The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00164203|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : August 5, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Depression||Behavioral: Cognitive Behavioral Therapy Behavioral: School-based CBT Behavioral: activity control condition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||August 2011|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164203
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Principal Investigator:||Katharina Manassis, MD||Centre for Addiction and Mental Health|