Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-25 @ 4:46 PM
Study NCT ID:
NCT00164203
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-04', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Depression Inventory, Multi Anxiety Scale for children, Harter Inventory and Social Skills Rating Scale", 'timeFrame': 'pre/post intervention; 1-year follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': "Anxiety and mood disorders are among the most prevalent mental health problems in childhood. They have severe long-term morbidity, and associated academic and social impairment.\n\nBuilding on the investigators' experience with outcome evaluation in clinically anxious or depressed children, they propose to evaluate within the school system a cognitive behavioral therapy (CBT) intervention for children in grades 3 to 6 with elevated symptoms of anxiety or depression on standardized questionnaires.\n\nThe participant's outcomes will be compared with those of similar children randomly assigned to an activity control group.\n\nHypothesis 1a): Children in the intervention condition will show greater symptom reduction relative to children in the control condition (primary outcome: anxiety symptoms).\n\nHypothesis 1b): Children in the intervention condition will show fewer symptoms during follow-up relative to children in the control condition.\n\nHypothesis 2: Children with anxious or depressive symptoms treated in the school setting using CBT have a lower risk of developing internalizing disorders within 1 year of treatment than children in a control condition.\n\nHypothesis 3: Self-esteem, anxiety and depression-related impairment, and academic functioning will improve more in intervention participants than in controls.\n\nHypothesis 4: School characteristics, child age, and attitudes of participating personnel are predictive of treatment response."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children with t-score elevations \\> 60 on either the total score or at least 4 subscales of either instrument will be considered eligible for the study.\n\nExclusion Criteria:\n\n* Children will be excluded if they already meet criteria for disorders on the Anxiety Disorders Interview Schedule (ADIS), are unable to complete the inventories due to intellectual impairment or weak English skills (limiting the benefits of cognitive behavioral therapy), or if they are already engaged in ongoing psychiatric or psychological treatment that could confound study intervention effects.\n* Children with elevated 'externalizing' scores on the Child Behavior Checklist (CBCL) (t-score \\> 60) will also be excluded, as they are often difficult to manage in CBT groups, and may obtain more benefit from other interventions."}, 'identificationModule': {'nctId': 'NCT00164203', 'briefTitle': 'The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders', 'orgStudyIdInfo': {'id': 'CBT_FC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy', 'description': 'School-based, 12-session protocol, weekly', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy', 'Behavioral: School-based CBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'activity control condition', 'description': 'Structured games and activities, weekly for 12 weeks', 'interventionNames': ['Behavioral: activity control condition']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': '12-session, weekly, school-based protocol based on cognitive restructuring, tailored to children Grades 3 to 6; comparison with activity control condition of equal duration.', 'armGroupLabels': ['Cognitive Behavioral Therapy']}, {'name': 'School-based CBT', 'type': 'BEHAVIORAL', 'description': '12 sessions, weekly', 'armGroupLabels': ['Cognitive Behavioral Therapy']}, {'name': 'activity control condition', 'type': 'BEHAVIORAL', 'description': 'weekly games \\& activities x 12 weeks', 'armGroupLabels': ['activity control condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 1R8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Katharina Manassis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr.Katarina Manassis', 'oldOrganization': 'CAMH'}}}}