University of Colorado Anschutz
Aurora, Colorado, 80045, United States
NCT Number: NCT05641974
The purpose of this study is to assess the effect of the Helpers Stay Quit training on abstinence over time of newly abstinent smokers, and on the interactions they have with their personal network related to smoking and smoking cessation.
This study is active but is not currently recruiting participants.
18 year–99 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Despite major gains in smoking cessation treatment, over half of recently quit smokers will relapse within the first year. To date, relapse prevention interventions have focused on the newly abstinent smoker ("abstainer"), and not attempted to directly or indirectly influence the abstainer's personal network, e.g. by helping the abstainer influence others in their personal network to quit. Personal networks exert powerful effects on initiating and maintaining smoking behavior, and can facilitate maintaining abstinence or trigger relapse. A "help others" intervention that seeks to increase the abstainer's ability to influence smokers in their personal network to quit - thereby creating a social environment more supportive of long-term abstinence - may have a beneficial effect on relapse. The Helpers Stay Quit intervention encourages abstainers to reinforce their own abstinence through helping others quit, and to proactively influence their personal network to be more conducive to long-term smoking abstinence. Helpers Stay Quit teaches abstainers how to encourage other tobacco users to quit and avoid relapse through a non-confrontational "helping conversation" that encourages quitting and use of evidence-based cessation aids (e.g. Quitlines, cessation medications) without confrontation and nagging. The investigator hypothesizes that Quitline abstainers exposed to Helpers Stay Quit will have higher 30-day and 7-day point prevalence abstinence than those receiving Quitline follow-up usual care, and that the effect of Helpers Stay Quit may be mediated by personal network characteristics. To test this hypothesis, the investigator proposes a pragmatic randomized controlled trial with embedded mixed-methods personal network study to assess the effect of Helpers Stay Quit training on proportion and duration of abstainers' abstinence over time, and on abstainer's personal network interactions related to smoking and smoking cessation. Metrics derived from the personal network study will be used for mediational analyses of overall, and gender-based effects of Helpers Stay Quit on smoking relapse.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Helpers Stay Quit training emphasizes a tobacco-user centered, non-confrontational approach to encouraging others to quit smoking. Helpers Stay Quit trainees learn how to offer a 4-step "helping conversation". The four steps of a helping conversation parallel the 4 core training modules of Helpers Stay Quit (Awareness, Understanding, Helping, Relating). A key learning objective of Helpers Stay Quit, is for Helpers to learn how to manage their own expectations for the process and outcome of a helping conversation (e.g. Helpers are taught that they cannot "make" anyone quit, but they can offer non-judgmental support, and information about effective cessation aids). Consequently, Helpers are taught to manage their own behavior when helping others (e.g. avoiding nagging or pushing a tobacco-user to quit). The helping conversation focuses on encouraging behavior change that is aligned with the tobacco user's current willingness/readiness to take any action toward quitting.
Time frame: Self-reported data collected at 6 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time frame: Self-reported data collected at 12 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time frame: Self-reported data collected at 3- and 9-months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time frame: Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time frame: Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time frame: Weekly data collected months 1-6; bi-weekly data collected months 7-12; data collected at 3-, 6-, 9-, and 12-months post-randomization
Participants report the number of helping conversations (if any) offered within the specified timeframe.
Time frame: Data collected and 6- and 12-months post-randomization
Participants who report abstinence at 6- and 12-months (and no other exposure to nicotine) receive a dried blood spot kit which is returned and tested for cotinine.
University of Colorado, Denver
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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