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

This study has been completed.
Sponsor:
Information provided by:
Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00164203
First received: September 9, 2005
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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 Intervention
Anxiety
Depression
Behavioral: Cognitive Behavioral Therapy
Behavioral: School-based CBT
Behavioral: activity control condition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: April 2005
Study Completion Date: August 2011
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164203

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Katharina Manassis, MD Centre for Addiction and Mental Health
  More Information

No publications provided

Responsible Party: Dr.Katarina Manassis, CAMH
ClinicalTrials.gov Identifier: NCT00164203     History of Changes
Other Study ID Numbers: CBT_FC
Study First Received: September 9, 2005
Last Updated: August 4, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014