Challenges in Adolescent Smoking Cessation Research

1. Challenges in Adolescent Smoking Cessation Research Deborah Moss, MD, MPH February 24, 2009

2. OBJECTIVES • Overview of adolescent smoking • Challenges of conducting adolescent cessation research • Lessons from the “field” • Implications

3. Overview 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.

5. Risks 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

6. Youth 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.

7. Effective 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)

8. Viewing smoking related messages increases the likelihood of smoking • Movies (Dalton/Sargent, 2000-2006) • Advertising and promotions (Pierce, 1996-1998)

9. Tried Smoking (percent) James Sargent (2005), www.smokefreemovies.ucsf.edu

10. Teen cessation

11. Do Teens Want to Quit? Yes! 62% of high school students report a desire to stop smoking (Marshall 2006)

12. Do 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

13. Lack of effective treatment recommendations • Insufficient evidence (Grimshaw 2006, Sussman 2006) • Research needs- Cochrane review • Well-designed, adequately powered RCT’s for adolescent smokers • Minimum follow-up of 6 months • Rigorous definition of cessation (sustained, biochemical verification) • Recognize methodologic problems (recruitment, retention, follow-up)

14. Challenges in Youth Tobacco Use Research

15. Challenges in youth tobacco control research 1. Human subject protection 2. Recruitment 3. Retention 4. Psychosocial complexities**

16. 1. 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

17. 2. Recruitment • Accessing teens • Lack of perceived benefit (personal or immediate) • Perceived barriers – loss of privacy, time commitment, transportation • Appealing to adolescent interests

18. 3. Retention • Transience • Maintaining contact • Commitment • Changing motivation • Peer influence

19. 4. 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.

20. PASS Pennsylvania Adolescent Smoking Study (PASS)

21. Primary Care Network for Adolescent Smoking Cessation Research • The Network consists of: • Children’s Hospital of Philadelphia • Children’s Hospital of Pittsburgh • Lehigh Valley Hospital • St. Christopher’s Hospital for Children • University of Pennsylvania

22. PASS-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

23. PASS: 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

24. PASS Recruitment: site comparison

25. PASS: 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 Children’s Hospital (CHP) • Adolescent In-patient Unit at CHP • Primary Care Center at CHP • Family Medicine (Shadyside, Matilda Theis) • Children’s/UPMC at Turtle Creek • Children’s 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 • KennyTales • Craig's List • Flyers posted in local neighborhoods • Facebook

26. PASS Demographics : CHP

27. Challenges: Lessons from the field 1. Human subject protection 2. Recruitment 3. Retention 4. Psychosocial complexities**

28. PASS: 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

29. Event 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

30. Events: Themes • Legal • Psychiatric co-morbidity • Psychosocial complexity • Illicit drug use • Lack of social supports

31. Legal Issues • Arrest • Detention/Incarceration • Custody issues • Change in custody • Unclear legal guardianship Legal issues increased demands on study resources and negatively affected retention.

32. Psychiatric 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.

33. Psychosocial 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 youth’s lives reflects a burden of health risks that go beyond smoking and call for a look at the social environment that influences these behaviors.

34. Illicit 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.

35. Lack 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.

36. Implications • Study design • Broaden research question • Research staff training • Budget reconsideration/Resource allocation • Interdisciplinary collaborations • IRB • Adolescent Service delivery professionals/Clinicians • Mental health/Addiction researchers

37. Questions 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?