Stress Management Intervention in Inner City Adolescents With Asthma (SIPIICAA)
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ClinicalTrials.gov Identifier: NCT01445015 |
Recruitment Status
: Unknown
Verified September 2011 by Lisa Moreno, Weill Medical College of Cornell University.
Recruitment status was: Recruiting
First Posted
: October 3, 2011
Last Update Posted
: October 3, 2011
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Sponsor:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Lisa Moreno, Weill Medical College of Cornell University
Tracking Information | |||
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First Submitted Date ICMJE | September 29, 2011 | ||
First Posted Date ICMJE | October 3, 2011 | ||
Last Update Posted Date | October 3, 2011 | ||
Study Start Date ICMJE | July 2011 | ||
Estimated Primary Completion Date | February 2012 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale [ Time Frame: 5 weeks ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Stress Management Intervention in Inner City Adolescents With Asthma | ||
Official Title ICMJE | Pilot Study: Stress Management Intervention as a Tool for Managing Persistent Asthma in Inner City Adolescent Patients. | ||
Brief Summary | The study will utilize a stress management program delivered over 10 sessions that is hypothesized to result in decreased stress levels and improved coping strategies in an inner city adolescent asthma population. Participants will include adolescents ages 10-15 years with physician diagnosed asthma. The outcome measures will be obtained via psychosocial questionnaires and spirometry. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Estimated Enrollment ICMJE |
50 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date | June 2012 | ||
Estimated Primary Completion Date | February 2012 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 8 Years to 15 Years (Child) | ||
Accepts Healthy Volunteers | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01445015 | ||
Other Study ID Numbers ICMJE | 5T32HS000066( U.S. AHRQ Grant/Contract ) | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Lisa Moreno, Weill Medical College of Cornell University | ||
Study Sponsor ICMJE | Weill Medical College of Cornell University | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Weill Medical College of Cornell University | ||
Verification Date | September 2011 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |