Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-03-29 @ 5:14 PM
Study NCT ID:
NCT02676232
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2016-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2016-01-28', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '2 weeks after intervention', 'description': 'Assessed with the abdominal Pain Index'}, {'measure': 'Pain Frequency', 'timeFrame': '2 weeks after intervention', 'description': 'Assessed with the abdominal Pain Index'}, {'measure': 'Pain Intensity', 'timeFrame': '6 months after the intervention', 'description': 'Assessed with the abdominal Pain Index'}, {'measure': 'Pain Intensity', 'timeFrame': '12 months after the intervention', 'description': 'Assessed with the abdominal Pain Index'}, {'measure': 'Pain Frequency', 'timeFrame': '6 months after the intervention', 'description': 'Assessed with the abdominal Pain Index'}, {'measure': 'Pain Frequency', 'timeFrame': '12 months after the intervention', 'description': 'Assessed with the abdominal Pain Index'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '2 weeks after intervention; 6 and 12 months.', 'description': 'Assessed with the Pediatric Quality of Life Inventory'}, {'measure': 'Disability', 'timeFrame': '2 weeks after intervention; 6 and 12 months.', 'description': 'Assessed with the Functional Disability Inventory'}, {'measure': 'Depression', 'timeFrame': '2 weeks after intervention; 6 and 12 months.', 'description': 'Assessed with the Children Depression Inventory.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Online Intervention', 'Recurrent Abdominal Pain', 'Children'], 'conditions': ['Abdominal Pain']}, 'referencesModule': {'references': [{'pmid': '25551478', 'type': 'BACKGROUND', 'citation': 'Nieto R, Hernandez E, Boixados M, Huguet A, Beneitez I, McGrath P. Testing the Feasibility of DARWeb: An Online Intervention for Children With Functional Abdominal Pain and Their Parents. Clin J Pain. 2015 Jun;31(6):493-503. doi: 10.1097/AJP.0000000000000199.'}], 'seeAlsoLinks': [{'url': 'http://psinet.uoc.edu/courses/darweb/?lang=en', 'label': 'Research team website'}]}, 'descriptionModule': {'briefSummary': 'Chronic and recurrent pain is a very important issue in the society, and its treatment is challenging.\n\nIn children, one of the most common pain problems is recurrent abdominal pain. This problem can affect up to 12% of the children population, and can interfere on daily activities of both children and parents. Recurrent abdominal pain in children is also associated with other health problems, and can be related to problems in adulthood. Unfortunately, the current health system does not have an effective treatment for these children and their families. This is why the investigators propose an online intervention, DARWeb, for people in this situation.\n\nDARWeb provides an innovative solution using Information and Communication Technology to facilitate access. It is also innovative because it is directed towards secondary prevention, in contrast to the majority of current treatments available for pain problems that are focused in reducing the impact of pain when it is already severe. Thus, the objective of DARWeb is to provide information and teach strategies to children and their parents that help them to cope with pain and prevent pain interference in their daily lives (in the short, medium and long term).\n\nWith this project, the investigators plan, first, to create a new version of their treatment program (DARWeb V2) from the results of the pilot study. Second, the investigators will test the effects of DARWeb V2 through a randomized clinical trial with a large sample, and they will assess the short, medium and long term effects. In addition, the investigators want to study which of the variables that are addressed in their intervention are responsible for the potential changes observed.\n\nThe investigators expect that their treatment program will be effective to reduce pain in the short, medium and long term.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 9 to 15 years\n* Recurrent abdominal pain (abdominal pain at least once at month during a period of three months)\n* Low level of disability\n\nExclusion Criteria:\n\n* Identifiable organic cause.\n* Disability preventing them to follow an online intervention.\n* Not having a computer with Internet access.\n* Not being able to read in Spanish language.'}, 'identificationModule': {'nctId': 'NCT02676232', 'briefTitle': 'DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Oberta de Catalunya'}, 'officialTitle': 'DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.', 'orgStudyIdInfo': {'id': 'R464E'}, 'secondaryIdInfos': [{'id': 'PSI2013-42413-R', 'type': 'OTHER_GRANT', 'domain': 'Ministerio de Economía y Competitividad'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants in this arm will follow DARWeb: an online psychosocial intervention for children with recurrent abdominal pain and their parents. This is composed by 7 units for parents and 7 units for children, that have been developed from the cognitive-behavioral model, including setting goals, relaxation and distraction techniques, changing maladaptive thoughts and assertive communication training. The team under the program only contact with families for sending reminders and to answer potential technical problems or doubts', 'interventionNames': ['Behavioral: DARWeb']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants allocated in this arm will not receive intervention. However, they will be invited to participate once the families allocated to the experimental group complete the program.'}], 'interventions': [{'name': 'DARWeb', 'type': 'BEHAVIORAL', 'description': 'Psychosocial Intervention from the cognitive-behavioral model, including different but related units for parents and children with recurrent abdominal pain.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08018', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Universitat Oberta de Catalunya', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Rubén Nieto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat Oberta de Catalunya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Oberta de Catalunya', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministerio de Economía y Competitividad, Spain', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rubén Nieto Luna, PhD', 'investigatorFullName': 'Rubén Nieto', 'investigatorAffiliation': 'Universitat Oberta de Catalunya'}}}}