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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2011-08-31

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.

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Detailed Description

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Conditions

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Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Cognitive Behavioral Therapy

School-based, 12-session protocol, weekly

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type 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

Intervention Type BEHAVIORAL

12 sessions, weekly

activity control condition

Structured games and activities, weekly for 12 weeks

Group Type ACTIVE_COMPARATOR

activity control condition

Intervention Type BEHAVIORAL

weekly games \& activities x 12 weeks

Interventions

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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.

Intervention Type BEHAVIORAL

School-based CBT

12 sessions, weekly

Intervention Type BEHAVIORAL

activity control condition

weekly games \& activities x 12 weeks

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No