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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00164203 |
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Date of registration:
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09/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders
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Scientific title:
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The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00164203 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Katharina Manassis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre for Addiction and Mental Health |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Age minimum:
7 Years
Age maximum:
13 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anxiety
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Depression
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Intervention(s)
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Behavioral: School-based CBT
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Behavioral: Cognitive Behavioral Therapy
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Behavioral: activity control condition
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Primary Outcome(s)
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Children's Depression Inventory, Multi Anxiety Scale for children, Harter Inventory and Social Skills Rating Scale
[Time Frame: pre/post intervention; 1-year follow-up]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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