Project EX is an 8-session teen school-based clinic tobacco use cessation program that involves the inclusion of enjoyable, motivating activities ("games," "talk show," and alternative medicine-type) to try to enhance quit rates among youth. This clinic program was tested in a 3-group experimental design: clinic only, clinic plus a school-as-community component, and standard care control. Eighteen schools were assigned to the three conditions using a randomized block design. Three hundred and thirty five smokers participated in the study, making this the largest controlled teen smoking cessation field trial conducted to date. Seventeen percent of the smokers enrolled in the clinics had reports of having quit smoking for at least the last 30 days at 3 month follow-up (five months after the program quit day), compared to only 8% of the control condition smokers over than same time period. The Project EX clinic component appears to be an effective means of tobacco use cessation among teens.

Creation of the EX Program     [ Top ]

The starting point for Project EX program development was the cessation program from Project Towards No Tobacco Use. That cessation project tested the efficacy of two tobacco use cessation clinic programs within a traditional high school setting, using a 3-group experimental design. The two curricula were similar in format, but one focused on the chemical dependency aspects of tobacco use while the other focused on psycho-social dependence (perceived social influences) associated with tobacco use. A single, five session clinic was refined from the Project TNT cessation program. The development approach utilized in Project EX was to attempt to add enjoyable and motivating activities to the 5-session TNT program in to enhance quit rates, using an iterative development and evaluation process. First, 19 focus groups were completed with a total of 233 subjects from six CHS’s. The focus groups suggested that activities which emphasize the importance of quitting while one was young, alternatives to smoking, yoga, improvement in mood over time after quitting, looking at ex-smokers as strong people, and use of school events are particularly useful.

Ideas from the focus groups fed into a theme study in which hypothetical activities were presented to students in a written, paragraph form and rated for perceived efficacy. A total of 26 activities were compared. Nine motivational theory driven activities were presented in both "Game" (e.g., student competitions to solve puzzles) and "talk show" (e.g., like "Oprah") teaching modality versions to determine students overall preference for either one of those modalities. In addition, 8 alternative-medicine type activities (e.g., yoga) were also presented to determine student preferences for these novel, atheoretical activities. A total of 391 CHS students from 4 schools participated in that study, and each classroom rated one of two activity sets randomized in order. Talk show and game modalities were equally liked. The highest rated activity was a talk show one which emphasized quitting while one is young. Other highly rated activities related to romantic choices when being tobacco free and not being a victim of tobacco company advertisements. Instruction in yoga also was preferred.

The 14 top rated activities in the theme study were further developed and tested in a "component study" in which complete activity lessons (clinic sessions) were conducted and individually assessed for immediate impact. Four of the activities were talk show modality and five were game-modality. The five other retained activities were novel, alternative medicine-type. A total of 327 students from 3 CHS’s were in the components study. Activity sets were randomly assigned across classrooms such that each student was exposed to five activities over a three-day sequence. The top 8 ranked activities were retained and sequenced into a complete 8 session cessation clinic program.

The final clinic curriculum involves eight sessions delivered over a 6 week period. The first four sessions are held in a two week period. During that period, students are not asked or required to quit immediately, but rather are prepared to strengthen their attempt to quit between Session 4 and Session 6. The second four sessions that are held once per week during the following month and are focused on maintenance of their quit attempt.

Clinic recruitment included use of flyers, brief announcements by project staff in each classroom, word of mouth, and school staff referral. Student participation in cessation clinics was voluntary, and individuals wishing to participate were given credit and class release time. To be eligible for study participation, a student must have used tobacco in the last 30 days prior to the first session, and had to join the clinic in the first 2 of the six weeks (on or before Session 4).

Recruitment and Baseline Comparability     [ Top ]

Based on the school wide tobacco prevalence survey, a total of 772 (54%) of the students at the 12 intervention target schools reported smoking cigarettes within the last 30 days, and the school level prevalence of smoking did not vary across the program conditions. A total of 259 (34%) of the target population enrolled in the clinics, 139 at the clinic only schools and 120 in the clinic plus SAC schools. All enrollees smoked cigarettes; 46% smoked only cigarettes, 36% smoked both cigarettes and cigars, 6% both smoked cigarettes and used smokeless tobacco, and 12% used all three tobacco products. Among the cigarette smokers, 85% smoked daily with an average of 8.8 cigarettes per day (SD=9.3), based on a two-item index (r=.83) composed of the number of cigarettes reported to be smoked on an average day and the number of cigarettes smoked yesterday. Twenty-five percent scored in a no-or-weak signs of addiction range (0-5), 58% scored in a moderate addiction range (6-13), and 17% scored in a heavy addiction range (14-21). A total of 64% of the sample were male; 47% were Latino, 27% were white, 8% were Asian, 6% were African American, and 12% were "other." The mean age was 16.8 (SD=0.8), with a range from 14-19 years of age. These demographics of the clinic enrollees did not differ significantly between program conditions.

Prior to the clinic, program facilitators visited each classroom at the school and provided a brief 5-minute presentation regarding the availability of a tobacco use quit clinic over the next few weeks. The classroom teacher indicated that elective class credit and class release time would be offered for participation in the quit clinic. At pre-test, clinic participants were asked how they had heard about the clinic and the main reason they came to the clinic. Forty-five percent of the participants indicated that classroom presentations by the facilitator alerted them to the availability of the clinic, while 41% said they were referred by a teacher (32%) or other school staff member (9%). Twelve percent said they heard about the clinic through a friend, and only 2% said it was through a flyer. Ninety percent said they the main reason they came was to get help with quitting tobacco, while only 6% said it was to get class credit, and 4% said it was to get out of class.

The school-as-community (SAC) manipulation appeared to be implemented as designed. There were an average of 10.2 ASB meetings (range=6.5 to 18.9) examined across the six school-as-community schools, over an average of 5 months (range=3 to 7). An average of 15 youths attended each meeting (range=6 to 25; 9% of each school was involved). Tobacco use hazards and tobacco use prevention were emphasized at the schools (i.e., discussed at over half of the meetings); however, tobacco use cessation was only emphasized at two of the schools. All six schools completed 6 events in an average of 5.2 of the 6 categories (range=4 to 6) suggested by the Project TND staff.

Immediate and 3 Month Outcomes     [ Top ]

The end of clinic (immediate) post-test was administered to those completing the clinic only. Those dropping out of the clinic and standard care controls subjects did not take the immediate post test by design but were attempted follow-up at 3 months. In addition to assessing the clinic process items above, tobacco use and cessation stage were assessed as intermediate outcomes. The 30-day abstinence rate at immediate post test was 14% and nearly identical across the two program conditions(chi-square (1)=.01, p>.05).

The follow-up assessments occurred an average of 3.7 months (SD=0.7 months) after the end of the clinic, or approximately 5 months after the clinic target "quit day" in Session 4. A total of 128 (49%) of the 259 clinic enrollees were contacted at follow-up, including 40 (42%) of the 118 clinic drop outs (those who did not complete at least 4 of the 8 clinic sessions). Also, of the 76 smokers targeted to be followed up from the control schools, 44 (58%) were reached at follow-up, for a total follow-up rate of 51% among all those targeted. The follow-up rate did not vary significantly between the three conditions (chi-square (2)=5.00, p>.05). Furthermore, subjects measured at follow-up did not differ significantly from the full sample measured at pretest on any of the pretest variables(all ps >.05); thus, there is no evidence that the follow-up is sample is biased due to differential attrition.

Since follow-up tobacco use and quit rates did not differ across the two program conditions, data were combined. Assuming that all those not contacted at follow-up were still using tobacco, as a means to control for potential bias due to differential loss of follow-up, and adjusting for CO-overreporting of quitting (2%), the 30-day quit rate at follow-up is calculated at 17% across all clinic program enrollees. The quit rate among all the control school smokers using that same assumption is calculated at 8% ( p<.05). Those scoring in the heavier addiction ranges were less likely to quit than those with lower addiction scores in all conditions.