Stress Management Intervention in Inner City Adolescents With Asthma
SIPIICAA
Pilot Study: Stress Management Intervention as a Tool for Managing Persistent Asthma in Inner City Adolescent Patients.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
October 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 3, 2011
September 1, 2011
7 months
September 29, 2011
September 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale
5 weeks
Secondary Outcomes (3)
Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope
5 weeks
Secondary outcomes within scope of change from enrollment to completion of study in anxiety as measured by State Trait Inventory
5 weeks
Secondary outcomes within scope of change from enrollment to completion of study in quality of life as assessed by PAQLQ
5 weeks
Study Arms (2)
Stress management program
EXPERIMENTALpeer viewed movies
ACTIVE COMPARATORInterventions
10 session intervention utilizing a cognitive behavorial program with a goal of stress reduction
PG rated movies to be viewed over 10 sessions in peer setting
Eligibility Criteria
You may qualify if:
- Ages 8-15 years of age
- Physician diagnosed asthma based on NHBLI guidelines
- English speaking
- Child assent/parental consent
You may not qualify if:
- Refusal of child assent/parental consent
- Non-English speaking
- History of psychiatric illness, autoimmune disease, HIV/AIDs, smoking history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cornell Weill Pulmonary/Allergy pediatric clinics
New York, New York, 10021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 29, 2011
First Posted
October 3, 2011
Study Start
July 1, 2011
Primary Completion
February 1, 2012
Study Completion
June 1, 2012
Last Updated
October 3, 2011
Record last verified: 2011-09