Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT04130360
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2019-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of an Online Problem-solving Intervention for Aggression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000374', 'term': 'Aggression'}], 'ancestors': [{'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants are not told that they are being randomised or that they are participating in an intervention trial until they complete the follow-up. Randomisation is computerized and participants have no contact with a care provider or an investigator.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention and control group. Participants are randomised to one of them.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 908}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-19', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aggression (trait)', 'timeFrame': '1 month', 'description': 'Aggression Questionnaire (AQ): Physical Aggression, Verbal Aggression, Hostility, Anger. Each item is responded from 1 (extrememly uncharacteristic of me) to 5 (extremely characteristic of me), with higher scores meaning higher aggression.'}, {'measure': 'Aggression (frequency)', 'timeFrame': '1 month', 'description': 'Physical and relational aggression questionnaire. Each item is responded from 1 (never) to 5 (5 or more times), with higher scores meaning higher aggression.'}], 'secondaryOutcomes': [{'measure': 'Problem-solving skills', 'timeFrame': '1 month', 'description': 'Problem Solving Skills (PSI-PSS). Each item is responded from 1 (strongly disagree) to 6 (strongly agree), with higher scores meaning higher problem-solving skills.'}, {'measure': 'Problem-solving self-efficacy', 'timeFrame': '1 month', 'description': 'Problem Solving Self-Efficacy (PSI-PSSE). Each item is responded from 1 (strongly disagree) to 6 (strongly agree), with higher scores meaning higher problem-solving self-efficacy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['problem-solving', 'youth', 'brief intervention', 'online intervention', 'young people', 'aggressive behaviour'], 'conditions': ['Aggression']}, 'descriptionModule': {'briefSummary': 'Aggressive behaviour among adolescents is a social problem that can be reduced by social problem-solving interventions. However, these interventions usually include more than one technique, and the specific techniques that are effective in reducing and preventing aggression remain to be identified. Therefore, the main aim of this study is to test whether the instruction and practice of problem-solving on their own are effective in changing aggressive behaviour among adolescents.\n\nAs the intervention in this trial is aimed at the general population, it will be delivered online. The rapid growth in the use of the Internet among young people provides an opportunity to deliver interventions universally in a cheap and efficient way.\n\nProblem-solving skills are fundamental to effective behaviour change. Therefore, problem-solving skills will be measured to assess whether they mediate the effect of the intervention on aggressive behaviour.\n\nFinally, young people with callous-unemotional traits are less likely to change their problematic behaviour such as aggression after an intervention. Therefore, Callous-Unemotional traits will be measured to assess if they act as a moderator of effectiveness.\n\nIt is expected that participants randomised to the intervention improve their problem-solving skills and consequentially, reduce their aggressive behaviours. In addition, participants with lower callous-unemotional traits are expected to have a greater change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '21 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living in the UK\n* Fluent in English'}, 'identificationModule': {'nctId': 'NCT04130360', 'briefTitle': 'A Trial of an Online Problem-solving Intervention for Aggression', 'organization': {'class': 'OTHER', 'fullName': 'University of Sheffield'}, 'officialTitle': 'A Randomized Controlled Trial of an Online Problem-solving Intervention to Reduce Aggression Among Youth', 'orgStudyIdInfo': {'id': '030755'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Problem-solving', 'interventionNames': ['Behavioral: Problem-solving']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Problem-solving', 'type': 'BEHAVIORAL', 'otherNames': ['social problem-solving'], 'description': 'The steps of problem-solving are explained to the participants. Then, they are presented two conflictive situations and they are asked to apply the problem-solving steps to find a solution. Once they finish, they are asked to apply the steps in a conflictive situation they have experience in the last month. In the end, they are reminded of the steps and encouraged to practice them in their daily conflicts.', 'armGroupLabels': ['Problem-solving']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S1 2LT', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'University of Sheffield', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Laura Castillo-Eito', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sheffield'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymised data will be shared, but there is not a concrete plan at the moment.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sheffield', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}