Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 1:41 PM
Study NCT ID:
NCT04714606
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2020-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-29', 'releaseDate': '2024-12-18'}], 'estimatedResultsFirstSubmitDate': '2024-12-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2020-12-09', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Strengths & Difficulties Questionnaire (SDQ, Goodman et al., 2009) scores', 'timeFrame': 'Pre (Week 1) and post (Week 6) intervention', 'description': 'Questionnaire used to measure effectiveness pre and post intervention or control condition. Lower scores indicate better outcome.'}, {'measure': 'Change in Paediatric Quality of Life Inventory (PedsQL V4.0; Varni, Seid & Kurtin, 2001) scores', 'timeFrame': 'Pre (Week 1) and post (Week 6) intervention', 'description': 'Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.'}, {'measure': 'Change in Knowledge of Autism Questionnaire (KAS; Ross & Cuskelly, 2006) scores', 'timeFrame': 'Pre (Week 1) and post (Week 6) intervention', 'description': 'Questionnaire used to measure knowledge of autism pre and post intervention or control condition. Higher scores indicate better outcome.'}, {'measure': 'Change in Goal Based Outcomes (GBOs, Law & Jacob, 2015) scores Goal Based Outcomes (GBOs, Law & Jacob, 2015)', 'timeFrame': 'Pre (Week 1) and post (Week 6) intervention', 'description': 'Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.'}], 'secondaryOutcomes': [{'measure': 'Experience of Service Questionnaire (ESQ, Attride-Stirling, 2002)', 'timeFrame': 'Post intervention (6 weeks after Time 1)', 'description': 'Questionnaire used to measure experience post intervention or control condition. Higher scores indicate better outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'A feasibility controlled trial of an eight-session group intervention for siblings of children who have an Autism Spectrum Disorder (ASD).\n\nChildren will be recruited from a multi-academy trust of nine schools. Due to the on-going impact of COVID-19 restrictions, children will be allocated to the intervention condition (eight session support group) if they are physically attending school and to the control condition (receipt of a booklet) if they remain at home. Pre and post outcome measures will be completed by children and their parents in both research arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 7-11 years old.\n2. Must have a sibling who has a formal diagnosis of ASD.\n3. Must be competent in the English language.\n4. Must be in mainstream education.\n5. Must be willing and able to engage in an eight-session group intervention (including being accompanied to and from the group by their parents/carers).\n6. Must be registered with a GP and parental consent gained to inform the GP that the sibling is attending the group.\n\nExclusion Criteria:\n\n1. If the sibling has a diagnosis of ASD themselves.\n2. If there are any clear risk concerns (e.g. any thought or intent to harm self or others, involvement in court proceedings or with the criminal justice system).\n3. If the sibling is currently receiving any other psychological treatment.\n4. If the sibling has a learning disability or difficulty that will make it hard to access the group content and/or capacity to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT04714606', 'briefTitle': 'Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD', 'organization': {'class': 'OTHER', 'fullName': 'University of Surrey'}, 'officialTitle': 'Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD', 'orgStudyIdInfo': {'id': '260159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sibling support group', 'description': '8 session, tailored support group for siblings of children who have an ASD', 'interventionNames': ['Other: Sibling support group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Booklet', 'description': 'Control condition in which siblings of children who have an ASD will receive a tailored booklet to complete at home', 'interventionNames': ['Other: None - control condition']}], 'interventions': [{'name': 'Sibling support group', 'type': 'OTHER', 'description': 'The intervention is a novel, 8 session sibling support group which has been created for the purpose of the study.', 'armGroupLabels': ['Sibling support group']}, {'name': 'None - control condition', 'type': 'OTHER', 'description': 'The second arm of the study is a control condition in which participants will be given a tailored booklet to complete at home as it was deemed unethical to provide them with nothing.', 'armGroupLabels': ['Booklet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KT24 5JR', 'city': 'Leatherhead', 'country': 'United Kingdom', 'facility': 'The Howard Partnership Multi-Academy Trust', 'geoPoint': {'lat': 51.29652, 'lon': -0.3338}}], 'overallOfficials': [{'name': 'Lucy Ms Watson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Surrey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Surrey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-12-18', 'type': 'RELEASE'}, {'date': '2025-01-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Surrey'}}}}