Title: Challenges in Adolescent Smoking Cessation Research
1Challenges in Adolescent Smoking Cessation
Research
- Deborah Moss MD MPH
- February 24 2009
2OBJECTIVES
- Overview of adolescent smoking
- Challenges of conducting adolescent cessation
research - Lessons from the field
- Implications
3Overview of teen smoking
- Why research on adolescent smoking is so critical
4- 90 of adult smokers started
smoking as teens
Reducing adolescent smoking is a public health
priority.
5Risks of Teen Smoking
- Health consequences
- Individual C-V disease asthma and other lung
disease malignancies fire injury meningitis - Community peer parent pregnant exposer
- Associated with other risk behaviors
- 3 x more likely to use alcohol
- 8 x more likely to smoke marijuana
- 22 x more likely to use cocaine
6Youth Risk Behavior Survey 2007 Results
before 13 based on a whole cigarette ever high
school use is one in last 30 days
The most important time for prevention is the
transition between middle school to high school
and first year of high school.
7Effective prevention strategies
- Parent disapproval
- Household rules (smoke-free home)
- Parental quitting
- Public health approaches
- Raise cigarette taxes
- Monitor cigarette sales to minors
- Reduce exposure to smoking behavior (regulate
smoking in movies advocate for smoke free public
places laws and policies)
8Viewing smoking related messages increases the
likelihood of smoking
- Movies (Dalton/Sargent 2000-2006)
- Advertising and promotions (Pierce 1996-1998)
9Tried Smoking (percent)
James Sargent (2005) www.smokefreemovies.ucsf.edu
10Teen cessation
11Do Teens Want to Quit
- Yes!
- 62 of high school students report a desire to
stop smoking (Marshall 2006)
12Do Teens Need Help to Quit
Yes!
- 53 of HS students reported at least one quit
attempt (Marshall 2006) - Yet 16 of teen smokers report quitting for 30
day period (Zhu 1999) - Teens underestimate addictive nature of nicotine
(TAPS)
www.helpteensquit.org
13Lack of effective treatment recommendations
- Insufficient evidence (Grimshaw 2006 Sussman
2006) - Research needs- Cochrane review
- Well-designed adequately powered RCTs for
adolescent smokers - Minimum follow-up of 6 months
- Rigorous definition of cessation (sustained
biochemical verification) - Recognize methodologic problems (recruitment
retention follow-up)
14Challenges in Youth Tobacco Use Research
15Challenges in youth tobacco control research
- 1. Human subject protection
- 2. Recruitment
- 3. Retention
- 4. Psychosocial complexities
161. Human subject protection
- Child as research subject
- Parental consent
- Confidentiality and mandatory reporting
- Vulnerable populations
- Variability of interpretation
Research implications subject recruitment
representativeness of sample adequacy of sample
size cost of study
172. Recruitment
- Accessing teens
- Lack of perceived benefit (personal or immediate)
- Perceived barriers loss of privacy time
commitment transportation - Appealing to adolescent interests
183. Retention
- Transience
- Maintaining contact
- Commitment
- Changing motivation
- Peer influence
194. Psychosocial complexity
- Psychiatric co-morbidity
- Low income populations
- Social determinants of risk behaviors
The scope of the these challenges in community
samples has not yet been described.
20Pennsylvania Adolescent Smoking Study (PASS)
PASS
21Primary Care Network for Adolescent Smoking
Cessation Research
- The Network consists of
- Childrens Hospital of Philadelphia
- Childrens Hospital of Pittsburgh
- Lehigh Valley Hospital
- St. Christophers Hospital for Children
- University of Pennsylvania
22PASS-overview
- Primary Aim
- Compare the efficacy of Motivational Interviewing
(MI) to Structured Brief Advice (SBA) on reducing
smoking in adolescents - Design
- Multicenter RCT study
- Methods
- Sample 330 teen smokers (14-18 years)
- Study groups 5 sessions of MI intervention or
SBA - Outcomes 8 12 24 week follow-up using self
report and time-line follow-back data Saliva
cotinine levels
23PASS Study Flow Chart
screened - 2759
enrolled 357 (13 of screened)
randomized to MI - 177
randomized to SBA - 178
8 weeks - 277
12 weeks - 272
24 weeks - 215
24PASS Recruitment site comparison
25PASS Recruitment strategies
- Community sites
- - Hill House
- - Hosanna House
- - Sarah Heinz House
- - Adagio Health
- - Tobacco Free Allegheny
- - Job Corps
- - Focus on Renewal
- - Planned Parenthood of Western PA
- -- Woman Infants and Children (WIC)
- - Saint Athanasius Church (West View)
- - Race for the Cure
- - American Cancer Society
- - American Lung Association
- - American Respiratory Alliance Heinz field
- - County pools
- - A Schools
- - Schools
- Clinical sites
- Adolescent Medicine at Childrens Hospital (CHP)
- Adolescent In-patient Unit at CHP
- Primary Care Center at CHP
- Family Medicine (Shadyside Matilda Theis)
- Childrens/UPMC at Turtle Creek
- Childrens Community Pediatrics (CCP)
- Pittsburgh Oakland Bloomfield offices
- Emergency Department at CHP
- Dental Department at CHP
- Pulmonary Allergy and Immunology clinics at CHP
- East Liberty Family Health Center
- Media
- PAT Bus Cards (East Liberty Garage) (6/08)
- CHP Quarterly Newsletter Promises
- CHP phone waiting message
- UPMC Extra
- Pittsburgh Parent Magazine
- City Paper
26PASS Demographics CHP
27Challenges Lessons from the field
- 1. Human subject protection
- 2. Recruitment
- 3. Retention
- 4. Psychosocial complexities
28PASS Describe the scope of psychosocial
complexities
- Examined all events IRB-reportable and
non-reportable documented occurrences - Event types
- Serious adverse events
- Adverse events
- Unanticipated problems
- Protocol deviation
- Notes to file
- Withdrawals
29Event Frequency
Events IRB-reportable and documented
non-reportable occurrences 4 withdrawals were
included but not considered significant or
relevant events 2 withdrawals were included but
not considered significant or relevant events
30Events Themes
- Legal
- Psychiatric co-morbidity
- Psychosocial complexity
- Illicit drug use
- Lack of social supports
31Legal Issues
- Arrest
- Detention/Incarceration
- Custody issues
- Change in custody
- Unclear legal guardianship
Legal issues increased demands on study resources
and negatively affected retention.
32Psychiatric Co-morbidity
- Psychiatric hospitalizations
- Crisis intervention/Psychiatric ER services
- Psychiatric impairment
- Reporting issues
Extent of psychiatric co-morbidity resulted in
unanticipated staff and study resource demands
these observations suggested the need for
specialized training for research staff and the
need to broaden our research beyond the focus of
tobacco use.
33Psychosocial complexity
- Deaths of family members or friends
- Miscarriages
- CYF involvement
- Partner abuse
- Victims of assault
- Homelessness and hunger
Responding to these psychosocial complexities
consumed personnel resources and often required a
level of professional expertise not anticipated
in study preparation. The stress in these
youths lives reflects a burden of health risks
that go beyond smoking and call for a look at the
social environment that influences these
behaviors.
34Illicit drug use
- Rehab hospitalization
- Safety concerns
- Reporting issues
- Interferes with intervention
Tobacco use screening needs to include specific
questions about cigarette smoking as opposed to
merely querying about smoking.
35Lack of supports
- Misrepresenting age or identity
- Homeless - referred to shelter
- Used research home as resource help with
relapse after study miscarriage. - Child care during visit (not documented)
These cases pointed out that 1) the research site
becomes a research home 2) teens in this
population group are in need of resources beyond
just addressing their smoking and this must be
taken into account when designing and budgeting
for future studies.
36Implications
- Study design
- Broaden research question
- Research staff training
- Budget reconsideration/Resource allocation
- Interdisciplinary collaborations
- IRB
- Adolescent Service delivery professionals/Clinicia
ns - Mental health/Addiction researchers
37Questions for Discussion
- What are some recommendations for responding to
the challenges raised today - How representative is this sample of teen
smokers - To what extent does the requirement for parental
consent skew the sample Does this extent justify
a waiver of parental consent - What can we learn from researchers and health
care professionals who deal with sensitive health
issues to better recruit and retain high risk
youth - How can future studies be designed to address the
larger societal issues of at-risk youth