An interventional study of CARE-FAM and WEP-CARE in Rare Diseases, sponsored by Silke Wiegand-Grefe, Prof. Dr.. Status unknown at 17 sites in Germany. Open to participants aged 1 Day to 21 Years. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by Silke Wiegand-Grefe, Prof. Dr. · Not applicable, Interventional, and Supportive care
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.
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.
203 studies on the registry are indexed under Rare Diseases; 112 are open to participants now.
This study's enrollment of 687 is above the median of 57 across 71 interventional studies indexed under Rare Diseases.
Browse Rare Diseases studies →Silke Wiegand-Grefe, Prof. Dr. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Inclusion Criteria:
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.
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).
Behavioral: CARE-FAM
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.
Behavioral: WEP-CARE
The families will receive both the face-to-face intervention CARE-FAM and the online intervention WEP-CARE.
Behavioral: CARE-FAM · Behavioral: 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.
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 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
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.
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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.
Time frame: At baseline 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.
Time frame: Change from baseline of the study at 6,12 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.
Time frame: Change from baseline of the study at 6,12 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.
Time frame: Change from baseline of the study at 6,12 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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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.
Time frame: Change from baseline of the study at 6,12 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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Time frame: Change from baseline of the study at 6 months after the randomization
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).
Time frame: Change from baseline of the study at 6 months after the randomization
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).
Time frame: Change from 6 months after randomization at 12 and 18 months.
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).
Time frame: Change from 6 months after randomization at 12 and 18 months.
Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available.
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Silke Wiegand-Grefe, Prof. Dr.