Stress Management Intervention in Inner City Adolescents... | NCT01445015

Studies
Stress Management Intervention in Inner City Adolescents With Asthma

NCT01445015

Sponsor

Weill Medical College of Cornell University

Status

Unknown status

Last Update Posted

Oct 3, 2011Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Asthma
Psychosocial Stress

Interventions

Stress management program
Peer viewed movies

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Feb 2012Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Sep 29, 2011

First Submission Date that Met QC Criteria

Sep 30, 2011

First Posted Date

Oct 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2011

Last Update Posted Date

Oct 3, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lisa Moreno, MD, Weill Medical College of Cornell UniversityPrincipal Investigator

Lead Sponsor

Weill Medical College of Cornell UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stress management program	Experimental		Behavioral: Stress management program
peer viewed movies	Active Comparator		Other: Peer viewed movies

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stress management program	Behavioral	10 session intervention utilizing a cognitive behavorial program with a goal of stress reduction	Stress management program

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lisa Moreno, MD	Contact	718-350-6680		lim2022@med.cornell.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cornell Weill Pulmonary/Allergy pediatric clinics	Recruiting	New York	New York	10021	United States

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided