Donna Caruthers

A randomized controlled trial of a smoking cessation intervention for pregnant adolescents

Background: The smoking prevalence rate among pregnant adolescents has been estimated at 59-62%, and 60-80% of these adolescents continue to smoke throughout their pregnancies. Objectives: The aim of this study was to evaluate the short- and long-term effects of smoking cessation strategies tailored to the pregnant adolescent to attain and maintain abstinence. The specific aim was to examine differences in short- and long-term smoking behaviors among three groups: Teen FreshStart (TFS), Teen FreshStart Plus Buddy (TFS-B), and Usual Care (UC) control. Methods: In this randomized controlled intervention study, a3-group (TFS, TFS-B, and UC) by 3-occasion (baseline, 8 weeks postrandomization, and 1-year following study entry) design was used. The study included 142 pregnant adolescents who were aged 14 to 19 years. Both self-reported smoking status collected on the Smoking History Questionnaire and saliva cotinine levels were used to identify smoking behaviors. Results: There were no significant differences among the three treatment groups at baseline in terms of the racial distribution, age, gestational age, age of menses initiation, number in family household, number of family members who smoked, or tobacco use. A significant difference between the UC group and the TFS-B group (p = .010) was seen in smoking behaviors measured 8 weeks following treatment initiation. At 1 year following study entry, however, there were no differences between the groups in smoking behaviors. Discussion: The TFS-B intervention was more effective in attaining short-term smoking cessation in the pregnant adolescent than TFS or UC. Findings suggest that the peer-enhanced programming had a limited effect but could not sustain the participant beyond postpartum (1 year following study entry). Future studies should include relapse prevention to sustain smoking abstinence into the postpartum period.

Assessing Fidelity to an Intervention in a Randomized Controlled Trial to Improve Medication Adherence

Background:Behavioral intervention effectiveness in randomized controlled trials requires fidelity to the protocol. Fidelity assessment tools tailored to the intervention may strengthen intervention research. Objective:The aim of this study was to describe the assessment of fidelity to the structured intervention protocol in an examination of a nurse-delivered telephone intervention designed to improve medication adherence. Methods:Fidelity assessment included random selection and review of approximately 10% of the audiorecorded intervention sessions, stratified by interventionist and intervention session. Audiotapes were reviewed along with field notes for percentage of agreement, addressing whether key components were covered during the sessions. Visual analog scales were used to provide summary scores (0 = low to 5 = high) of interaction characteristics of the interventionists and participants with respect to engagement, demeanor, listening skills, attentiveness, and openness. Results:Four nurse interventionists delivered 871 structured intervention sessions to 113 participants. Three trained graduate student researchers assessed 131 intervention sessions. The mean percentage of agreement was 92.0% (±10.5%), meeting the criteria of 90% congruence with the intervention protocol. The mean interventionist interaction summary score was 4.5 ± 0.4, and the mean participant interaction summary score was 4.5 ± 0.4. Discussion:Overall, the interventionists successfully delivered the structured intervention content, with some variability in both the percentage of agreement and quality of interaction scores. Ongoing assessment aids in ensuring fidelity to study protocol and having reliable study results.