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

Tracking Information

First Received Date ^ICMJE

December 2, 2003

Last Updated Date

November 20, 2008

Start Date ^ICMJE

July 2002

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00073645 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Therapy Specificity and Mediation in Family and Group CBT

Brief Summary

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

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Anxiety Disorders

Intervention ^ICMJE

Behavioral: Peer/Group CBT
Behavioral: Family/Parents CBT

Study Arms / Comparison Groups

Experimental: Family/Parents CBT (FCBT) for 14 to 16 weekly sessions
Active Comparator: Peer/Group CBT (GCBT) for 14 to 16 weekly sessions

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

250

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00073645

Responsible Party

Wendy Silverman, PhD, Florida International University

Study ID Numbers ^ICMJE

R01 MH63997, DSIR 84-CTS

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Wendy K. Silverman, PhD

Florida International University

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP