Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT04416360
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2020-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder in Covid-19 Outbreak
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interview of the parents : contextual data', 'timeFrame': 'Baseline', 'description': "composition, home confinement, change in the environment, personal room at home, screens with internet access, parents' current professional status, teleworking, care, family concerns related to Covid-19, parenting stress, schooling, recurrent complaints."}, {'measure': 'Interview of the children/adolescents/ parents : Experience of the confinement in general', 'timeFrame': 'Baseline', 'description': 'related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)'}, {'measure': 'Interview of the children/adolescents/ parents : Experience of the confinement in general', 'timeFrame': '1 month', 'description': 'related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)'}, {'measure': 'Interview of the children/adolescents/ parents : Experience of the confinement in general', 'timeFrame': '3 months', 'description': 'related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)'}, {'measure': 'Interview of the referring caregiver : data relating to disease and management of care', 'timeFrame': '3 months', 'description': 'Data relating to disease and management of care. Experience of the referring caregiver.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['home confinement', 'Covid-19', 'qualitative research', 'Autism Spectrum Disorder', 'Attention-deficit Hyperactivity Disorder'], 'conditions': ['Autism Spectrum Disorder', 'Attention-deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': "In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders. These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.).", 'detailedDescription': 'Children with Autism Spectrum Disorder (ASD) and/or hyperactive children (ADHD) usually have behavioral and emotional difficulties. The disorders they suffer from, which considerably disturb family life, the therapies they benefit from, which help to organize and structure their daily lives, make them a coherent study group whose observation during home confinement is particularly relevant. Therefore, it is especially interesting to explore the impact of quarantine on the evolution of clinical symptoms and family dynamic.\n\nThere is little evidence about the impact of prolonged confinement in these children. The first clinical observations, at the beginning of confinement, reported various situations. Some children showed marked emotional disturbances, whereas others seem to be happy with less social pressure. For ASDs, the ritualization can be a stabilizing factor. For ADHDs, the decrease in school pressure is undoubtedly a positive factor. The availability of parents to create a suitable environment could play a major role. In all cases, changes in care management (teleconsultations for most of them), disruption in routines and lack of points of reference, adjustment in parenting and caring for children for the parents (with difficulties that could increase with prolonged duration of confinement), could have serious long-term effects, but also create opportunities.\n\nSo, the present study aim to document the experience of home confinement in children and adolescents with ASD and/or ADHD quarantined because of covid-19 outbreak in various socio-cultural contexts. The experiences reported by the children, their parents and their caregivers will help understand the psychological impact of quarantine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "1. Inclusion Criteria:\n\n Children / adolescents:\n * autism spectrum disorder (ASD) w/wo co-morbidities and/or attention-deficit - hyperactivity disorder (ADHD)\n * aged 6 to 17 years (developmental age)\n * cared by child psychiatry services involved in the study with continuing care (teleconsultations) during home confinement\n * at least one parent consent to participate in the study\n * child benefiting from a social security\n\n Parents: one or both parents depending on availability and confinement configurations (childcare)\n\n Referring caregivers: the referring caregiver will be identified at the time of the child's inclusion in the study\n2. Exclusion Criteria:\n\n * Parents subject to a judicial safeguard order, guardianship or trusteeship\n * Parents or children/adolescents who refuse to participate\n * Parents unable to comply with the study requirements because of language or because of lack of access to visio or telephone conference facilities"}, 'identificationModule': {'nctId': 'NCT04416360', 'acronym': 'CLIECO', 'briefTitle': 'Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder in Covid-19 Outbreak', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak', 'orgStudyIdInfo': {'id': 'RC31/20/0151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interview by psychologists', 'description': 'Children and adolescent interview Parents interview Referring caregiver interview', 'interventionNames': ['Other: Interview by psychologists']}], 'interventions': [{'name': 'Interview by psychologists', 'type': 'OTHER', 'description': 'Interviews for children / teenagers and parents :\n\n* The questions encourage a narrative\n* Repeated interviews: during confinement, at the end of confinement, and 3 months after the end of confinement\n* Interviews carried out by videoconference, by trained psychologists not involved in the care process\n\nInterview for referring caregivers: a single interview of approximately 45 minutes, 3 months post-confinement', 'armGroupLabels': ['Interview by psychologists']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'state': 'Occitanie', 'country': 'France', 'facility': 'University hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '78157', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Centre Hospitalier de Versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '87025', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospitalier Esquirol', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert-Debré (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Maison de Solenn (Hôpital Cochin AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Malika DELOBEL-AYOUB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}