TRIAD Project: Qualitative Study of Adolescent Depression... | NCT00592696

Studies
TRIAD Project: Qualitative Study of Adolescent Depression and Smoking

NCT00592696

Sponsor

Drexel University College of Medicine

Status

Completed

Last Update Posted

Mar 31, 2014Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Adolescent - Emotional Problem
Smoking

Interventions

Not provided

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

May 2008Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jan 2, 2008

First Submission Date that Met QC Criteria

Jan 11, 2008

First Posted Date

Jan 14, 2008Estimated

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

Mar 27, 2014

Last Update Posted Date

Mar 31, 2014Estimated

Name	Class
Children's Hospital of Philadelphia	OTHER

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

It has been shown in the adult literature that smoking is related to depression and visa versa. Not much is known about how this relationship is started or if one perhaps leads to the other. We are performing 1 hour long interviews with adolescents ages 12-19 who meet criteria for major depression and who smoke. They are interviewed along with their parent. Questions center around their view of depression and their history of depression as well as questions around their smoking as well as the interrelationships between the two. Transcripts are made of the interview and are being analyzed for themes.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
Observation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine relationships that exist between smoking and depression in adolescents		1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

12-19 years old
Major depression
Smoke cigarettes
Lives with parents
No confidentiality issues related to smoking

Exclusion Criteria:

Non English speaking
Suicidal ideation
Pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Adolescents ages 12-19 who live with their parental guardian who meet criteria for major depression and who smoke cigarettes.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Don Schwarz, MD	Children's Hospital of Philadelphia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Christopher's Hospital for Children		Philadelphia	Pennsylvania	19134	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20053789	Result	Levy SA, Westin AM, Reamy AM, Reyner JC, Syed T, Diamond GS. Communication about smoking between depressed adolescents and their parents. Nicotine Tob Res. 2010 Mar;12(3):191-7. doi: 10.1093/ntr/ntp192. Epub 2010 Jan 6.