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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00620958 |
This study will compare the effectiveness of individual cognitive behavioral therapy with two distinct types of parent involvement versus individual cognitive behavioral therapy without parent involvement in treating children with anxiety disorders.
Condition | Intervention | Phase |
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Anxiety Disorders |
Behavioral: Individual cognitive behavioral therapy (ICBT) Behavioral: Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT) Behavioral: Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Parent Mediation of Child Anxiety CBT Outcome |
Estimated Enrollment: | 336 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive individual cognitive behavioral therapy with parent reinforcement training.
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Behavioral: Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)
Parent reinforcement training will teach the parent strategies for managing the child's behavior through the use of positive rewards and positive parental behaviors to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
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2: Experimental
Participants will receive individual cognitive behavioral therapy with parent relationship training.
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Behavioral: Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT)
Parent relationship training will teach the parent ways to communicate with the child and to solve problems to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
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3: Active Comparator
Participants will receive individual cognitive behavioral therapy alone.
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Behavioral: Individual cognitive behavioral therapy (ICBT)
ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
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Anxiety disorders are among the most common emotional, behavioral, and mental disorders in children, affecting an estimated 1 out of every 10 children and adolescents. Symptoms of anxiety disorders include an excessive sense of worry, stress, and fear; headache; nausea; and impaired learning and concentration. If left untreated, anxiety disorders can lead to difficulties with school and relationships, substance abuse, and the persistence of anxiety problems into adulthood. Individual cognitive behavioral therapy (ICBT), in which children learn to cope with fears through behavior and thought modification, has been an effective form of treatment for children with anxiety disorders. Studies have indicated that ICBT involving children and parents may be more effective than ICBT involving only children for improving anxiety levels and long-term recovery rates. This study will compare the effectiveness of ICBT with either parent reinforcement training or parent relationship training versus ICBT without parent involvement in treating children with anxiety disorders.
Participation in this study will last 15 months, with 3 months of treatment and 12 months of follow-up. Both parent and child participants will first undergo initial assessments that will include psychological questionnaires; a video-taped child-parent interaction session; and interviews about behaviors, psychological functioning, and problem situations. Participants will then be assigned randomly to one of three treatment groups: ICBT, ICBT with parent reinforcement training (PRT1), or ICBT with parent relationship training (PRT2). All participants will attend between 12 and 14 weekly treatment sessions, lasting 60 minutes each. During all sessions, child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events. ICBT PRT1 and ICBT PRT2 sessions will also involve the parent and child working together. ICBT PRT1 will specifically teach the parent strategies for managing the child's behavior through the use of positive rewards and positive parental behaviors to help discourage child avoidant behaviors. ICBT PRT2 will specifically teach the parent ways to communicate with the child and to solve problems to help discourage child avoidant behaviors.
All participants will be asked to complete questionnaires throughout treatment, upon completion of treatment, and 6 months after the end of treatment. Three and 9 months after the end of treatment, participants will undergo a 15-minute telephone assessment to evaluate how the child participant has been doing. The final assessment will occur 12 months after the end of treatment and will include repeat interviews and questionnaires.
Ages Eligible for Study: | 8 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wendy K. Silverman, PhD | 305-348-2064 | Wendy.Silverman@fiu.edu |
United States, Florida | |
Florida International University | Recruiting |
Miami, Florida, United States, 33139 | |
Contact: Wendy K. Silverman, PhD 305-348-2064 Wendy.Silverman@fiu.edu | |
Contact: William M. Kurtines, PhD 305-348-2880 William.Kurtines@fiu.edu | |
Principal Investigator: Wendy K. Silverman, PhD |
Principal Investigator: | Wendy K. Silverman, PhD | Florida International University |
Responsible Party: | Office of Sponsored Research Division: Division of Research ( Roberto M. Gutierrez ) |
Study ID Numbers: | R01 MH079943, DSIR 84-CTS, 1 R01 MH079943-01A1 |
Study First Received: | February 20, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00620958 |
Health Authority: | United States: Federal Government |
Mediation Outcome CBT Child Anxiety Intervention |
Anxiety Disorders Mental Disorders |
Pathologic Processes Disease |