikum Hamburg-Eppendorf Klinik für Kinder- und Jugendpsychiatrie, -psychotherapie und -psychosomatik
    • Ms.  Prof. Dr.  Silke  Wiegand-Grefe 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Hamburg-Eppendorf Klinik für Kinder- und Jugendpsychiatrie, -psychotherapie und -psychosomatik
    • Ms.  Dr.  Bonnie  Filter 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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end of 1:n-Block addresses
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim GB-A
    • Postfach 120606
    • 10623  Berlin
    • Germany
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end of 1:n-Block material support
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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.