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

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ClinicalTrials.gov Identifier: NCT04382820
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. med. Michael Boettcher, Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.

Condition or disease
Rare Diseases

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 170 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: Psychosocial Situation of Children With Rare (Congenital) Pediatric Surgical Diseases and Their Families
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rare Diseases

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Coping of the parents (CHIP-D) [ Time Frame: 3 minutes ]
    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). Items are rated on a four-point Likert scale (0 to 3). Higher scores represent greater use of the respective coping pattern.

  2. Coping of the chronically-ill children/adolescents and the siblings (Kidcope) [ Time Frame: 3 minutes ]
    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). Items related to frequency of the coping strategies are rated on a 4 point scale (0 = "Not at all" to 3 = "Almost all the time"), and items related to efficacy are rated on a 5 point scale (0 = "Not at all" to 4 = "Very much").

  3. Social support of the parents, of the chronically-ill children/adolescents and of the siblings (OSSS) [ Time Frame: 3 minutes ]
    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 Scale" (OSSS; Dalgard, 2006). The sum score ranges from 3 to 14. The higher the sum score, the stronger the social support.

  4. Sociodemographic information of the parents [ Time Frame: 2 minutes ]
    Sociodemographic information of the parents, assessed from the perspective of the parents by ad-hoc items.

  5. Relationships between siblings (SRQ) [ Time Frame: 3 minutes ]

    Sibling relationship, assessed from the perspective of the siblings (from 10 years of age) by the "Sibling Relationship Questionnaire" (Bojanowski, Riestock, Nisslein, Weschenfelder-Stachwitz, & Lehmkuhl, 2015). Each item is scored on a 5-point Likert scale

    (1 to 5).


  6. Family relationships, family dynamics and functionality (FB-A) [ Time Frame: 3 minutes ]
    Family relationships, family dynamics and functionality, assessed from the perspective of the parents, of the chronically-ill children/adolescents and from the sibling, respectively by "Familienbögen" (FB-A; Cierpka & Frevert, 1994). Items are rated on a four-point Likert scale (0 to 3)

  7. Interpersonal problems (IIP-32) [ Time Frame: 3 minutes ]
    Interpersonal problems assessed from the perspective of the parents by the "Inventory of Interpersonal Problems-32" (IIP-32; Thomas, Brähler, & Strauß, 2011). Items are rated on a four-point Likert scale from 0 (not at all) to 4 (extremely). It provides an overall score and eight subscale scores.

  8. Familial predispositions (FaBel) [ Time Frame: 3 minutes ]
    familial predispositions assessed from the perspective of the parents by the "Familien-Belastungs-Fragebogen" (FaBel; Ravens-Sieberer, 2001). Items are rated on a four-point Likert scale ranging from 1 (is not right at all) to 4 (is completely right).


Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382820


Contacts
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Contact: Michael Boettcher, PD Dr. med. +49- 40- 7410-52717 m.boettcher@uke.de
Contact: Johannes Boettcher, Dipl.-Psych. +49- 40- 7410-24155 j.boettcher@uke.de

Locations
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Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Michael C Boettcher, M.D.    +4915222815153    m.boettcher@uke.de   
Contact    +4915222815153    m.boettcher@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
More Information
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Responsible Party: Dr. med. Michael Boettcher, Principial investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04382820    
Other Study ID Numbers: PV7161
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med. Michael Boettcher, Universitätsklinikum Hamburg-Eppendorf:
rare diseases
pediatric surgery
children and adolescent
quality of life
psychological distress
Additional relevant MeSH terms:
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Rare Diseases
Disease Attributes
Pathologic Processes