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

Primary Purpose

Asthma, Psychosocial Stress

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stress management program
Peer viewed movies
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring adolescents

Eligibility Criteria

8 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cornell Weill Pulmonary/Allergy pediatric clinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stress management program

peer viewed movies

Arm Description

Outcomes

Primary Outcome Measures

Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale

Secondary Outcome Measures

Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope
Secondary outcomes within scope of change from enrollment to completion of study in anxiety as measured by State Trait Inventory
Secondary outcomes within scope of change from enrollment to completion of study in quality of life as assessed by PAQLQ

Full Information

First Posted
September 29, 2011
Last Updated
September 30, 2011
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01445015
Brief Title
Stress Management Intervention in Inner City Adolescents With Asthma
Acronym
SIPIICAA
Official Title
Pilot Study: Stress Management Intervention as a Tool for Managing Persistent Asthma in Inner City Adolescent Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Psychosocial Stress
Keywords
adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stress management program
Arm Type
Experimental
Arm Title
peer viewed movies
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Stress management program
Intervention Description
10 session intervention utilizing a cognitive behavorial program with a goal of stress reduction
Intervention Type
Other
Intervention Name(s)
Peer viewed movies
Intervention Description
PG rated movies to be viewed over 10 sessions in peer setting
Primary Outcome Measure Information:
Title
Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope
Time Frame
5 weeks
Title
Secondary outcomes within scope of change from enrollment to completion of study in anxiety as measured by State Trait Inventory
Time Frame
5 weeks
Title
Secondary outcomes within scope of change from enrollment to completion of study in quality of life as assessed by PAQLQ
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Moreno, MD
Phone
718-350-6680
Email
lim2022@med.cornell.edu
Facility Information:
Facility Name
Cornell Weill Pulmonary/Allergy pediatric clinics
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Moreno, MD
Phone
718-350-6680
Email
lim2022@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Lisa Moreno, MD

12. IPD Sharing Statement

Learn more about this trial

Stress Management Intervention in Inner City Adolescents With Asthma

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