Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05107518
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2021-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Children Participation Assessment Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Children Participation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Children Participation Assessment Scale', 'timeFrame': '6-12 years', 'description': 'Children Participation Assessment scale is an assessment tool that includes all work-occupation areas (daily life and activities, play, leisure time, social participation, work, sleep/rest). Children Participation Assessment Scale, used in children aged 6-12 It has two versions, child and parent version.'}], 'secondaryOutcomes': [{'measure': 'Child Health Questionnaire', 'timeFrame': '5-18 years', 'description': 'he Child Health Questionnaire (CHQ) is a generic health instrument designed to capture the physical and psychosocial well-being of children independently from the underlying disease.he purpose of the instrument is to evaluate the functional health and well-being of children aged 5-18 years via parent-proxy report.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child development', 'children participation', 'validity', 'version'], 'conditions': ['Child Development', 'Physical Disability', 'Participation, Patient']}, 'referencesModule': {'references': [{'pmid': '29039716', 'type': 'BACKGROUND', 'citation': 'Amini M, Hassani Mehraban A, Rostamzadeh O, Mehdizadeh F. Psychometric Properties of the Iranian-Children Participation Questionnaire (I-CPQ) When Used with Parents of Preschool Children with Cerebral Palsy. Occup Ther Health Care. 2017 Oct;31(4):341-351. doi: 10.1080/07380577.2017.1382753. Epub 2017 Oct 17.'}, {'pmid': '30697766', 'type': 'BACKGROUND', 'citation': 'Amini M, Hassani Mehraban A, Pashmdarfard M, Cheraghifard M. Reliability and validity of the Children Participation Assessment Scale in Activities Outside of School-Parent version for children with physical disabilities. Aust Occup Ther J. 2019 Aug;66(4):482-489. doi: 10.1111/1440-1630.12569. Epub 2019 Jan 30.'}, {'pmid': '16110940', 'type': 'BACKGROUND', 'citation': 'Parsons SK, Shih MC, Mayer DK, Barlow SE, Supran SE, Levy SL, Greenfield S, Kaplan SH. Preliminary psychometric evaluation of the Child Health Ratings Inventory (CHRIs) and Disease-Specific Impairment Inventory-Hematopoietic Stem Cell Transplantation (DSII-HSCT) in parents and children. Qual Life Res. 2005 Aug;14(6):1613-25. doi: 10.1007/s11136-005-1004-2.'}]}, 'descriptionModule': {'briefSummary': 'Increasing the number of Turkish versions of questionnaires evaluating participation will increase the variety of assessment methods. This study aims to evaluate the Turkish version, validity and reliability of the Children Participation Assessment Scale.', 'detailedDescription': 'This study was designed to examine the validity and reliability of the Turkish version of the Children Participation Assessment Scale. Translation and cultural adaptation of the questionnaire will be designed according to an appropriate procedure. The original English version of the questionnaire is fluent in English; It will be translated into Turkish by two people, one a physiotherapist and the other a linguist. Translators will come together and combine the questionnaires translated into Turkish into a single translation. The questionnaire translated into Turkish will then be translated back into English by two sworn translators whose mother tongue is English and who know Turkish well. The questionnaire, which was translated from Turkish to English again, will be synthesized by the translation team and turned into a single translation and its compatibility with the original will be evaluated. 250 children between the ages of 6 and 12 with physical disabilities and their parents will be included in this study. Children and parents with serious visual and auditory problems and who do not volunteer to participate in the study will be excluded from the study. While examining the validity of the scale in children, it was planned to use the Child Health Questionnaire scale, which had previously been shown to be reliable and valid in healthy children with different disability levels. The questions in the data collection form will be asked to the parents in the form of face-to-face interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '250 children aged 6-12 with physical disabilities and their parents will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6-12 years old\n* physically disability\n* adequate cognitive level\n\nExclusion Criteria:\n\n* severe visual or auditory problems\n* children and parents who did not volunteer to participate in the study'}, 'identificationModule': {'nctId': 'NCT05107518', 'briefTitle': 'Children Participation Assessment Scale', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Turkish Version, Validity and Reliability Study of the "Children Participation Assessment Scale"', 'orgStudyIdInfo': {'id': 'Children Participation'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'children with physical disabilities', 'description': 'his study was designed to examine the validity and reliability of the Turkish version of the Children Participation Assessment Scale. While examining the validity of the scale in children, it was planned to use the Child Health Questionnaire-(CSA) scale, which had previously been shown to be reliable and valid in healthy children with different disability levels.', 'interventionNames': ['Behavioral: Children Participation Assessment Scale']}], 'interventions': [{'name': 'Children Participation Assessment Scale', 'type': 'BEHAVIORAL', 'otherNames': ['Child Health Questionnaire scale'], 'description': 'Evaluation is carried out to examine the validity and reliability of the Turkish version of the Children Participation Assessment Scale. While examining the validity of the scale in children, it was planned to use the Child Health Questionnaire scale, which had previously been shown to be reliable and valid in healthy children with different disability levels.', 'armGroupLabels': ['children with physical disabilities']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'yenimahalle', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'rabia eraslan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Rabia ZORLULAR', 'investigatorAffiliation': 'Gazi University'}}}}