Children Affected by Rare Disease and Their Families Network
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 687
- 试验地点
- 17
- 主要终点
- Mental health of parents (SCID)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Assessors are blind regarding the randomization (group affiliation) of the families.
入排标准
- 年龄范围
- 1 Day 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: CARE-FAM (Behavioral)
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.
干预措施: WEP-CARE (Behavioral)
CARE-FAM + WEP-CARE
The families will receive both the face-to-face intervention CARE-FAM and the online intervention WEP-CARE.
干预措施: CARE-FAM (Behavioral)
CARE-FAM + WEP-CARE
The families will receive both the face-to-face intervention CARE-FAM and the online intervention WEP-CARE.
干预措施: WEP-CARE (Behavioral)
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.
结局指标
主要结局
Mental health of parents (SCID)
时间窗: Change from baseline of the study at 6,12 and 18 months after the randomization
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.
次要结局
- Family functioning (GARF)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Sociodemographic information of the parents(At baseline of the study)
- Health-related quality of life of the parents (EQ-5D)(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)(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)(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)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Coping of the parents (CHIP-D)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Relationships between siblings (SRQ)(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)(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)(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)(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)(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)(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)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Mental health of the parents (BSI)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Health-related quality of life of the parents (ULQIE)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Mental health of the parents (PHQ)(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)(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)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Patient satisfaction (ZUF-8) Patient satisfaction(Change from 6 months after randomization at 12 and 18 months.)
- Elimination disorders of the chronically-ill children/adolescents (Anamnesebogen Enuresis/Funktionelle Harninkontinenz)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Treatment costs of the parents (CSSRI-DE)(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)(Change from baseline of the study at 6 months after the randomization)
- Treatment assessment (FBB-T)(Change from 6 months after randomization at 12 and 18 months.)
研究者
Silke Wiegand-Grefe, Prof. Dr.
Prof. Dr.
Universitätsklinikum Hamburg-Eppendorf