Stress Management Intervention in Inner City Adolescents With Asthma

Asthma Clinical Trial

— SIPIICAA  

Official title:

Pilot Study: Stress Management Intervention as a Tool for Managing Persistent Asthma in Inner City Adolescent Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01445015
• Other study ID #: 5T32HS000066
• Status: Recruiting
• Phase: Phase 2
• First received: September 29, 2011
• Last updated: September 30, 2011
• Start date: July 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2011
• Source: Weill Medical College of Cornell University
• Contact: Lisa Moreno, MD
• Phone: 718-350-6680
• Email: lim2022[@]med.cornell.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Psychosocial Stress

Intervention

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

Locations

Country	Name	City	State
United States	Cornell Weill Pulmonary/Allergy pediatric clinics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale		5 weeks	No
Secondary	Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope		5 weeks	No
Secondary	Secondary outcomes within scope of change from enrollment to completion of study in anxiety as measured by State Trait Inventory		5 weeks	No
Secondary	Secondary outcomes within scope of change from enrollment to completion of study in quality of life as assessed by PAQLQ		5 weeks	No