Stress Management Intervention in Inner City Adolescents With Asthma (SIPIICAA)

Tracking Information
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; (submitted: September 30, 2011)	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; (submitted: September 30, 2011)	Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope [ Time Frame: 5 weeks ]; Secondary outcomes within scope of change from enrollment to completion of study in anxiety as measured by State Trait Inventory [ Time Frame: 5 weeks ]; Secondary outcomes within scope of change from enrollment to completion of study in quality of life as assessed by PAQLQ [ Time Frame: 5 weeks ]
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
Condition ICMJE	Asthma; Psychosocial Stress
Intervention ICMJE	Behavioral: Stress management program 10 session intervention utilizing a cognitive behavorial program with a goal of stress reduction; Other: Peer viewed movies PG rated movies to be viewed over 10 sessions in peer setting
Study Arms	Experimental: Stress management program Intervention: Behavioral: Stress management program; Active Comparator: peer viewed movies Intervention: Other: Peer viewed movies
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: September 30, 2011)	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: Ages 8-15 years of age; Physician diagnosed asthma based on NHBLI guidelines; English speaking; Child assent/parental consent Exclusion Criteria: Refusal of child assent/parental consent; Non-English speaking; History of psychiatric illness, autoimmune disease, HIV/AIDs, smoking history.
Sex/Gender	Sexes Eligible for Study: All
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