The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders
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.
Building 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.
The participant's outcomes will be compared with those of similar children randomly assigned to an activity control group.
Hypothesis 1a): Children in the intervention condition will show greater symptom reduction relative to children in the control condition (primary outcome: anxiety symptoms).
Hypothesis 1b): Children in the intervention condition will show fewer symptoms during follow-up relative to children in the control condition.
Hypothesis 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.
Hypothesis 3: Self-esteem, anxiety and depression-related impairment, and academic functioning will improve more in intervention participants than in controls.
Hypothesis 4: School characteristics, child age, and attitudes of participating personnel are predictive of treatment response.
|Anxiety Depression||Behavioral: Cognitive Behavioral Therapy Behavioral: School-based CBT Behavioral: activity control condition|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders|
- 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 ]
|Study Start Date:||April 2005|
|Study Completion Date:||August 2011|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Experimental: Cognitive Behavioral Therapy
School-based, 12-session protocol, weekly
Behavioral: Cognitive Behavioral Therapy
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.Behavioral: School-based CBT
12 sessions, weekly
Active Comparator: activity control condition
Structured games and activities, weekly for 12 weeks
Behavioral: activity control condition
weekly games & activities x 12 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT00164203
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Principal Investigator:||Katharina Manassis, MD||Centre for Addiction and Mental Health|