Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-25 @ 12:01 PM
Study NCT ID:
NCT01726361
Status:
WITHDRAWN
Last Update Posted:
2013-11-07
First Post:
2012-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multidimensional Treatment Foster Care for Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019955', 'term': 'Conduct Disorder'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'We were not able to recruit families', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-06', 'studyFirstSubmitDate': '2012-11-09', 'studyFirstSubmitQcDate': '2012-11-09', 'lastUpdatePostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Other outcomes', 'timeFrame': '12 months post baseline', 'description': 'crime (register and self-report) school truancy (register and self-report) general health including substance abuse (self-report)'}], 'primaryOutcomes': [{'measure': 'Strengths and difficulties questionnaire, Child Behavior Checklist', 'timeFrame': '12 months post baseline', 'description': 'Measuring child/youth behaviour'}], 'secondaryOutcomes': [{'measure': 'Parental Stress Scale', 'timeFrame': '12 months post baseline', 'description': 'Measuring parental stress'}, {'measure': 'Sense of Cohesion 13', 'timeFrame': '12 months post baseline', 'description': 'Measuring stress in human functioning'}, {'measure': 'Ladder of life', 'timeFrame': '12 months post baseline', 'description': 'Measuring overall quality of life'}, {'measure': 'Major Depression Index 10', 'timeFrame': '12 months post baseline', 'description': "Measuring parent's depression symptoms"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multidimension Treatment Foster Care', 'Adolescents', 'Disadvantaged families', 'Out-of-home placement', 'Conduct Disorder', 'Family program', 'Denmark', 'Youth'], 'conditions': ['Adolescent Behaviour', 'Family Functioning']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the effects of Multidimensional Treatment Foster Care compared to treatment as usual (TAU) for adolescents in Denmark in need of out-of-home placement.', 'detailedDescription': 'It is difficult to treat adolescents with serious behaviour problems. Although the number of adolescents displaying serious behaviour problems is limited, they are a serious concern to the society e.g. because of their frequent violent behaviour, criminal activities and lack of school adherence.\n\nMultidimensional Treatment Foster Care (MTFC)is a community-based treatment program developed in USA. The goal of the MTFC program is to decrease problem behaviour and to increase developmentally appropriate normative and prosocial behavior in adolescents who are in need of out-of-home placement.\n\nThis study will evaluate the effect of MTFC on adolescents in out-of-home placement.\n\nParticipants will be recruited by caseworkers in the municipalities and randomly assigned to either MTFC or TAU. TAU will consist of other kinds of out-of-home placements. Outcomes will be assessed for all participants at baseline, post-treatment (12 months), and 12 months post-treatment. Parents and youth will be asked to fill out questionnaires on e.g. behaviour, parental stress, sense of cohesion, general health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12-17 years old\n* In need of out of home placement\n* serious behaviour problems\n\nExclusion Criteria:\n\n* severe psychiatric illness in youth or parent\n* risk of suicide in youth\n* acute psychosis in youth\n* sexual offence by youth\n* severe substance abuse in youth or parent'}, 'identificationModule': {'nctId': 'NCT01726361', 'briefTitle': 'Multidimensional Treatment Foster Care for Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'VIVE - The Danish Center for Social Science Research'}, 'officialTitle': 'Multidimensional Treatment Foster Care for Adolescents', 'orgStudyIdInfo': {'id': 'SFI 2506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MTFC', 'description': 'Out of home placement in MTFC family program', 'interventionNames': ['Behavioral: Multidimensional Treatment Foster Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAU', 'description': 'Other kind of out of home placement', 'interventionNames': ['Behavioral: Treatment as usual']}], 'interventions': [{'name': 'Multidimensional Treatment Foster Care', 'type': 'BEHAVIORAL', 'description': 'Out of home placement in MTFC family for 10-12 months', 'armGroupLabels': ['MTFC']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'otherNames': ['TAU'], 'description': 'Other kinds of out of home placement', 'armGroupLabels': ['TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1052', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'SFI the Danish National Centre for Social Research', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Mette Deding', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SFI the Danish National Centre for Social Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIVE - The Danish Center for Social Science Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Board of Social Services, Denmark', 'class': 'UNKNOWN'}, {'name': 'Ministry of Social Affairs, Denmark', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}