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Children Affected by Rare Disease and Their Families Network (CARE-FAM-NET)

Primary Purpose

Rare Diseases

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CARE-FAM
WEP-CARE
Sponsored by
Silke Wiegand-Grefe, Prof. Dr.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rare Diseases focused on measuring rare disease, children and adolescents, e-mental health, early detection and early treatment of mental disorders

Eligibility Criteria

1 Day - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Family with at least one child between 0 and 21 years with a rare disease or 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.

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.

Sites / Locations

  • Medical Center Klinikum Augsburg, Kinderklinik Augsburg, l. Klinik für Kinder- und Jugendliche
  • University Medical Center Charité-Universitätsmedizin Berlin, Klinik für Kinder- und Jugendmedizin
  • Medical Center DRK Kliniken Berlin Westend, Klinik für Kinder- und Jugendmedizin
  • Medical Center Evangelisches Klinikum Bethel, Klinik für Kinder- und Jugendmedizin
  • University Medical Center Ruhr-Universität Bochum, Klinik für Kinder- und Jugendmedizin
  • University Medical Center Universitätsklinik Köln, Klinik für Kinder- und Jugendmedizin
  • University Medical Center Universitätsklinikum Essen, Kinderklinik I, Neuropädiatrie
  • University Medical Center Universitätsklinikum Freiburg, Zentrum für Allgemeine Kinder- und Jugendmedizin, Klinik l
  • University Medical Center Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen, Kinderklinik, Abteilung für Kinderneurologie, Sozialpädiatrie u. Epileptologie
  • University Medical Center Universitätsmedizin Göttingen, Klinik für Kinder- und Jugendmedizin
  • University Medical Center Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin
  • University Medical Center Medizinische Hochschule Hannover, Klinik für Pädiatrische Nieren-, Leber- und Stoffwechselerkrankungen
  • University Medical Center Universitätsklinikum des Saarlandes, Homburg, Klinik für Allgemeine Pädiatrie und Neonatologie
  • University Medical Center Universitätsklinik Jena, Klinik für Kinder- und Jugendmedizin
  • University Medical Center Universitätsmedizin Leipzig, Universitätskinderklinik
  • University Medical Center Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin
  • University Medical Center Universitätsmedizin Rostock, Kinder- und Jugendklinik

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

CARE-FAM

WEP-CARE

CARE-FAM + WEP-CARE

Treatment as usual

Arm Description

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 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.

The families will receive both the face-to-face intervention CARE-FAM and the online intervention WEP-CARE.

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.

Outcomes

Primary Outcome Measures

Mental health of parents (SCID)
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.

Secondary Outcome Measures

Sociodemographic information of the parents
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 (EQ-5D)
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) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Health-related quality of life of the parents (ULQIE)
Health-related quality of life of the parents, assessed from the perspective of the parents by the "Ulmer Lebensqualitäts-inventar für Eltern chronisch kranker Kinder" (ULQIE; Goldbeck & Storck, 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 parents (SF-12)
Health-related quality of life of the parents, assessed from the perspective of the parents 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 (Kidscreen-27)
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).
Health-related quality of life of the chronically-ill children/adolescents (DCGM-37)
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.
Mental health of the parents (PHQ)
Mental health of the parents, assessed from the perspective of the parents by the "Patient Health Questionnaire" (PHQ; Löwe, Spitzer, Zipfel & Herzog, 2002).
Mental health of the parents (BSI)
Mental health of the parents, assessed from the perspective of the parents by the "Brief Symptom Inventory" (BSI; Franke, 2000).
Mental health of the chronically-ill children/adolescents and the siblings (Kiddie-SADS-PL)
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).
Psychiatric disorders of the chronically-ill children/adolescents and the siblings (CBCL)
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).
Psychiatric disorders of the chronically-ill children/adolescents and the siblings (YSR)
Psychiatric disorders of the chronically-ill children/adolescents and the siblings, assessed 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).
Coping of the parents (CHIP-D)
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).
Coping of the chronically-ill children/adolescents and the siblings (Kidcope)
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).
Social support of the parents, of the chronically-ill children/adolescents and of the siblings (OSSQ)
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).
Family functioning (GARF)
Family functioning, assessed from the perspective of the therapist by the "Global Assessment of Relational Functioning" (GARF; Saß, Wittchen, Zaudig & Houben, 2003).
Relationships between siblings (SRQ)
Sibling relationship, assessed from the perspective of the siblings (from 10 years of age) by the "Sibling Relationship Questionnaire" (SRQ; Fuhrmann & Burmester, 1985).
Satisfaction with the relationship and parenting relationship of the parents (PFB)
Satisfaction with the relationship and parenting relationship of the parents, assessed from the perspective of the parents by the "Partnerschaftsfragebogen" (PFB; Hahlweg, 2016).
Eating behaviour of the chronically-ill children/adolescents (EDY-Q)
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).
Body-related eating behaviour of the chronically-ill children/adolescents (ChEDE-Q8)
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).
Elimination disorders of the chronically-ill children/adolescents (Anamnesebogen Enuresis/Funktionelle Harninkontinenz)
Elimination disorders of the chronically-ill children/adolescents, assessed from the perspective of the parents by the "Anamnesebogen Enuresis/Funktionelle Harninkontinenz" (von Gontard, 2010).
Treatment costs of the parents (CSSRI-DE)
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).
Treatment costs of the chronically-ill children/adolescents and the siblings (CAMHSRI-DE)
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).
Treatment assessment (FBB-T)
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).
Patient satisfaction (ZUF-8) Patient satisfaction
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).

Full Information

First Posted
April 1, 2020
Last Updated
September 14, 2022
Sponsor
Silke Wiegand-Grefe, Prof. Dr.
Collaborators
Techniker Krankenkasse, BARMER, DAK Gesundheit, KKH Kaufmännische Krankenkasse, BKK Mobil Oil, Achse e.V., University of Ulm, Universitätsklinikum Hamburg-Eppendorf, University Hospital Schleswig-Holstein, University Medical Center Rostock, University Hospital Muenster, University Hospital, Essen, Ruhr University of Bochum, Universitätsklinikum Köln, University of Göttingen, Hannover Medical School, Evangelisches Klinikum Bethel, Charite University, Berlin, Germany, DRK Kliniken Berlin Westend, Universitätsklinikum Leipzig, University of Giessen, University Hospital Freiburg, Josefinum Augsburg, University Hospital Augsburg, University Hospital, Saarland, Jena University Hospital, Leibniz Universität, Center for Health Economics Research Hannover, aQua-Institut
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1. Study Identification

Unique Protocol Identification Number
NCT04339465
Brief Title
Children Affected by Rare Disease and Their Families Network
Acronym
CARE-FAM-NET
Official Title
Children Affected by Rare Disease and Their Families Network
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Silke Wiegand-Grefe, Prof. Dr.
Collaborators
Techniker Krankenkasse, BARMER, DAK Gesundheit, KKH Kaufmännische Krankenkasse, BKK Mobil Oil, Achse e.V., University of Ulm, Universitätsklinikum Hamburg-Eppendorf, University Hospital Schleswig-Holstein, University Medical Center Rostock, University Hospital Muenster, University Hospital, Essen, Ruhr University of Bochum, Universitätsklinikum Köln, University of Göttingen, Hannover Medical School, Evangelisches Klinikum Bethel, Charite University, Berlin, Germany, DRK Kliniken Berlin Westend, Universitätsklinikum Leipzig, University of Giessen, University Hospital Freiburg, Josefinum Augsburg, University Hospital Augsburg, University Hospital, Saarland, Jena University Hospital, Leibniz Universität, Center for Health Economics Research Hannover, aQua-Institut

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 17 sites in 12 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.
Detailed Description
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: CAREFAM (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rare Diseases
Keywords
rare disease, children and adolescents, e-mental health, early detection and early treatment of mental disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The study is a prospective, randomized controlled multicenter study (RCT) with a factorial design with four groups: CAREFAM (face to face), WEP-CARE (online), both interventions, control group (TAU = treatment as usual).
Masking
Investigator
Masking Description
Assessors are blind regarding the randomization (group affiliation) of the families.
Allocation
Randomized
Enrollment
687 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CARE-FAM
Arm Type
Experimental
Arm Description
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).
Arm Title
WEP-CARE
Arm Type
Experimental
Arm Description
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.
Arm Title
CARE-FAM + WEP-CARE
Arm Type
Experimental
Arm Description
The families will receive both the face-to-face intervention CARE-FAM and the online intervention WEP-CARE.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CARE-FAM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
WEP-CARE
Intervention Description
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
Primary Outcome Measure Information:
Title
Mental health of parents (SCID)
Description
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.
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary Outcome Measure Information:
Title
Sociodemographic information of the parents
Description
Sociodemographic information of the parents, assessed from the perspective of the parents by ad-hoc items at the beginning of the study.
Time Frame
At baseline of the study
Title
Health-related quality of life of the parents (EQ-5D)
Description
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) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Health-related quality of life of the parents (ULQIE)
Description
Health-related quality of life of the parents, assessed from the perspective of the parents by the "Ulmer Lebensqualitäts-inventar für Eltern chronisch kranker Kinder" (ULQIE; Goldbeck & Storck, 2002) at the beginning of the study as well as six, 12 and 18 months after the randomization.
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Health-related quality of life of the parents (SF-12)
Description
Health-related quality of life of the parents, assessed from the perspective of the parents 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.
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Health-related quality of life of the chronically-ill children/adolescents (Kidscreen-27)
Description
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).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Health-related quality of life of the chronically-ill children/adolescents (DCGM-37)
Description
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.
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Mental health of the parents (PHQ)
Description
Mental health of the parents, assessed from the perspective of the parents by the "Patient Health Questionnaire" (PHQ; Löwe, Spitzer, Zipfel & Herzog, 2002).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Mental health of the parents (BSI)
Description
Mental health of the parents, assessed from the perspective of the parents by the "Brief Symptom Inventory" (BSI; Franke, 2000).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Mental health of the chronically-ill children/adolescents and the siblings (Kiddie-SADS-PL)
Description
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).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Psychiatric disorders of the chronically-ill children/adolescents and the siblings (CBCL)
Description
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).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Psychiatric disorders of the chronically-ill children/adolescents and the siblings (YSR)
Description
Psychiatric disorders of the chronically-ill children/adolescents and the siblings, assessed 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).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Coping of the parents (CHIP-D)
Description
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).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Coping of the chronically-ill children/adolescents and the siblings (Kidcope)
Description
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).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Social support of the parents, of the chronically-ill children/adolescents and of the siblings (OSSQ)
Description
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).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Family functioning (GARF)
Description
Family functioning, assessed from the perspective of the therapist by the "Global Assessment of Relational Functioning" (GARF; Saß, Wittchen, Zaudig & Houben, 2003).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Relationships between siblings (SRQ)
Description
Sibling relationship, assessed from the perspective of the siblings (from 10 years of age) by the "Sibling Relationship Questionnaire" (SRQ; Fuhrmann & Burmester, 1985).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Satisfaction with the relationship and parenting relationship of the parents (PFB)
Description
Satisfaction with the relationship and parenting relationship of the parents, assessed from the perspective of the parents by the "Partnerschaftsfragebogen" (PFB; Hahlweg, 2016).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Eating behaviour of the chronically-ill children/adolescents (EDY-Q)
Description
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).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Body-related eating behaviour of the chronically-ill children/adolescents (ChEDE-Q8)
Description
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).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Elimination disorders of the chronically-ill children/adolescents (Anamnesebogen Enuresis/Funktionelle Harninkontinenz)
Description
Elimination disorders of the chronically-ill children/adolescents, assessed from the perspective of the parents by the "Anamnesebogen Enuresis/Funktionelle Harninkontinenz" (von Gontard, 2010).
Time Frame
Change from baseline of the study at 6,12 and 18 months after the randomization
Title
Treatment costs of the parents (CSSRI-DE)
Description
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).
Time Frame
Change from baseline of the study at 6 months after the randomization
Title
Treatment costs of the chronically-ill children/adolescents and the siblings (CAMHSRI-DE)
Description
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).
Time Frame
Change from baseline of the study at 6 months after the randomization
Title
Treatment assessment (FBB-T)
Description
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).
Time Frame
Change from 6 months after randomization at 12 and 18 months.
Title
Patient satisfaction (ZUF-8) Patient satisfaction
Description
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).
Time Frame
Change from 6 months after randomization at 12 and 18 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Family with at least one child between 0 and 21 years with a rare disease or a suspected rare disease. Consent to participate in the study. Sufficient knowledge of the German language of parents and children. Insured at the participating insurance companies. 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.
Facility Information:
Facility Name
Medical Center Klinikum Augsburg, Kinderklinik Augsburg, l. Klinik für Kinder- und Jugendliche
City
Augsburg
Country
Germany
Facility Name
University Medical Center Charité-Universitätsmedizin Berlin, Klinik für Kinder- und Jugendmedizin
City
Berlin-Mitte
Country
Germany
Facility Name
Medical Center DRK Kliniken Berlin Westend, Klinik für Kinder- und Jugendmedizin
City
Berlin
Country
Germany
Facility Name
Medical Center Evangelisches Klinikum Bethel, Klinik für Kinder- und Jugendmedizin
City
Bielefeld
Country
Germany
Facility Name
University Medical Center Ruhr-Universität Bochum, Klinik für Kinder- und Jugendmedizin
City
Bochum
Country
Germany
Facility Name
University Medical Center Universitätsklinik Köln, Klinik für Kinder- und Jugendmedizin
City
Cologne
Country
Germany
Facility Name
University Medical Center Universitätsklinikum Essen, Kinderklinik I, Neuropädiatrie
City
Essen
Country
Germany
Facility Name
University Medical Center Universitätsklinikum Freiburg, Zentrum für Allgemeine Kinder- und Jugendmedizin, Klinik l
City
Freiburg
Country
Germany
Facility Name
University Medical Center Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen, Kinderklinik, Abteilung für Kinderneurologie, Sozialpädiatrie u. Epileptologie
City
Gießen
Country
Germany
Facility Name
University Medical Center Universitätsmedizin Göttingen, Klinik für Kinder- und Jugendmedizin
City
Göttingen
Country
Germany
Facility Name
University Medical Center Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
University Medical Center Medizinische Hochschule Hannover, Klinik für Pädiatrische Nieren-, Leber- und Stoffwechselerkrankungen
City
Hannover
Country
Germany
Facility Name
University Medical Center Universitätsklinikum des Saarlandes, Homburg, Klinik für Allgemeine Pädiatrie und Neonatologie
City
Homburg
Country
Germany
Facility Name
University Medical Center Universitätsklinik Jena, Klinik für Kinder- und Jugendmedizin
City
Jena
Country
Germany
Facility Name
University Medical Center Universitätsmedizin Leipzig, Universitätskinderklinik
City
Leipzig
Country
Germany
Facility Name
University Medical Center Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin
City
Münster
Country
Germany
Facility Name
University Medical Center Universitätsmedizin Rostock, Kinder- und Jugendklinik
City
Rostock
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.
Citations:
PubMed Identifier
33218310
Citation
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.
Results Reference
derived

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