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Clinical Trials/NCT04382820
NCT04382820
Completed
N/A

Psychosocial Situation of Children With Rare (Congenital) Pediatric Surgical Diseases and Their Families

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country167 target enrollmentApril 1, 2020
ConditionsRare Diseases

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rare Diseases
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
167
Locations
1
Primary Endpoint
Quality of life of the parents (ULQIE)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
April 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Johannes Boettcher

Principial investigator

Universitätsklinikum Hamburg-Eppendorf

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Quality of life of the parents (ULQIE)

Time Frame: 4 minutes

Quality of life (QoL) of the parents, assessed from the perspective of the parents by the "Ulmer Lebensqualitätsinventar für Eltern chronisch kranker Kinder" (ULQIE; Goldbeck \& Storck, 2002). The instrument consists of 29 items, which are answered on a five-point Likert scale (0 to 4). Higher scores indicate greater QoL.

Health-related quality of life of the chronically-ill children/adolescents (Peds-QL 4.0)

Time Frame: 4 minutes

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 "Pediatric Quality of Life Inventory 4.0" (Peds-QL 4.0; (Varni, Seid, \& Kurtin, 2001). Items will be linearly transformed to a scale of 0 to 100, with higher scores indicating better HRQoL.

Psychiatric disorders of the chronically-ill children/adolescents and the siblings (SDQ)

Time Frame: 4 minutes

Psychiatric disorders of the chronically-ill children/adolescents and the siblings assessed perspective of the child/adolescent (from 10 years of age) and from the perspective of the parents by the "Strengths and Difficulties Questionnaire" (SDQ; Klasen, Woerner, Rothenberger, \& Goodman, 2003). Items are rated on a three-point Likert scale (0 to 2). Higher scores represent greater psychopathology or greater prosocial behavior.

Mental health of the parents (BSI)

Time Frame: 5 minutes

Mental health of the parents, assessed from the perspective of the parents by the "Brief Symptom Inventory" (BSI; Franke, 2000). The instrument consists of 53 items, which are answered on a five-point Likert scale (0 to 4). Higher BSI scores indicate greater psychological distress.

Secondary Outcomes

  • Familial predispositions (FaBel)(3 minutes)
  • Interpersonal problems (IIP-32)(3 minutes)
  • Coping of the chronically-ill children/adolescents and the siblings (Kidcope)(3 minutes)
  • Coping of the parents (CHIP-D)(3 minutes)
  • Social support of the parents, of the chronically-ill children/adolescents and of the siblings (OSSS)(3 minutes)
  • Sociodemographic information of the parents(2 minutes)
  • Relationships between siblings (SRQ)(3 minutes)
  • Family relationships, family dynamics and functionality (FB-A)(3 minutes)

Study Sites (1)

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