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

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

Tracking Information

• First Submitted Date: May 4, 2020
• First Posted Date: May 11, 2020
• Last Update Posted Date: May 11, 2020
• Actual Study Start Date: April 1, 2020
• Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 8, 2020)

• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 8, 2020)

• 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.
• 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").
• 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.
• 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.
• 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).
• 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)
• 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.
• 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Control; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 1 Month
• Biospecimen: Not Provided
• 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.
• Condition: Rare Diseases
• Intervention: Not Provided

Study Groups/Cohorts

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 8, 2020): 170
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2020
• Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 21 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT04382820
• Other Study ID Numbers: PV7161
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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.

• Responsible Party: Dr. med. Michael Boettcher, Universitätsklinikum Hamburg-Eppendorf
• Study Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universitätsklinikum Hamburg-Eppendorf
• Verification Date: May 2020