Evaluating the Effectiveness of Early Cognitive Behavioral Therapy With or Without Parental Involvement in Treating Anxious Children

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of school-based cognitive behavioral therapy with or without parental involvement in treating anxious children.

Detailed Description
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Anxiety disorders are among the most common disorders in children. Although anxiety is a normal part of growing up, the worrying experienced by children with anxiety disorders can persist to the point that day-to-day functioning becomes difficult. Physical symptoms of anxiety disorders include a constant sense of worry or stress, headache, nausea, sweating, shaking, and inability to concentrate. Early identification of anxiety disorders is important to prevent progression of the disorder into a chronic issue. Cognitive behavioral therapy (CBT), which focuses on behavioral and thinking modifications, has been shown to be the most effective treatment for anxiety disorders. This study will evaluate the effectiveness of school-based CBT with or without parental involvement in treating anxious children who meet DSM-IV criteria or have features of separation anxiety disorder, generalized anxiety disorder, and social phobia. Participants in this single blind study will be randomly assigned by school to one of three treatment groups: CBT for children only, CBT for children plus parent training, and no-treatment control. Each child and parent participant will first undergo an interview, lasting between 1 and 1.5 hours, about the child's symptoms. Additionally, parents will complete rating scales about their children's symptoms and their own symptoms. The participants receiving CBT will then attend 9 weekly group sessions held in the school buildings after school. In the parental involvement group, parents will attend 9 weekly group parent-training sessions held at the same time as the children's CBT group sessions. During the children's CBT sessions, participants will learn techniques to identify feelings of worry, relax, modify negative thoughts, break down difficult situations into smaller achievable steps, reward themselves for trying hard, and maintain treatment gains. For the parent training group, early sessions will focus on normalizing anxiety during childhood, learning about anxiety, and identifying when their children are feeling anxious. The middle sessions will teach parents the same anxiety management skills being taught to their children and ways to help their children to apply the steps at home. The latter sessions will instruct parents on ways to encourage their children's behaviors in anxiety-provoking situations. After completing the 9-week program, participants will attend 2 follow-up booster sessions at Months 1 and 3 post-treatment. Follow-up assessments will occur at Months 3 and 6 and at Years 1, 2, 3, and 4 post-treatment. The assessments will include repeat interviews and rating scales. At the end of the 6-month follow-up assessment, participants in the no-treatment control group will have the opportunity to participate in the CBT group treatments.

Official Title
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Early Interventions for Anxious Children

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Group CBT for children
* Behavioral: Group CBT for children plus parent training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total Anxiety T-score of greater than 57 on Multidimensional Anxiety Scale for Children and/or teacher nomination as one of the most anxious children in the classroom Meets DSM-IV criteria for separation anxiety disorder, generalized anxiety disorder, and/or social phobia, or features (one or more, but not all criteria) of one of these disorders with an associated composite CSR of 2 to 6 on ADIS Both parent and child speak English fluently Exclusion Criteria: Current diagnosis of the following on ADIS: obsessive-compulsive disorder, posttraumatic stress disorder, attention-deficit hyperactivity disorder, conduct disorder, schizophrenia, pervasive developmental disorder, major depression, or substance abuse Current suicidal or homicidal intent or plan Diagnosis of mental retardation (IQ less than 71) on the Kaufman Brief Intelligence Test (KBIT) Currently receiving psychotropic medication

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CBT for children only | Behavioral: Group CBT for children<br>* CBT for children consists of 9 weekly group CBT sessions. All sessions occur in the school building during after-school hours.<br>|
| Experimental: 2<br>CBT for children with parental involvement | Behavioral: Group CBT for children plus parent training<br>* CBT involving children and parents consists of 9 weekly group CBT sessions for the children and 9 weekly concurrent group parent training sessions.<br>|
| No Intervention: 3<br>No intervention control group: families free to seek treatment on their own | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV for primary anxiety diagnosis |  | Measured at Month 6 and Years 1, 2, 3, and 4 post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Anxiety Scale for Children, Scale for Child Anxiety Related Emotional Disorders, Clinical Global Impressions-Improvement Scale, Family Adaptability and Cohesion Evaluation Scale II, and Behavior Assessment System for Children |  | Measured at Months 3 and 6 and Years 1, 2, 3, and 4 post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Children, Cognitive-Behavioral Therapy, School-Based Interventions