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

NCT04382820 | Completed

• 1 other identifier: PV7161
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Rare Diseases

Keywords

rare diseases; pediatric surgery; children and adolescent; quality of life; psychological distress

Outcome Measures

Primary Outcomes (4)

• Quality of life of the parents (ULQIE)

  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.

  4 minutes

• 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). 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.

  5 minutes

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

  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.

  4 minutes

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

  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.

  4 minutes

Secondary Outcomes (8)

• Coping of the parents (CHIP-D)

  3 minutes

• Coping of the chronically-ill children/adolescents and the siblings (Kidcope)

  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

Study Arms (2)

Families of rare chronically ill children

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. Every family receives a comprehensive psychosocial diagnostic in the form of standardized instruments.

Families in the comparative control group

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 in the first 3 years of life that does not cause chronic complaints; such as hernia surgery or testicular relocation.

Eligibility Criteria

• Age: 1 Day - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• \- Families of children with a congenital or chronic disease.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (2)

• Boettcher J, Hohmann S, Daubmann A, Denecke J, Muntau AC, Wiegand-Grefe S, Zapf H. The Family Stress Model in families of children with rare diseases: a cross-sectional multilevel path analysis for understanding family dynamics. Front Public Health. 2025 Nov 18;13:1713613. doi: 10.3389/fpubh.2025.1713613. eCollection 2025.

  PMID: 41341441 DERIVED

• 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.

  PMID: 34972234 DERIVED

MeSH Terms

Conditions

Rare Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial investigator

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 11, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

DE (1)