AsthmaPhase 2SIPIICAANCT01445015
Stress Management Intervention in Inner City Adolescents With Asthma
A Phase 2 study testing Stress management program and Peer viewed movies in people with Asthma and Psychosocial Stress, run by Weill Medical College of Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Psychosocial Stress
- What is being tested?
- Stress management program and Peer viewed movies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 8-15 years of age
- Physician diagnosed asthma based on NHBLI guidelines
- English speaking
- Child assent/parental consent
Who cannot join
- Refusal of child assent/parental consent
- Non-English speaking
- History of psychiatric illness, autoimmune disease, HIV/AIDs, smoking history.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cornell Weill Pulmonary/Allergy pediatric clinics
New York, New York, 10021
Lisa Moreno, MD, 718-350-6680, lim2022@med.cornell.edu
Lisa Moreno, MD
About this study
Official title: 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.
- Conditions
- Asthma, Psychosocial Stress
- Being tested
- Stress management program, Peer viewed movies
- Keywords
- adolescents
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress management programBehavioural
10 session intervention utilizing a cognitive behavorial program with a goal of stress reduction
Peer viewed moviesOther
PG rated movies to be viewed over 10 sessions in peer setting
| Study group | Role | What they receive |
|---|---|---|
| Stress management program | Experimental | Not described Receives: Behavioral: Stress management program |
| peer viewed movies | Active comparator | Not described Receives: Other: Peer viewed movies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale
Measured: 5 weeks
Secondary outcomes (3)
Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope
Measured: 5 weeks
Secondary outcomes within scope of change from enrollment to completion of study in anxiety as measured by State Trait Inventory
Measured: 5 weeks
Secondary outcomes within scope of change from enrollment to completion of study in quality of life as assessed by PAQLQ
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Moreno, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445015
- Sponsor's protocol ID
- 5T32HS000066
- Acronym
- SIPIICAA
- Status last verified
- Sep 2011
- First submitted
- 29 Sep 2011
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Stress Management Intervention as a Tool for Managing Persistent Asthma in Inner City Adolescent Patients.
- ClinicalTrials.gov ID
- NCT01445015
- Acronym / sponsor ID
- SIPIICAA / 5T32HS000066
- Conditions
- Asthma, Psychosocial Stress
- Keywords
- adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress management program | Experimental | Behavioral: Stress management program |
| peer viewed movies | Active comparator | Other: Peer viewed movies |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 8-15 years of age
- Physician diagnosed asthma based on NHBLI guidelines
- English speaking
- Child assent/parental consent
Key exclusion criteria (3 listed)
- Refusal of child assent/parental consent
- Non-English speaking
- History of psychiatric illness, autoimmune disease, HIV/AIDs, smoking history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress management program10 session intervention utilizing a cognitive behavorial program with a goal of stress reduction | Behavioural | Stress management program |
| Peer viewed moviesPG rated movies to be viewed over 10 sessions in peer setting | Other | peer viewed movies |
Primary outcome
Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale
Time frame: 5 weeks
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stress management program and Peer viewed movies in people with Asthma and Psychosocial Stress, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Moreno, MD (718-350-6680, lim2022@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2011.