Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04382820
Status:
COMPLETED
Last Update Posted:
2021-12-09
First Post:
2020-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychosocial Situation of Children With Rare (Congenital) Pediatric Surgical Diseases and Their Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-27', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-08', 'lastUpdatePostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life of the parents (ULQIE)', 'timeFrame': '4 minutes', 'description': '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.'}, {'measure': 'Mental health of the parents (BSI)', 'timeFrame': '5 minutes', 'description': '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.'}, {'measure': 'Health-related quality of life of the chronically-ill children/adolescents (Peds-QL 4.0)', 'timeFrame': '4 minutes', 'description': '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.'}, {'measure': 'Psychiatric disorders of the chronically-ill children/adolescents and the siblings (SDQ)', 'timeFrame': '4 minutes', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Coping of the parents (CHIP-D)', 'timeFrame': '3 minutes', 'description': '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.'}, {'measure': 'Coping of the chronically-ill children/adolescents and the siblings (Kidcope)', 'timeFrame': '3 minutes', 'description': '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").'}, {'measure': 'Social support of the parents, of the chronically-ill children/adolescents and of the siblings (OSSS)', 'timeFrame': '3 minutes', 'description': '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.'}, {'measure': 'Sociodemographic information of the parents', 'timeFrame': '2 minutes', 'description': 'Sociodemographic information of the parents, assessed from the perspective of the parents by ad-hoc items.'}, {'measure': 'Relationships between siblings (SRQ)', 'timeFrame': '3 minutes', 'description': '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\n\n(1 to 5).'}, {'measure': 'Family relationships, family dynamics and functionality (FB-A)', 'timeFrame': '3 minutes', 'description': '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)'}, {'measure': 'Interpersonal problems (IIP-32)', 'timeFrame': '3 minutes', 'description': '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.'}, {'measure': 'Familial predispositions (FaBel)', 'timeFrame': '3 minutes', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rare diseases', 'pediatric surgery', 'children and adolescent', 'quality of life', 'psychological distress'], 'conditions': ['Rare Diseases']}, 'referencesModule': {'references': [{'pmid': '41341441', 'type': 'DERIVED', 'citation': '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': '34972234', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (families of rare disease):\n\n* Family with at least one child between 0 and 21 years with a rare pediatric surgical disease.\n* Consent to participate in the study.\n* Sufficient knowledge of the German language of parents and children.\n\nExclusion Criteria (families of rare disease):\n\n* 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.\n\nInclusion Criteria (control group):\n\n* 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\n* Consent to participate in the study.\n* Sufficient knowledge of the German language of parents and children.\n\nExclusion Criteria (control group):\n\n\\- Families of children with a congenital or chronic disease.'}, 'identificationModule': {'nctId': 'NCT04382820', 'briefTitle': 'Psychosocial Situation of Children With Rare (Congenital) Pediatric Surgical Diseases and Their Families', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Psychosocial Situation of Children With Rare (Congenital) Pediatric Surgical Diseases and Their Families', 'orgStudyIdInfo': {'id': 'PV7161'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Families of rare chronically ill children', 'description': '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.'}, {'label': 'Families in the comparative control group', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principial investigator', 'investigatorFullName': 'Johannes Boettcher', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}