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| Sponsor: | 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 |
| 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 |
| 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.
|
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 |
Inclusion criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Florida International University | |
| Miami, Florida, United States, 33174 | |
| 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 |
| Study First Received: | December 2, 2003 |
| Last Updated: | November 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00073645 History of Changes |
| Health Authority: | United States: Federal Government |
|
Pathologic Processes Disease Anxiety Disorders Mental Disorders |