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| Tracking Information | |||||
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| First Received Date ICMJE | March 5, 2004 | ||||
| Last Updated Date | December 11, 2008 | ||||
| Start Date ICMJE | September 2003 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task [ Time Frame: Measured pre- and post-treatment and at 6 and 12 month follow-up visits ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00078728 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Family-Based Prevention Program for Childhood Anxiety | ||||
| Official Title ICMJE | Family-Based Prevention for Childhood Anxiety | ||||
| Brief Summary | This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children. |
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| Detailed Description | Anxiety disorder is a serious condition that can negatively impact a person's overall functioning. This study will enroll mothers with anxiety disorders and their children to determine whether a brief family-based intervention will reduce childhood anxiety better than standard care. Participants will be randomly assigned to either the family-based prevention program or to evaluation only for 8 weeks. Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety. Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task will be used to assess participants. Assessments will be conducted at study start and one week after study completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after study completion. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Anxiety Disorders | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | July 2007 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00078728 | ||||
| Responsible Party | Golda S. Ginsburg, PhD, Johns Hopkins School of Medicine | ||||
| Study ID Numbers ICMJE | K23 MH63427, DDTR BK-TKPD | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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