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

Sponsor
Centre for Addiction and Mental Health (Other)
Overall Status
Completed
CT.gov ID
NCT00164203
Collaborator
(none)
150
1
2
76
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy
  • Behavioral: School-based CBT
  • Behavioral: activity control condition
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (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
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Children's Depression Inventory, Multi Anxiety Scale for children, Harter Inventory and Social Skills Rating Scale [pre/post intervention; 1-year follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00164203
Other Study ID Numbers:
  • CBT_FC
First Posted:
Sep 14, 2005
Last Update Posted:
Aug 5, 2011
Last Verified:
Aug 1, 2011
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2011