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Family and Peer Involvement in the Treatment of Anxiety Disorders in Children

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), March 2007

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00073645
  Purpose

This study will compare the effectiveness of family- and peer-oriented therapy in treating children with anxiety disorders.


Condition Intervention Phase
Anxiety Disorders
Behavioral: Cognitive Behavior Therapy
Phase I

MedlinePlus related topics:   Anxiety   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Therapy Specificity and Mediation in Family and Group CBT

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:   250
Study Start Date:   July 2002
Estimated Study Completion Date:   June 2007

Detailed Description:

Data suggest that individual Cognitive Behavior Therapy (CBT) is effective in reducing anxiety disorders in children. The incorporation of family and peers in a CBT treatment program may be more effective in reducing anxiety symptoms than CBT alone because a child's environment affects the development, course, and outcome of childhood psychopathology and functional status. This study will evaluate the effectiveness of family and peer involvement in CBT treatment.

Children and their parents will be randomly assigned to one of two treatment conditions: Family/Parents CBT (FCBT) or Peer/Group CBT (GCBT) for 14 to 16 weekly sessions. Parent-child relationships are the focus of the FCBT. Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children. Children in the GCBT group will be trained to be more helpful and positive toward other children through role-playing activities. Interviews, questionnaires, and behavior observation tasks will be used to assess participants. All participants will be assessed at pretreatment, post-treatment, and at yearly follow-up visits for 5 years.

  Eligibility
Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion criteria:

  • DSM-IV criteria for Generalized Anxiety Disorder (GAD), Social Phobia (SP), or Separation Anxiety Disorder (SAD)
  • Mean score >= 4 on the Clinician's Rating Scale of Severity
  • Discontinuation of all other psychosocial treatment upon consultation with clinic staff and the service provider

Exclusion Criteria:

  • DSM-IV criteria for a disorder other than GAD, SP, and SAD
  • Diagnosis of any one of the following: pervasive developmental disorders, mental retardation, selective mutism, organic mental disorders, or schizophrenia and other psychotic disorders
  • At risk for harm to self or others
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073645

Locations
United States, Florida
Florida International University     Recruiting
      Miami, Florida, United States, 33174
      Contact: Patricia R. Alvarez     305-348-2494     Patricia.Alvarez@fiu.edu    
      Principal Investigator: Wendy K. Silverman, PhD            
      Sub-Investigator: William Kurtines, PhD            

Sponsors and Collaborators
  More Information

Study ID Numbers:   R01 MH63997, DSIR 84-CTS
First Received:   December 2, 2003
Last Updated:   March 13, 2007
ClinicalTrials.gov Identifier:   NCT00073645
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on July 18, 2008




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