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

Official Title: “Early Interventions for Anxious Children”

This study will evaluate the effectiveness of school-based cognitive behavioral therapy with or without parental involvement in treating children with anxiety disorders.

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 so far 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 children with anxiety disorders, including 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 forms about their own symptoms. The participants receiving CBT will then attend 9 weekly sessions held in the school buildings after school. In the parental involvement group, parents will attend 9 weekly group training sessions held at the same time as the child'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, possibly at Month 12, and at Years 1, 2, 3, and 4 post-treatment. The assessments will include repeat interviews and forms. 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 treatment.

Intervention(s) in this Clinical Trial

• Behavioral: Group CBT for children
  • CBT for children consists of 9 weekly group CBT sessions. All sessions occur in the school building during after-school hours.
• Behavioral: Group CBT for children plus parent training
  • CBT involving children and parents consists of 9 weekly group CBT sessions for the children and 9 weekly concurrent group parent training sessions.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • CBT for children only
• Experimental: 2
  • CBT for children with parental involvement
• No Intervention: 3
  • No intervention control group: families free to seek treatment on their own

Primary Measures

• Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV criteria for primary anxiety diagnosis
  • Time Frame: Measured at Months 3 and 6 and Years 1, 2, 3, and 4 post-treatment
    Safety Issue?: No

Secondary Measures

• Multidimensional Anxiety Scale for Children, Scale for Child Anxiety Related Emotional Disorders, Clinical Global Impressions, Family Adaptability and Cohesion Evaluation Scale II, and Behavior Assessment System for Children
  • Time Frame: Measured at Months 3 and 6 and Years 1, 2, 3, and 4 post-treatment
    Safety Issue?: No

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 necessarily 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 (OCD), post-traumatic stress disorder (PTSD), conduct disorder, schizophrenia, pervasive developmental disorder (PDD), major depression, bipolar disorder, or substance abuse
• Current suicidal or homicidal ideation
• Diagnosis of mental retardation (IQ less than 71) on the Kaufman Brief Intelligence
• Test (KBIT)
• Currently receiving psychotropic medication

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 7 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Institute of Mental Health (NIMH) NIH

Overall Clinical Trial Officials and Contacts

Gail A. Bernstein, MD Principal Investigator Division of Child and Adolescent Psychiatry, University of Minnesota Medical School  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00557648

Study ID Number: R21 MH065369

ClinicalTrials.gov Identifier: NCT00557648

Health Authority: United States: Federal Government