Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-04 @ 7:13 PM
Study NCT ID:
NCT06528158
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Speech Groups for Children Living with a Sibling Who Suffers from Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Group ACCEPTABILITY', 'timeFrame': 'after attending group sessions, maximum 3 months after baseline', 'description': 'assess the clinical setting " sibling group "\'s acceptability among siblings of teenagers engaged in health care for AN. This will be assessed through the acceptability scale Abbreviated Acceptability Rating Profile (AARP) after attending group sessions.\n\nIn the questionnaire, there are 8 questions. For each, a scale of 1 to 6, with 1 being "not agreeing at all with the question" and 6 being "completely agree". Maximum score = 48 the higher the score, the better the acceptability of the group is felt by participants.'}], 'secondaryOutcomes': [{'measure': 'Impact of the groups on quality of life', 'timeFrame': 'baseline', 'description': 'THE PEDIATRIC QUALITY OF LIFE INVENTORY VERSION 4 (PEDSQLTM4.0) (MODULE GENERIC CORE SCALE) The PedsQL is a modular instrument for measuring health-related quality of life (HRQOL) in children and adolescents ages 2 to 18.\n\nThe PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules.\n\nThe PedsQL 4.0 Generic Core Scales consist of 23 items A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is us'}, {'measure': 'impact of the groups on quality of life', 'timeFrame': 'after attending group sessions, maximum 3 months after baseline', 'description': 'THE PEDIATRIC QUALITY OF LIFE INVENTORY VERSION 4 (PEDSQLTM4.0) (MODULE GENERIC CORE SCALE) The PedsQL is a modular instrument for measuring health-related quality of life (HRQOL) in children and adolescents ages 2 to 18.\n\nThe PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules.\n\nThe PedsQL 4.0 Generic Core Scales consist of 23 items A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is us'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['siblings', 'groups', 'children', 'teenagers', 'acceptability'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': "Anorexia nervosa (AN) is a complex mental disease with a huge impact on the patient's siblings life and well-being. Based on literature, group interventions for siblings of children suffering from a chronic disease could provide an effective support. A few have been studied, and even fewer exist for siblings of children with AN.", 'detailedDescription': "AN has a significant impact on nuclear family (parents and siblings). An emerging literature highlights the need for a particular attention to siblings. Despite this evidence, research and clinical applications still lack in this area. Indeed, most of health services in AN offer support for patients, family, parents, but only few specific support for siblings, although positive outcomes of sibling group interventions were reported in other somatic and psychic disabilities.\n\nNoting the gap between the need and the lack of specific support, the study hypothesis is that the poor diffusion of these interventions in AN might result from a low acceptability. The study propose to explore acceptability to adapt and improve group intervention for siblings of children and teenagers receiving care for anorexia nervosa.\n\nThe study is a mixed-method pilot study assessing the acceptability of a group intervention by including a maximum of 24 siblings of children suffering from AN, aged from 8 to 18, across three group sessions, each consisting of 4 meetings. All participants will be invited to fulfill two different auto-questionnaires about their quality of life (before and after group session) and the intervention's acceptability (after group session).\n\nQuantitative data will be complemented with qualitative data, collected from individual semi-structured interviews with a targeted sampling among group participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Maximum 24 participants will overall be included to attend group sessions. Around 15 participants will be invited to an individual interview after group sessions.', 'healthyVolunteers': False, 'eligibilityCriteria': '* inclusion criteria : Sibling presenting a DSM (Diagnostic and Statistical Manual)-5 of Mental Disorders diagnosis of AN, and engaged in inpatient or outpatient healthcare\n* exclusion criteria :\n\n * (1) Opposition from the participant and/or from their legal representatives.\n * (2) Non-fluent French speaker\n * (3) Clinical presentation not compatible with the group sessions'}, 'identificationModule': {'nctId': 'NCT06528158', 'acronym': 'EMA-FRaM', 'briefTitle': 'Speech Groups for Children Living with a Sibling Who Suffers from Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Sibling Group for Children and Teenagers Living with a Sibling Who Suffers from Anorexia Nervosa: a Pilot Acceptability Study', 'orgStudyIdInfo': {'id': 'RC31/24/0181'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sibling group', 'type': 'OTHER', 'description': 'The group will be based on a systemic model and led by two child psychiatrists trained in family and multi-family therapy, who will not subsequently be involved in the data analysis. It will consist of 4 sessions of 1h30, spread over a period of 2 months, with a maximum of 8 participants per session. The first 3 sessions will be spaced 15 days apart, and the last session will take place 3 weeks apart from the third session.\n\nThe characteristics of the group (frequency, duration, number of sessions and participants) were built on data from the literature as well as on clinical feedback from a first pilot group conducted in January and February 2024 on the Toulouse pediatric unit by the two therapists who will lead the groups during the study.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amélie Poinsard, MD RESIDENT', 'role': 'CONTACT', 'email': 'amelie.poinsard@free.fr', 'phone': '06.76.61.18.66'}], 'facility': 'UH Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Antoine STOCKER, MD', 'role': 'CONTACT', 'email': 'stocker.a@chu-toulouse.fr', 'phone': '05 61 77 22 33'}], 'overallOfficials': [{'name': 'Antoine STOCKER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}