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Completed

NCT Number: NCT00557648

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

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

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Divisions of Child and Adolescent Psychiatry, University of Minnesota Medical School

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group CBT for children

Behavioral

CBT for children consists of 9 weekly group CBT sessions. All sessions occur in the school building during after-school hours.

Group CBT for children plus parent training

Behavioral

CBT involving children and parents consists of 9 weekly group CBT sessions for the children and 9 weekly concurrent group parent training sessions.

Primary outcomes

  1. Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV for primary anxiety diagnosis

    Time frame: Measured at Month 6 and Years 1, 2, 3, and 4 post-treatment

Secondary outcomes

  1. 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

    Time frame: Measured at Months 3 and 6 and Years 1, 2, 3, and 4 post-treatment

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Early Interventions for Anxious Children

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Nov 14, 2007
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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