Text Size

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
  Purpose

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.


Condition Intervention Phase
Asthma
Psychosocial Stress
 Behavioral: Stress management program
Other: Peer viewed movies
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study: Stress Management Intervention as a Tool for Managing Persistent Asthma in Inner City Adolescent Patients.

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stress management program Behavioral: Stress management program
10 session intervention utilizing a cognitive behavorial program with a goal of stress reduction
Active Comparator: peer viewed movies Other: Peer viewed movies
PG rated movies to be viewed over 10 sessions in peer setting

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445015

Contacts
Contact: Lisa Moreno, MD 718-350-6680 lim2022@med.cornell.edu

Locations
United States, New York
Cornell Weill Pulmonary/Allergy pediatric clinics Recruiting
New York, New York, United States, 10021
Contact: Lisa Moreno, MD     718-350-6680     lim2022@med.cornell.edu    
Principal Investigator: Lisa Moreno, MD            
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Lisa Moreno, MD, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01445015     History of Changes
Other Study ID Numbers: 5T32HS000066
Study First Received: September 29, 2011
Last Updated: September 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
adolescents

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013