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

NCT00164203 | Completed

• 1 other identifier: CBT_FC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Children's Depression Inventory, Multi Anxiety Scale for children, Harter Inventory and Social Skills Rating Scale

  pre/post intervention; 1-year follow-up

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

School-based, 12-session protocol, weekly

Behavioral: Cognitive Behavioral Therapy; Behavioral: School-based CBT

activity control condition

ACTIVE COMPARATOR

Structured games and activities, weekly for 12 weeks

Behavioral: activity control condition

Interventions

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.

Cognitive Behavioral Therapy

School-based CBT BEHAVIORAL

12 sessions, weekly

Cognitive Behavioral Therapy

activity control condition BEHAVIORAL

weekly games \& activities x 12 weeks

activity control condition

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Katharina Manassis, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: August 1, 2011
• Last Updated: August 5, 2011

Record last verified: 2011-08

Locations

CA (1)