Adolescent - Emotional ProblemNCT00592696
TRIAD Project: Qualitative Study of Adolescent Depression and Smoking
An observational study of Adolescent - Emotional Problem and Smoking, run by Drexel University College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent - Emotional Problem, Smoking
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Feb 2010
- Phase
- Observational
- 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 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents ages 12-19 who live with their parental guardian who meet criteria for major depression and who smoke cigarettes.
Who may be able to join
- 12-19 years old
- Major depression
- Smoke cigarettes
- Lives with parents
- No confidentiality issues related to smoking
Who cannot join
- Non English speaking
- Suicidal ideation
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
About this study
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.
- Conditions
- Adolescent - Emotional Problem, Smoking
- Keywords
- Adolescent depression, Adolescent smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine relationships that exist between smoking and depression in adolescents
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startDec 2006
- Primary completionMay 2008
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent - Emotional ProblemStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Suzanne Levy, Drexel University
- Investigators
- Don Schwarz, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592696
- Sponsor's protocol ID
- 16039
- Status last verified
- Mar 2014
- First submitted
- 2 Jan 2008
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20053789
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIAD Project: Qualitative Study of Adolescent Depression and Smoking
- ClinicalTrials.gov ID
- NCT00592696
- Acronym / sponsor ID
- 16039
- Conditions
- Adolescent - Emotional Problem, Smoking
- Keywords
- Adolescent depression, Adolescent smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Drexel University College of MedicineUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- Dec 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 14 Jan 2008 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | – |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents ages 12-19 who live with their parental guardian who meet criteria for major depression and who smoke cigarettes.
Key inclusion criteria (5 listed)
- 12-19 years old
- Major depression
- Smoke cigarettes
- Lives with parents
- No confidentiality issues related to smoking
Key exclusion criteria (3 listed)
- Non English speaking
- Suicidal ideation
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine relationships that exist between smoking and depression in adolescents
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
- Results publication: PubMed 20053789Levy 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.
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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.
Don Schwarz, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent - Emotional Problem and Smoking, run by Drexel University College of Medicine 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 5 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: finished, as of the sponsor's last update on 31 Mar 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine relationships that exist between smoking and depression in adolescents (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00592696, which also lists 1 linked publication.
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 31 Mar 2014.