Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-30 @ 2:27 AM
Study NCT ID:
NCT05857592
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2023-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving the Cognitive Accessibility of Self-reports for People With ID
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A mixed-method repeated-measures design will be used: data are collected using both qualitative and quantitative methods at two points in time (before and after adaptation) from the same participants.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scoring comprehension - T0', 'timeFrame': 'At baseline (T0)', 'description': 'Degree to which the qualitative information provided by the participant aligns with the self-reported score on the original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) questionnaire. Outcomes are 0, scores align, -1, scores are lower than answer would suggest, +1, score is higher than answer would suggest.'}, {'measure': 'Scoring comprehension - T1', 'timeFrame': 'Approximately 8 weeks after baseline (T1)', 'description': 'Degree to which the qualitative information provided by the participant aligns with the self-reported score on the original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) questionnaire. Outcomes are 0, scores align, -1, scores are lower than answer would suggest, +1, score is higher than answer would suggest.'}, {'measure': 'Text comprehension - cognitive interviews T0', 'timeFrame': 'At baseline (T0)', 'description': 'Level of verbal understanding of questions in the questionnaire - qualitative analysis of answers from cognitive interviews during assessment of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition). Terms and concepts that were misinterpreted, participant utterings of confusion of statements of difficulty'}, {'measure': 'Text comprehension - cognitive interviews T1', 'timeFrame': 'Approximately 8 weeks after baseline (T1)', 'description': 'Level of verbal understanding of questions in the questionnaire - qualitative analysis of answers from cognitive interviews during assessment of an adapted version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition). Terms and concepts that were misinterpreted, participant utterings of confusion of statements of difficulty.'}, {'measure': 'Comprehension of instructions - cognitive interviews T0', 'timeFrame': 'At baseline (T0)', 'description': 'Level of verbal understanding of the instructions in the questionnaire - original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition). Number of elements that were correctly identiefied (out of possible 10).'}, {'measure': 'Comprehension of instructions - cognitive interviews T1', 'timeFrame': 'Approximately 8 weeks after baseline (T1)', 'description': 'Level of verbal understanding of the instructions in the questionnaire - adapted version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition). Number of elements that were correctly identiefied (out of possible 10).'}, {'measure': 'Overall difficulty score - T0', 'timeFrame': 'At baseline (T0)', 'description': 'Likert scale rating of the overall difficulty of items of original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) by participants (from 1. very easy - 5. very difficult)'}, {'measure': 'Overall difficulty score - T1', 'timeFrame': 'Approximately 8 weeks after baseline (T1)', 'description': 'Likert scale rating of the overall difficulty of items of adapted version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) by participants (from 1. very easy - 5. very difficult)'}], 'secondaryOutcomes': [{'measure': 'Self-reported Adaptive Functioning - original ABAS-3 scores', 'timeFrame': 'At baseline (T0)', 'description': 'The ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) is an observational scale that measures adaptive behaviour. Both self-report and informant report versions are available. In the context of the current study, a 30-item abbreviated version is used. Composite scores are calculated: a total score and three domain scores (conceptual, social and practical domain). Scores range from 0-90 for the total scale and 0-30 for each domain scale. Higher scores indicate better adaptive functioning.'}, {'measure': 'Self-reported Adaptive Functioning - adapted ABAS-3 scores', 'timeFrame': 'Approximately 8 weeks after baseline (T1)', 'description': 'The ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) is an observational scale that measures adaptive behaviour. Both self-report and informant report versions are available. In the context of the current study, a 30-item abbreviated version is used. Composite scores are calculated: a total score and three domain scores (conceptual, social and practical domain). Scores range from 0-90 for the total scale and 0-30 for each domain scale. Higher scores indicate better adaptive functioning.\n\nThe second time participants complete the ABAS (approximately 8 weeks after baseline, T1), an adapted version is used, with language and design adapted to the comprehension level of participants according to the outcomes at baseline (T0).'}, {'measure': 'Informant-reported Adaptive Functioning - original ABAS-3 scores', 'timeFrame': 'At baseline (T0)', 'description': 'The ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) is an observational scale that measures adaptive behaviour. Both self-report and informant report versions are available. In the context of the current study, a 30-item abbreviated version is used. Composite scores are calculated: a total score and three domain scores (conceptual, social and practical domain). Scores range from 0-90 for the total scale and 0-30 for each domain scale. Higher scores indicate better adaptive functioning.\n\nFor the informant-report an adapted version of the original is used; the adaptations for the self-report version are replicated for the informant version.'}, {'measure': 'Informant-reported Adaptive Functioning - adapted ABAS-3 scores', 'timeFrame': 'Approximately 8 weeks after baseline (T1)', 'description': 'The ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) is an observational scale that measures adaptive behaviour. Both self-report and informant report versions are available. In the context of the current study, a 30-item abbreviated version is used. Composite scores are calculated: a total score and three domain scores (conceptual, social and practical domain). Scores range from 0-90 for the total scale and 0-30 for each domain scale. Higher scores indicate better adaptive functioning.\n\nFor the informant-report an adapted version of the original is used; the adaptations for the self-report version are replicated for the informant version.'}, {'measure': 'Self-reported Adaptive functioning - SCAF', 'timeFrame': 'At baseline (T0)', 'description': 'The SCAF (Screener for Adaptive Functioning) is a screening questionnaire for adaptive functioning for individuals who may have MID or BIF. The SCAF yields a total AF score (min 0 - max 24), with higher scores indicating better adaptive functioning.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['self-report questionnaires', 'inclusive diagnostics', 'easy-read language', 'adaptive functioning'], 'conditions': ['Mild Intellectual Disability', 'Borderline Intellectual Functioning']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Kooijmans, R., Mercera, G., Langdon, P. E., & Moonen, X. (2022). The adaptation of self-report measures to the needs of people with intellectual disabilities: A systematic review. Clinical Psychology: Science and Practice.'}]}, 'descriptionModule': {'briefSummary': "In the proposed study, the investigators aim to investigate whether the existing ABAS-3 self-report questionnaire is suitable to be completed meaningfully by individuals who are perceived as having mild intellectual disability (55\\<IQ\\<85) based on cognitive impairment. Based on the participants' experiences and researchers' expertise, the investigators develop a 'more inclusive' self-report version. The investigators then look at the extent to which participants indicate that they understand this version better, based on user experiences and limited psychometric research. In doing so, the investigators also compare the outcomes of the self-report and informant-report variant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Last known Total Intelligence Quotient (TIQ) 55 - 85\n* Receiving support from a care organization for persons with ID.\n* A care worker who knows the participant for at least a year and knows him well enough tot complete the informant version of the ABAS-3 is available.\n\nExclusion Criteria:\n\n• Severe physical or sensory impairment limiting ability to participate.'}, 'identificationModule': {'nctId': 'NCT05857592', 'briefTitle': 'Improving the Cognitive Accessibility of Self-reports for People With ID', 'organization': {'class': 'OTHER', 'fullName': 'Koraal'}, 'officialTitle': 'Adapting Self-report Instruments for People With Intellectual Disability to Improve Cognitive Accessibility - Putting Guidelines to the Test', 'orgStudyIdInfo': {'id': 'Koraal-ABAS-Kooijmans'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Persons with Mild Intellectual Disability (MID) or Borderline Intellectual Functioning (BIF) complete the ABAS-3 in assisted form on two occasions: the original version the first time and an adapted version after a few weeks.', 'interventionNames': ['Diagnostic Test: Adaptive functioning self-report questionnaire', 'Diagnostic Test: Adaptive functioning self-report questionnaire - adapted']}], 'interventions': [{'name': 'Adaptive functioning self-report questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'A self-report questionnaire for assessing level of adaptive functioning', 'armGroupLabels': ['Experimental']}, {'name': 'Adaptive functioning self-report questionnaire - adapted', 'type': 'DIAGNOSTIC_TEST', 'description': 'A self-report questionnaire for assessing level of adaptive functioning, adapted to the communication level of the participant', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6130 PC', 'city': 'Sittard', 'state': 'L', 'country': 'Netherlands', 'facility': 'Koraal', 'geoPoint': {'lat': 50.99833, 'lon': 5.86944}}], 'overallOfficials': [{'name': 'Roel Kooijmans, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Koraal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study data are highly specific for this study and not relevant for sharing with other researchers, except for validation of results in exceptional circumstances. When required, relevant data will be made available upon request to reviewers or auditors, subject to privacy regulations. Only anonymized data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koraal', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Amsterdam', 'class': 'OTHER'}, {'name': 'Zuyd University of Applied Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Roel Kooijmans', 'investigatorAffiliation': 'Koraal'}}}}