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

September 30, 2011 updated by: Lisa Moreno, Weill Medical College of Cornell University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Cornell Weill Pulmonary/Allergy pediatric clinics
        • Contact:
        • Principal Investigator:
          • Lisa Moreno, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope
Time Frame: 5 weeks
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
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
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (Estimate)

October 3, 2011

Study Record Updates

Last Update Posted (Estimate)

October 3, 2011

Last Update Submitted That Met QC Criteria

September 30, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5T32HS000066 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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