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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2011 by Lisa Moreno, Weill Medical College of Cornell University.
Recruitment status was: Recruiting

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

Tracking Information

First Received Date ^ICMJE

September 29, 2011

Last Updated Date

September 30, 2011

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

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 Blind (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

Estimated 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

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

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