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

This study is currently recruiting participants.
Verified September 2011 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Lisa Moreno, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01445015
First received: September 29, 2011
Last updated: September 30, 2011
Last verified: September 2011
History of Changes

September 29, 2011
September 30, 2011
July 2011
February 2012   (final data collection date for primary outcome measure)
Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01445015 on ClinicalTrials.gov Archive Site
  • Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Secondary outcomes within scope of change from enrollment to completion of study in anxiety as measured by State Trait Inventory [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Secondary outcomes within scope of change from enrollment to completion of study in quality of life as assessed by PAQLQ [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Stress Management Intervention in Inner City Adolescents With Asthma
Pilot Study: Stress Management Intervention as a Tool for Managing Persistent Asthma in Inner City Adolescent Patients.

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Asthma
  • Psychosocial Stress
  • 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
  • Experimental: Stress management program
    Intervention: Behavioral: Stress management program
  • Active Comparator: peer viewed movies
    Intervention: Other: Peer viewed movies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
8 Years to 15 Years
Yes
Contact: Lisa Moreno, MD 718-350-6680 lim2022@med.cornell.edu
United States
 
NCT01445015
5T32HS000066
No
Lisa Moreno, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Not Provided
Weill Medical College of Cornell University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP