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

C

Center for Addiction and Mental Health (CAMH)

Status

Completed

Conditions

Depression
Anxiety

Treatments

Behavioral: activity control condition
Behavioral: School-based CBT
Behavioral: Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

7 to 13 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 2 patient groups

Cognitive Behavioral Therapy
Experimental group
Description:
School-based, 12-session protocol, weekly
Treatment:
Behavioral: School-based CBT
Behavioral: Cognitive Behavioral Therapy
activity control condition
Active Comparator group
Description:
Structured games and activities, weekly for 12 weeks
Treatment:
Behavioral: activity control condition

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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