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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: School-based CBT
* Behavioral: activity control condition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br>School-based, 12-session protocol, weekly | Behavioral: Cognitive Behavioral Therapy<br>* 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.<br>Behavioral: School-based CBT<br>* 12 sessions, weekly<br>|
| Active Comparator: activity control condition<br>Structured games and activities, weekly for 12 weeks | Behavioral: activity control condition<br>* weekly games & activities x 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Depression Inventory, Multi Anxiety Scale for children, Harter Inventory and Social Skills Rating Scale |  | pre/post intervention; 1-year follow-up |