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Family and Peer Involvement in the Treatment of Anxiety Disorders in Children
This study has been completed.
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: Peer/Group CBT
Behavioral: Family/Parents CBT
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
Study Completion Date:
November 2008
Primary Completion Date:
November 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Family/Parents CBT (FCBT) for 14 to 16 weekly sessions
Behavioral: Family/Parents CBT
Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children.
2: Active Comparator
Peer/Group CBT (GCBT) for 14 to 16 weekly sessions
Behavioral: Peer/Group CBT
Children will be trained to be more helpful and positive toward other children through role-playing activities.

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
Miami, Florida, United States, 33174
Sponsors and Collaborators
Investigators
Principal Investigator: Wendy K. Silverman, PhD Florida International University
  More Information

Responsible Party:
Florida International University ( Wendy Silverman, PhD )
Study ID Numbers:
R01 MH63997, DSIR 84-CTS
First Received:
December 2, 2003
Last Updated:
November 20, 2008
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 January 07, 2009