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Completed

NCT Number: NCT00164203

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

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.

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Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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.

School-based CBT

Behavioral

12 sessions, weekly

activity control condition

Behavioral

weekly games & activities x 12 weeks

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2011
First posted
Sep 14, 2005
Registry last updated
Aug 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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