Early Intervention for Children at Risk for Anxiety
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|ClinicalTrials.gov Identifier: NCT00865306|
Recruitment Status : Completed
First Posted : March 19, 2009
Results First Posted : October 13, 2010
Last Update Posted : October 13, 2010
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorder||Behavioral: "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Early Intervention for Children at Risk for Anxiety|
|Study Start Date :||March 1998|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
Experimental: Active CBT
Seven parent-only and 8-13 child-only sessions focusing on CBT for anxiety disorders using the "Being Brave" protocol.
Behavioral: "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."
This is a cognitive-behavioral intervention modeled loosely after Kendall's "Coping Cat," which includes 7 parent-only sessions and 8-13 child-only sessions. It focuses on helping parents learn strategies for coaching their child in coping with anxiety, and on teaching the child coping skills and carrying out exposure exercises in session and in parent-child homework assignments.
No Intervention: No intervention (wait-list controls)
Control children received no intervention.
- Number of Responders Based on Clinician Global Impression-Anxiety Improvement [ Time Frame: Post-Treatment (6-months from baseline) ]Clinicians blind to treatment assignment rated the child's global improvement on anxiety, using the Clinician Global Impression-Anxiety Improvement scale (CGI-Anxiety, best value 1, worst value 7). Responders were considered those with "very much" or "much" improvement (CGI-Anxiety scores of 1 or 2)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865306
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Dina Hirshfeld-Becker, PhD||Massachusetts General Hospital|