Clinical trial NCT04382820: Psychosocial Situation of Children With Rare (Congenital) Pediatric Surgical Diseases and Their Families
Official title: Psychosocial Situation of Children With Rare (Congenital) Pediatric Surgical Diseases and Their Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rare Diseases
Keywords: rare diseases
pediatric surgery
children and adolescent
quality of life
psychological distress
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 167
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical study participants for the diagnostic study are patients who have sought treatment at the University Medical Center Hamburg-Eppendorf due to a rare pediatric surgical disease. Participants in the healthy control sample are matched to the clinical sample in terms of age and gender. Included are families of children aged 0-21 years, who have undergone a surgical procedure at the University Medical Center Hamburg-Eppendorfin the first 3 years of life that does not cause chronic complaints; such as hernia surgery or testicular relocation.

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 aim of the present research project is to examine the psychosocial burden of the children with rare (congenital) pediatric surgical diseases and their family in order to draw attention to a possible psychosocial care gap in this population.

Detailed description: The central objective of the cross-sectional study is to show the psychosocial supply gap for families with children and adolescents affected by rare diseases in the field of pediatric surgery. Among the rare diseases that are included are diaphragmatic hernia, anorectal malformations, esophageal atresia, Hirschsprung's disease and biliary atresia. In order to have a comparative sample, additional data of a matched control group are collected. Central standardized psychosocial outcomes will be assessed from the perspectives of the parents, the affected child and the siblings.

Eligibility criteria: Inclusion Criteria (families of rare disease):

* Family with at least one child between 0 and 21 years with a rare pediatric surgical disease.
* Consent to participate in the study.
* Sufficient knowledge of the German language of parents and children.

Exclusion Criteria (families of rare disease):

* Severe acute physical, mental and/or cognitive impairment of the child, so that the questionnaire survey does not appear possible and/or unreasonable at this stage.

Inclusion Criteria (control group):

* Family with at least one child between 0 and 21 years who have undergone a surgical procedure in the first 3 years of life that does not cause chronic complaints
* Consent to participate in the study.
* Sufficient knowledge of the German language of parents and children.

Exclusion Criteria (control group):

- Families of children with a congenital or chronic disease.

Primary outcomes:
measure: Quality of life of the parents (ULQIE)
timeFrame: 4 minutes
measure: Mental health of the parents (BSI)
timeFrame: 5 minutes
measure: Health-related quality of life of the chronically-ill children/adolescents (Peds-QL 4.0)
timeFrame: 4 minutes
measure: Psychiatric disorders of the chronically-ill children/adolescents and the siblings (SDQ)
timeFrame: 4 minutes
Secondary outcomes:
measure: Coping of the parents (CHIP-D)
timeFrame: 3 minutes
measure: Coping of the chronically-ill children/adolescents and the siblings (Kidcope)
timeFrame: 3 minutes
measure: Social support of the parents, of the chronically-ill children/adolescents and of the siblings (OSSS)
timeFrame: 3 minutes
measure: Sociodemographic information of the parents
timeFrame: 2 minutes
measure: Relationships between siblings (SRQ)
timeFrame: 3 minutes
measure: Family relationships, family dynamics and functionality (FB-A)
timeFrame: 3 minutes
measure: Interpersonal problems (IIP-32)
timeFrame: 3 minutes
measure: Familial predispositions (FaBel)
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References:
citation: Boettcher J, Nazarian R, Fuerboeter M, Liedtke A, Wiegand-Grefe S, Reinshagen K, Boettcher M. Mental Health of Siblings of Children with Rare Congenital Surgical Diseases during the COVID-19 Pandemic. Eur J Pediatr Surg. 2022 Oct;32(5):422-428. doi: 10.1055/s-0041-1740978. Epub 2021 Dec 31.