Clinical Trials Directory

Trials / Completed

CompletedNCT00164203

The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
Centre for Addiction and Mental Health · Academic / Other
Sex
All
Age
7 Years – 13 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavioral Therapy12-session, weekly, school-based protocol based on cognitive restructuring, tailored to children Grades 3 to 6; comparison with activity control condition of equal duration.
BEHAVIORALSchool-based CBT12 sessions, weekly
BEHAVIORALactivity control conditionweekly games \& activities x 12 weeks

Timeline

Start date
2005-04-01
Primary completion
2007-12-01
Completion
2011-08-01
First posted
2005-09-14
Last updated
2011-08-05

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00164203. Inclusion in this directory is not an endorsement.