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

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
School-based CBT
activity control condition
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy

activity control condition

Arm Description

School-based, 12-session protocol, weekly

Structured games and activities, weekly for 12 weeks

Outcomes

Primary Outcome Measures

Children's Depression Inventory, Multi Anxiety Scale for children, Harter Inventory and Social Skills Rating Scale

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
August 4, 2011
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT00164203
Brief Title
The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders
Official Title
The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
School-based, 12-session protocol, weekly
Arm Title
activity control condition
Arm Type
Active Comparator
Arm Description
Structured games and activities, weekly for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
School-based CBT
Intervention Description
12 sessions, weekly
Intervention Type
Behavioral
Intervention Name(s)
activity control condition
Intervention Description
weekly games & activities x 12 weeks
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharina Manassis, MD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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