Children Affected by Rare Disease and Their Families Network
NCT ID: NCT04339465
Last Updated: 2022-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
687 participants
INTERVENTIONAL
2019-01-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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CARE-FAM
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).
CARE-FAM
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.
WEP-CARE
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 12 standardized writing tasks on a secured internet platform. The 12 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.
WEP-CARE
WEP-CARE is an online-intervention that 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 12 standardized writing tasks on a secured internet platform
CARE-FAM + WEP-CARE
The families will receive both the face-to-face intervention CARE-FAM and the online intervention WEP-CARE.
CARE-FAM
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.
WEP-CARE
WEP-CARE is an online-intervention that 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 12 standardized writing tasks on a secured internet platform
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.
No interventions assigned to this group
Interventions
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CARE-FAM
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.
WEP-CARE
WEP-CARE is an online-intervention that 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 12 standardized writing tasks on a secured internet platform
Eligibility Criteria
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Inclusion Criteria
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.
1 Day
21 Years
ALL
No
Sponsors
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Techniker Krankenkasse
OTHER
BARMER
OTHER
DAK Gesundheit
OTHER
KKH Kaufmännische Krankenkasse
UNKNOWN
BKK Mobil Oil
INDUSTRY
Achse e.V.
UNKNOWN
University of Ulm
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
University Hospital Schleswig-Holstein
OTHER
University Medical Center Rostock
OTHER
University Hospital Muenster
OTHER
University Hospital, Essen
OTHER
Ruhr University of Bochum
OTHER
Universitätsklinikum Köln
OTHER
University of Göttingen
OTHER
Hannover Medical School
OTHER
Evangelisches Klinikum Bethel
UNKNOWN
Charite University, Berlin, Germany
OTHER
DRK Kliniken Berlin Westend
UNKNOWN
Universitätsklinikum Leipzig
OTHER
University of Giessen
OTHER
University Hospital Freiburg
OTHER
Josefinum Augsburg
UNKNOWN
University Hospital Augsburg
OTHER
University Hospital, Saarland
OTHER
Jena University Hospital
OTHER
Leibniz Universität, Center for Health Economics Research Hannover
UNKNOWN
aQua-Institut
UNKNOWN
Silke Wiegand-Grefe, Prof. Dr.
OTHER
Responsible Party
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Silke Wiegand-Grefe, Prof. Dr.
Prof. Dr.
Locations
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Medical Center Klinikum Augsburg, Kinderklinik Augsburg, l. Klinik für Kinder- und Jugendliche
Augsburg, , Germany
Medical Center DRK Kliniken Berlin Westend, Klinik für Kinder- und Jugendmedizin
Berlin, , Germany
Medical Center Evangelisches Klinikum Bethel, Klinik für Kinder- und Jugendmedizin
Bielefeld, , Germany
University Medical Center Ruhr-Universität Bochum, Klinik für Kinder- und Jugendmedizin
Bochum, , Germany
University Medical Center Universitätsklinik Köln, Klinik für Kinder- und Jugendmedizin
Cologne, , Germany
University Medical Center Universitätsklinikum Essen, Kinderklinik I, Neuropädiatrie
Essen, , Germany
University Medical Center Universitätsklinikum Freiburg, Zentrum für Allgemeine Kinder- und Jugendmedizin, Klinik l
Freiburg im Breisgau, , Germany
University Medical Center Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen, Kinderklinik, Abteilung für Kinderneurologie, Sozialpädiatrie u. Epileptologie
Giessen, , Germany
University Medical Center Universitätsmedizin Göttingen, Klinik für Kinder- und Jugendmedizin
Göttingen, , Germany
University Medical Center Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin
Hamburg, , Germany
University Medical Center Medizinische Hochschule Hannover, Klinik für Pädiatrische Nieren-, Leber- und Stoffwechselerkrankungen
Hanover, , Germany
University Medical Center Universitätsklinikum des Saarlandes, Homburg, Klinik für Allgemeine Pädiatrie und Neonatologie
Homburg, , Germany
University Medical Center Universitätsklinik Jena, Klinik für Kinder- und Jugendmedizin
Jena, , Germany
University Medical Center Universitätsmedizin Leipzig, Universitätskinderklinik
Leipzig, , Germany
University Medical Center Charité-Universitätsmedizin Berlin, Klinik für Kinder- und Jugendmedizin
Mitte, , Germany
University Medical Center Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin
Münster, , Germany
University Medical Center Universitätsmedizin Rostock, Kinder- und Jugendklinik
Rostock, , Germany
Countries
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References
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Boettcher J, Filter B, Denecke J, Hot A, Daubmann A, Zapf A, Wegscheider K, Zeidler J, von der Schulenburg JG, Bullinger M, Rassenhofer M, Schulte-Markwort M, Wiegand-Grefe S. Evaluation of two family-based intervention programs for children affected by rare disease and their families - research network (CARE-FAM-NET): study protocol for a rater-blinded, randomized, controlled, multicenter trial in a 2x2 factorial design. BMC Fam Pract. 2020 Nov 20;21(1):239. doi: 10.1186/s12875-020-01312-9.
Other Identifiers
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U1111-1223-2871
Identifier Type: -
Identifier Source: org_study_id
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