Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-06 @ 10:46 PM
Study NCT ID:
NCT03141333
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2017-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Teleintervention in Developmental Coordination Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019957', 'term': 'Motor Skills Disorders'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Utilization of the teleintervention', 'timeFrame': '3 months (from day 1 to study completion)', 'description': 'Time spent on the web plate-form (calculated in minutes, time spent on the plate-form during the 3 months teleintervention)'}], 'secondaryOutcomes': [{'measure': 'Recruitment and retention', 'timeFrame': 'Number of participants at baseline and at completion of the study (3 months later)', 'description': 'Number of participants recruited and retention rate'}, {'measure': "Parents' sense of competencies", 'timeFrame': 'Collected at baseline and at completion of the study (3 months later)', 'description': 'Parenting Sense of Competence Scale'}, {'measure': "Parents' satisfaction with the intervention", 'timeFrame': 'At completion of the study (3 months following the begining of the teleintervention)', 'description': 'Qualitative interviews'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Developmental Coordination Disorder']}, 'descriptionModule': {'briefSummary': "The principal study goals are to determine if a randomized control trial would be feasible, particularly with regards to i) recruitment and retention of parents of children having a diagnosis or a suspicion of diagnosis of DCD, and ii) parents' utilization of the teleintervention. The study will also examine quantitatively and qualitatively families' acceptability of- and satisfaction with the teleintervention.", 'detailedDescription': "Developmental coordination disorder (DCD) is a neurodevelopmental disorder characterised by difficulties in planning and execution of motor coordination activities like dressing, sports and writing. Increasing parents' capacity to manage their children's needs is part of the recommended DCD best practices, as soon as children are suspected to have DCD or early following diagnosis. Parents' capacity could be increased through simple, community-based interventions using a consultative approach. Using the Internet could be an interesting avenue to develop public community-based services and build parents' capacity to manage their child with DCD. The feasibility of recruiting and using the Internet to build parents' capacity is however unknown, since no such study have been conducted.\n\nThis randomized feasibility trail will experiment a teleintervention, characterized by a virtual interaction between a health professional and a user by Internet, for children with DCD. The principal study goals are to determine if a randomized control trial would be feasible, particularly with regards to i) recruitment and retention of parents of children having a diagnosis or a suspicion of diagnosis of DCD, and ii) parents' utilization of the teleintervention. The study will also examine quantitatively and qualitatively families' acceptability of- and satisfaction with the teleintervention. As part of the evaluation of acceptability, the impact of the teleintervention on parental competencies will be explored. At the end of the 3-months randomized feasibility trial, the influence of the number of participants on the utilization of the teleintervention will be explored by providing access to the teleintervention to all participants (control and intervention)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A DCD medical diagnostic (or DCD medical hypothesis)\n* Must be at or under the 16e percentile for the global score at the Movement Assessment Battery for Children-2 (MABC-2) or be at or under the 5e for one of the 3 subscale of the MABC-2.\n\nExclusion Criteria:\n\n* Do not have other neurodevelopmental diagnoses, with the exception of Attention Deficit Hyperactivity Disorder (ADHD)\n* Do not receive rehabilitation services for DCD in the public health care system'}, 'identificationModule': {'nctId': 'NCT03141333', 'acronym': 'DCD', 'briefTitle': 'A Teleintervention in Developmental Coordination Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'A Randomized Feasibility Trial Evaluating a Teleintervention for Families of Children With Developmental Coordination Disorder (DCD)', 'orgStudyIdInfo': {'id': 'usherbrooke'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teleintervention', 'description': 'Participants of this group will have access to the following sections in the web plate-form: information, forum, chat and live online consultation. The teleintervention consists of having access to the forum, chat and live online consultation sections of the web plate-form.', 'interventionNames': ['Behavioral: Teleintervention']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Participants of this group will have access to the following section of the web plate-form: information, which is consistent with the standard of care for many families of children with DCD, who only have access to online information but do not have access to any type of intervention.'}], 'interventions': [{'name': 'Teleintervention', 'type': 'BEHAVIORAL', 'description': 'Participants of this group will have access to the following sections in the web plate-form: information, forum, chat and live online consultation. The teleintervention consists of having access to the forum, chat and live online consultation sections of the web plate-form.', 'armGroupLabels': ['Teleintervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1E 3A4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CR CHUS', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Chantal Camden', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CR CHUS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}