Family and Peer Involvement in the Treatment of Anxiety Disorders in Children - Full Text View

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

National Institute of Mental Health (NIMH)

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